Obgm Mar2018 Vol.30 No.3

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COM/OBGMANAGEMENT | VOL 30, NO 3 | MARCH 2018 Which antibiotics should

be used with caution in
pregnant women with UTI?
Patrick Duff, MD
The ACOG app and applets:

Tools to augment your practice
Managing hidradenitis suppurativa
Endometriosis
Expert perspectives
on medical and
surgical management
Arnold P. Advincula, MD;
Douglas N. Brown, MD;
Hye-Chun Hur, MD, MPH
Update on cancer
›› Cervical cancer screening
›› SLN biopsy and
endometrial cancer
›› Immunotherapy and gyn cancers
In collaboration with ACOG

The role of patient-reported
outcomes in women’s health
Factors critical
to reducing US
maternal mortality
and morbidity
p. 30
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Kate Macy Ladd Professor of Obstetrics, Gynecology, and Reproductive Biology
Harvard Medical School
Boston, Massachusetts
BOARD OF EDITORS
Arnold P. Advincula, MD David G. Mutch, MD

Vice Chair and Levine Family Professor of Women’s Health, Ira C. and Judith Gall Professor of Obstetrics and Gynecology, and
Department of Obstetrics & Gynecology, Columbia University Vice Chair, Department of Obstetrics and Gynecology, Washington
Medical Center; Chief of Gynecology, Sloane Hospital for Women, University School of Medicine, St. Louis, Missouri
New York-Presbyterian Hospital/Columbia University,
New York, New York
Errol R. Norwitz, MD, PhD, MBA, Section Editor
Chief Scientific Officer, Tufts Medical Center; Louis E. Phaneuf
Linda D. Bradley, MD Professor and Chairman, Department of Obstetrics & Gynecology,
Professor of Surgery and Vice Chairman, Obstetrics, Gynecology, Tufts University School of Medicine, Boston, Massachusetts
and Women’s Health Institute, and Director, Center for Menstrual
Disorders, Fibroids, & Hysteroscopic Services, Cleveland Clinic,
Cleveland, Ohio JoAnn V. Pinkerton, MD, NCMP
Professor, Department of Obstetrics and Gynecology, and
Director, Midlife Health, University of Virginia Health System,
Amy L. Garcia, MD
Charlottesville, Virginia; Executive Director, The North American
Medical Director, Garcia Sloan Centers,
Menopause Society, Pepper Pike, Ohio
Center for Women’s Surgery, and Clinical Assistant Professor,
Department of Obstetrics and Gynecology,
University of New Mexico, Albuquerque, New Mexico John T. Repke, MD
University Professor, Department of Obstetrics and Gynecology,
Steven R. Goldstein, MD, NCMP, CCD Penn State University College of Medicine, Hershey, Pennsylvania
Professor, Department of Obstetrics and Gynecology,
New York University School of Medicine; Director, Gynecologic Joseph S. Sanfilippo, MD, MBA
Ultrasound, and Co-Director, Bone Densitometry and Body Professor, Department of Obstetrics, Gynecology, and
Composition, New York University Medical Center, Reproductive Sciences, University of Pittsburgh;
New York, New York Academic Division Director, Reproductive Endocrinology
and Infertility, Magee-Womens Hospital,
Cheryl B. Iglesia, MD Pittsburgh, Pennsylvania
Director, Section of Female Pelvic Medicine and Reconstructive
Surgery, MedStar Washington Hospital Center;
James A. Simon, MD, CCD, IF, NCMP
Professor, Departments of ObGyn and Urology,
Clinical Professor, Department of Obstetrics and Gynecology,
Georgetown University School of Medicine, Washington, DC
George Washington University; Medical Director, Women’s Health
& Research Consultants, Washington, DC
Andrew M. Kaunitz, MD, NCMP, Section Editor
University of Florida Term Professor and Associate Chairman,
Department of Obstetrics and Gynecology, University of Florida
College of Medicine-Jacksonville; Medical Director and Director
of Menopause and Gynecologic Ultrasound Services, UF Women’s
Health Specialists at Emerson, Jacksonville, Florida
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41 App Review
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KATHERINE T. CHEN, MD, MPH
45 What’s Your Diagnosis?

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DEVARAJU KANMANIRAJA, MD,
AND ANDREW M. KAUNITZ, MD
9 EDITORIAL
Hidradenitis suppurativa:
An underdiagnosed skin problem
of women
34 Roundtable ROBERT L. BARBIERI, MD
Endometriosis: 13 COMMENT & CONTROVERSY

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EDITORIAL
Hidradenitis suppurativa:
An underdiagnosed skin problem of women
Gynecologists are uniquely positioned to diagnose this common
skin problem
Robert L. Barbieri, MD
Editor in Chief, OBG ManageMent
Chair, Obstetrics and Gynecology
Brigham and Women’s Hospital, Boston, Massachusetts
Kate Macy Ladd Professor of Obstetrics,
Gynecology and Reproductive Biology
Harvard Medical School, Boston
I
n recent decades the practice of disrobe and examining the skin. onset of the disease and the diagno-
medicine has drifted away from Gynecologists are uniquely posi- sis by a clinician.7 Delay in diagnosis
the performance of a physical tioned to diagnose important skin results in increased scarring, which
examination during most patient diseases because, while performing makes it more difficult to effectively
encounters and evolved toward the a reproductive health examination, treat the disease. In this editorial, I will
more intensive use of history, imag- they may be the first clinicians to focus on the pathogenesis, diagnosis,
ing, and laboratory studies to guide directly examine the anogenital area and treatment of HS.
management decisions. For exam- and inner thighs. Skin diseases that
ple, it is common for a woman to are prevalent and can be diagnosed Diagnosis, presentation,
present to an emergency department while performing an examination of and staging
with abdominal or pelvic pain and the anogenital region include lichen Hidradenitis suppurativa (from the
undergo a computerized tomogra- sclerosus (LS) and hidradenitis sup- Greek, hidros means sweat and aden
phy scan before an abdominal and purativa (HS). The prevalence of each means glands) is a painful, chronic,
pelvic examination is performed. of these conditions is in the range of relapsing, inflammatory skin disorder
Some authorities believe that the 1% to 4% of women.3–5 affecting the follicular unit. It is mani-
trend to reduce the importance of the Failure to examine the anogenital fested by nodules, pustules, sinus
physical examination has gone way area and insufficient attention to the tracts, and scars, usually in intertrigi-
too far and resulted in a reduction in early signs of LS and HS may result nous areas. The diagnosis is made by
the quality of health care.1,2 in a long delay in the diagnosis.6 In history and physical examination. The
Many skin diseases only can 1 survey, of 517 patients with HS, there 3 cardinal features of HS are 1) deep-
be diagnosed by having the patient was a 7-year interval between the seated nodules, comedones, and
fibrosis; 2) typical anatomic location
Instant Poll of the lesions in the axillae, inguino-

crural, and anogenital regions, and
3) chronic relapsing course.8
Do you think that the trend to not perform a physical examination Disease severity is often assessed
has adversely impacted patient care? Without violating HIPAA using the Hurley staging system:
provisions, are you aware of a case example of how not performing • stage I: abscess formation without
a physical examination adversely impacted patient care? sinus tracts or scarring (FIGURE,
page 10)
Tell us at rbarbieri@frontlinemedcom.com • stage II: recurrent abscesses with
Please include your name and city and state. tract formation and scarring,
widely separated lesions
CONTINUED ON PAGE 10
mdedge.com/obgmanagement Vol. 30 No. 3 | March 2018 | OBG Management 9
Editorial 0318.indd 9 2/27/18 1:59 PM

EDITORIAL
CONTINUED FROM PAGE 9
dermis, thereby triggering inflamma- suppress androgen production or

tion, bacterial infection, and scarring. action may help reduce HS disease
Dermal areas affected by HS have high activity. For women with HS who also
concentrations of cytokines, including need contraception, an estrogen-
tumor necrosis factor (TNF)–alpha, progestin contraceptive may help
interleukin (IL)-1-beta, IL-23, and reduce HS disease activity in up to
IL-32.11,12 Once HS becomes an estab- 50% of individuals.19 The 5-alpha
lished process, it is difficult to treat reductase inhibitor finasteride, at
because the dermal inflammatory high doses (5 to 15 mg daily), has
process and scarring provides a micro- been reported to reduce HS dis-
environment that facilitates disease ease activity.20,21 Finasteride is a
progression. Hence early detection teratogen, and the FDA strongly
and treatment may result in optimal recommends against its use by
long-term outcomes. women. Spironolactone, an anti-
mineralocorticoid and antiandro-
Treatment gen, at a dose of 100 mg daily has
Many recommended treatments for been reported to reduce disease
FIGURE Multiple inflammatory nodules
HS have not been formally tested activity in about 50% of treated indi-
in the genital area without sinus tracts
or fistulas, classified as Hurley stage I in large randomized trials. A recent viduals and is FDA approved for use
disease. Cochrane review identified only in women.22 Among reproductive-
Image courtesy of Cosmetic Dermatology.
2011;24:226–238. ©2011, Frontline Medical
12 high-quality trials and the median age women, spironolactone, which
Communications Inc. number of participants was 27 per is a teratogen, only should be pre-
trial.13 Consequently, most treat- scribed to women using an effective
ment recommendations are based form of contraceptive. HS is often
• stage III: diffuse or near-diffuse on expert opinion. Recommended associated with obesity and insulin
involvement or multiple intercon- treatments include smoking cessa- resistance. Metformin 500 mg three
nected tracts and abscesses. tion, weight loss, topical and systemic times daily has been reported to
In one report, stage I, II, and III dis- antibiotics, antiandrogens, anti- decrease disease activity.23,24
ease was diagnosed in 65%, 31%, inflammatory biologics (adalimumab Stage II or III management. For
and 4% of cases, respectively, indi- and infliximab), and surgery. Smok- Hurley stage II or III HS, referral to
cating that most HS is diagnosed in ing cessation and weight loss are a dermatologist is warranted. There
stage I and suitable for treatment by strongly recommended in the initial is evidence that too few people with
a gynecologist.9 treatment of HS. Bariatric surgery and HS are referred to a dermatologist.25
HS typically presents after significant postprocedure weight loss For severe HS resistant to oral medi-
puberty and women are more has been reported to cause a reduc- cations, anti-TNF monoclonal anti-
commonly affected than men. In tion in disease activity.14 body treatment with adalimumab
one case series including 232 women Stage I management. For the initial (Humira) or infliximab (Remicade)
with HS the regions most commonly treatment of stage I HS, clindamycin is effective. Adalimumab is adminis-
affected were: axillae, inguinofemo- gel 1% applied twice daily to affected tered by subcutaneous injection and
ral, urogenital, and buttocks in 79%, areas is recommended.15 Recom- is US Food and Drug Administration
77%, 51%, and 40% of cases, respec- mended oral antibiotic treatments (FDA)–approved to treat HS. Fol-
tively.10 Risk factors for HS include include tetracycline 500 mg twice lowing a loading dose, adalimumab
obesity, cigarette smoking, tight fit- daily for 12 weeks16 or doxycycline is administered weekly at a dose of
ting clothing, and chronic friction 100 mg or 200 mg given daily for 40 mg.26 Infliximab, which is not FDA
across the affected skin area.5 10 weeks or clindamycin 300 mg approved to treat HS, is administered
twice daily plus rifampicin 600 mg by intravenous infusion at a dose of
Pathogenesis once daily for 10 weeks.17,18 These 5 mg/kg at weeks 0, 2, and 6, and
The pathophysiology of HS is thought antibiotics have both antimicrobial then every 8 weeks.27
to begin with occlusion of the follicle, and anti-inflammatory effects. Surgical management. HS is
resulting in follicle rupture deep in the Hormonal interventions that sometimes treated surgically with

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EDITORIAL
laser destruction of lesions, punch Physical examination vital to they have a skin disease, or they may
debridement, or wide excision of early diagnosis be embarrassed to show a clinician a
diseased tissue.28,29 There are no Delay in diagnosis of an active dis- skin change they have noticed. Early
high quality clinical trials of surgi- ease process has many causes, diagnosis and treatment are essen-
cal treatment of HS. Punch debride- including nonperformance of a tial to achieving a good outcome and
ment can be performed using a 5- to physical examination. In a web- make a tremendous difference in the
7-mm circular skin punch to deeply based survey of physicians’ experi- quality of life for the patient. Physi-
excise the inflamed follicle. Wide ences with oversights related to the cal examination is a skill we have
excision can be followed by wound physical examination, 3 problems learned through diligent study and
closure with advancement flaps or frequently reported were: nonper- experience in practice. We can use
split-thickness skin grafting. Wound formance of any portion of the phys- these skills to greatly improve the
closure by secondary intention is ical examination, failure to undress lives of our patients.
possible but requires many weeks the patient to examine the skin, and
or months of burdensome dressing failure to examine the abdomen and
changes to complete the healing pro- anogenital region in a patient with
cess. Recurrence is common follow- abdominal or pelvic pain.31 Over-
ing surgical therapy and ranges from sights in the physical examination R B AR B IE R I@F R O N T LIN E M E D C O M . C O M
30% with deroofing or laser treatment frequently caused a delay in diagno-

to 6% following wide excision and sis and treatment. With both LS and Dr. Barbieri reports no financial rela-
skin graft closure of the wound.30 HS, patients may not recognize that tionships relevant to this article.
References
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N Engl J Med. 2006;354(6):548–551. expressed in lesions of hidradenitis suppurativa. Clin Exp Dermatol. 2009;34(8):920–921.
2. Feddock CA. The lost art of clinical skills. Am J Br J Dermatol. 2017;177(5):1358–1366. 24. Verdolini R, Clayton N, Smith A, Alwash N, Man-
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9. Revuz J. Hidradenitis suppurativa. J Eur Acad Der- rativa. Br J Dermatol. 1986;115(3):263–268. of mild to moderate hidradenitis suppurativa
matol Venereol. 2009;23(9):985–998. 20. Joseph MA, Jayaseelan E, Ganapathi B, Stephen J. lesions. J Am Acad Dermatol. 2010;63(3):475–480.
10. Canoui-Poitrine F, Revuz JE, Wolkenstein P, et al. Hidradenitis suppurativa treated with finasteride. 30. Mehdizadeh A, Hazen PG, Bechara FG, et al.
Clinical characteristics of a series of 302 French J Dermatolog Treat. 2005;16(2):263–268. Recurrence of hidradenitis suppurativa after sur-
patients with hidradenitis suppurativa, with an 21. Randhawa HK, Hamilton J, Pope E. Finasteride gical management: a systematic review and meta-
analysis of factors associated with disease sever- for the treatment of hidradenitis suppurativa analysis. J Am Acad Dermatol. 2015;73(5 suppl
ity. J Am Acad Dermatol. 2009;61(1):51–57. in children and adolescents. JAMA Dermatol. 1):S70–S77.
11. Shah A, Alhusayen R, Amini-Nik S. The criti- 2013;149(6):732–735. 31. Verghese A, Charlton B, Kassirer JP, Ramsey M,
cal role of macrophages in the pathogen- 22. Lee A, Fischer G. A case series of 20 women with Ioannidis JP. Inadequacies of physical examina-
esis of hidradenitis suppurativa. Inflamm Res. hidradenitis suppurativa treated with spironolac- tion as a cause of medical errors and adverse
2017;66(11):931–945. tone. Australas J Dermatol. 2015;56(3):192–196. events: a collection of vignettes. Am J Med.
12. Thomi R, Yerly D, Yawalkar N, Simon D, 23. Arun B, Loffeld A. Long-standing hidradenitis 2015;128(12):1322–1324.e3

COMMENT & CONTROVERSY
RECOGNIZE AND TREAT and measurement of vitamin B12 and
IRON DEFICIENCY ANEMIA IN folate levels to identify cases of anemia
PREGNANT WOMEN
JULIANNA SCHANTZ-DUNN, MD, caused by thalassemia or vitamin defi-
MPH, AND ROBERT L. BARBIERI, MD ciency. I agree with Dr. Jackson that
(EDITORIAL; DECEMBER 2017) oral iron supplementation along with
Consider thalassemia patient education can resolve most
traits in patients with cases of iron deficiency in early and
iron deficiency mid-pregnancy. However, in the last
The editorial is an excellent review few weeks of pregnancy there may not
of iron deficiency as an associated be sufficient time for oral iron supple-
finding with adverse health and mentation to be effective in resolving
pregnancy outcomes. However, iron deficiency anemia. In this situ-
one genetic issue appears to have ation and in patients at high risk for
escaped comment. In Florida, our malabsorption, including women with
African American patients have a prior gastric bypass, intravenous iron
commonly found association with might be the best approach to resolv-
microcytic anemia at least as often ing the anemia.
DECEMBER 2017
as iron deficiency: a variety of α- and
ß-thalassemia traits that may occur meticulously monitor compliance. I
individually or together. Other racial have been through the “slow Fe” and STOP USING CODEINE,
OXYCODONE, HYDROCODONE,
groups, including Mediterranean the “prenatal vitamins have iron”
TRAMADOL, AND ASPIRIN IN
and Asian patients, also may carry nonsense. Ferrous sulfate is about as WOMEN WHO ARE BREASTFEEDING
both the α- and ß-thalassemia traits. good as anything. I have explained the ROBERT L. BARBIERI, MD
(EDITORIAL; OCTOBER 2017)
Your recommendation to rou- theory of vitamin C−assist and found
tinely screen for ferritin deficit is laud- that telling people to avoid taking iron An either/or choice is not a
able as a general health care practice. with meals is folly. good strategy for pain
If the screening result is normal, how- I suggest that the iron story I found Dr. Barbieri’s editorial on
ever, consider thalassemia carrier is complete. Rather than wast- postpartum opioid use and breast-
states as a secondary explanation as ing money on further research, we feeding interesting, but one key issue
well as a genetic issue requiring part- should spend funds on teaching was not addressed: Following this
ner testing. Aggressive iron loading young physicians to educate patients guidance means that new mothers
of a nondeficient anemic patient can and monitor compliance. In recent have to choose between breastfeeding
risk excess absorption, storage, and years, I have found that a daily text and pain control. You may explain to
ultimate organ compromise in later message to the patient frequently is a patient with 2-day cesarean delivery
life if continued indefinitely. very helpful. pain, “If you take pain medicine while
Richard P. Perkins, MD Robert W. Jackson, MD breastfeeding, it can adversely affect
Fort Myers, Florida Washougal, Washington the baby. So we will give you acet-
aminophen.” While some moms will
Patient education is key to Dr. Barbieri responds deal with it, others will stop breast-
managing iron deficiency I thank Drs. Perkins and Jackson for feeding. With the increasing pressure
Forty years ago, my professors their helpful recommendations for to advocate for breastfeeding, this
expounded on how some people the management of iron deficiency strategy is likely not realistic.
could not absorb iron and that the anemia. I agree with Dr. Perkins that R. Lee Toler, DO
answer was intravenous iron infu- screening for thalassemia is an impor- Bolivia, North Carolina
sion. After writing a few prescriptions, tant part of preconception and prena-
however, I found that I no longer had tal care. In the editorial’s table on page My pain management
patients with absorptive problems 10 discussing the differential diagnosis protocol
once I learned to carefully, and with of anemia, we mentioned the impor- While presently in an office-based
visual aids, explain the iron story and tance of hemoglobin electrophoresis setting, back in my inpatient practice
2/27/18 2:00 PM
Examining the EVIDENCE
Which antibiotics should be

used with caution in pregnant
women with UTI?
Nitrofurantoin and trimethoprim-
sulfamethoxazole have study data indicating their
teratogenicity, and ACOG has recommended against use
of these 2 agents in the first trimester of pregnancy unless
other antibiotics are unlikely to be effective. Despite this
recommendation, a recent large commercial database study
indicated that 43% of women were prescribed nitrofurantoin
or trimethoprim-sulfamethoxazole in their first trimester.
These agents should be used with caution during the early
part of pregnancy.
FAST
TRACK Ailes EC, Summers AD, Tran EL, et al. Antibiotics dispensed One goal of treating asymptomatic
to privately insured pregnant women with urinary tract bacteriuria and acute cystitis is to prevent
One goal of treating infections—United States, 2014. MMWR Morb Mortal ascending infection (pyelonephritis), which
bacteriuria and Wkly Rep. 2018;67(1):18–22. can be associated with preterm delivery, sep-
cystitis is to prevent sis, and adult respiratory distress syndrome.
ascending infection EXPERT COMMENTARY Another key goal is to use an antibiotic that
(pyelonephritis); Patrick Duff, MD, is Associate Dean for Student
Affairs and Professor of Obstetrics and Gynecology in
eradicates the uropathogen without causing
another is to the Division of Maternal-Fetal Medicine, Department of harm to either the mother or fetus.
use an antibiotic Obstetrics and Gynecology, University of Florida Col- In 2009, Crider and colleagues reported
that eradicates lege of Medicine, Gainesville. that 2 of the most commonly used antibiotics
the uropathogen for UTIs, sulfonamides and nitrofurantoin,
L
without causing ower urinary tract infection (UTI) is were associated with a disturbing spectrum
harm to the mother one of the most common medical of birth defects.1 Following that report, in
or fetus complications of pregnancy. Approxi- 2011 the American College of Obstetricians
mately 5% to 10% of all pregnant women and Gynecologists (ACOG) published a com-
have asymptomatic bacteriuria, which usu- mittee opinion that recommended against
ally antedates the pregnancy and is detected the use of these 2 agents in the first trimester
at the time of the first prenatal appointment. of pregnancy unless other antibiotics were
Another 2% to 3% develop acute cystitis dur- unlikely to be effective.2
ing pregnancy. The dominant organisms that
cause lower UTIs in pregnant women are Details of the study
Escherichia coli, Klebsiella pneumoniae, Pro- Centers for Disease Control and Prevention
teus species, group B streptococci, entero- investigators recently conducted a study to
cocci, and Staphylococcus saprophyticus. assess the effect of these ACOG recommen-
The author reports no financial relationships relevant dations on clinical practice. Ailes and co-
to this article. workers used the Truven Health MarketScan
Evidence 0318.indd 14 2/27/18 2:01 PM

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Examining the EVIDENCE
Commercial Database to examine antibi- Antibiotic-associated effects

otic prescriptions filled by pregnant women Of all the antibiotics that could be used to
with UTIs. treat a lower UTI in pregnancy, nitrofuran-
The database included 482,917 preg- toin probably has the greatest appeal. The
nancies in 2014 eligible for analysis. A total drug is highly concentrated in the urine and
of 7.2% (n = 34,864) of pregnant women were is very active against all the common uro-
treated as outpatients for a UTI within the pathogens except Proteus species. It is not
90-day interval before the last menstrual absorbed significantly outside the lower
period or during the pregnancy. Among these urinary tract, and thus it does not alter the
women, the most commonly prescribed natural flora of the bowel or vagina (such
antibiotics during the first trimester were alteration would predispose the patient to
nitrofurantoin (34.7%), ciprofloxacin (10.5%), antibiotic-associated diarrhea or vulvovagi-
cephalexin (10.3%), and trimethoprim- nal candidiasis). Nitrofurantoin is inexpen-
sulfamethoxazole (7.6%). sive and usually is very well tolerated.
The authors concluded that 43% of In the National Birth Defects Prevention
women used an antibiotic (nitrofurantoin or Study by Crider and colleagues, nitrofuran-
trimethoprim-sulfamethoxazole) in the first toin was associated with anophthalmia or
trimester that had potential teratogenicity, microphthalmos (adjusted odds ratio [AOR],
despite the precautionary statement articu- 3.7; 95% confidence interval [CI], 1.1–12.2),
lated in the ACOG committee opinion.2 hypoplastic left heart syndrome (AOR, 4.2;
95% CI, 1.9–9.1), atrial septal defects (AOR,
1.9; 95% CI, 1.1–3.4), and cleft lip with cleft
WHAT THIS EVIDENCE MEANS FOR PRACTICE
palate (AOR, 2.1; 95% CI, 1.2–3.9).1 Other
Pending the publication of additional investigations, I believe that investigations, including one published as
the guidance outlined below is prudent. recently as 2013, have not documented these
Trimethoprim-sulfamethoxazole should not be used for treating same associations.3
UTIs in the first trimester of pregnancy unless no other antibiotic Similarly, the combination of
is likely to be effective. This drug also should be avoided just trimethoprim-sulfamethoxazole also has
prior to expected delivery because it can displace bilirubin from considerable appeal for treating lower UTIs
protein-binding sites in the newborn and increase the risk of neo- in pregnancy because it is highly active
natal jaundice. against most uropathogens, is inexpensive,
There may be instances in which trimethoprim-sulfamethoxazole and usually is very well tolerated. The report
should be used even early in pregnancy, such as to provide
by Crider and colleagues, however, was even
prophylaxis against Pneumocystis jiroveci infection in women with
more worrisome with respect to the possible
human immunodeficiency virus.
To exercise an abundance of caution, I recommend that nitro-
teratogenicity of this antibiotic.1 The authors
furantoin not be used in the first trimester of pregnancy unless no found that use of this antibiotic in the first
other antibiotic is likely to be effective. trimester was associated with anencephaly
Alternative antibiotics that might be used in the first trimester (AOR, 3.4; 95% CI, 1.3–8.8), coarctation of
for treatment of UTIs include ampicillin, amoxicillin, cephalexin, the aorta (AOR, 2.7; 95% CI, 1.3–5.6), hypo-
and amoxicillin-clavulanic acid. Substantial evidence supports plastic left heart (AOR, 3.2; 95% CI, 1.3–7.6),
the safety of these antibiotics in early pregnancy. Unless no other choanal atresia (AOR, 8.0; 95% CI, 2.7–23.5),
drug is likely to be effective, I would not recommend use of a transverse limb deficiency (AOR, 2.5; 95% CI,
quinolone antibiotic, such as ciprofloxacin, because of concern 1.0–5.9), and diaphragmatic hernia (AOR,
about the possible injurious effect of these agents on cartilagi-
2.4; 95% CI, 1.1–5.4). Again, other authors,
nous tissue in the developing fetus.
using different epidemiologic methods, have
Neither trimethoprim-sulfamethoxazole nor nitrofurantoin
not found the same associations.3
should be used at any time in pregnancy in a patient who has
glucose-6-phosphate dehydrogenase deficiency or who may be at
increased risk for this disorder.2 Study strengths and weaknesses
PATRICK DUFF, MD The National Birth Defects Prevention
Study by Crider and colleagues was a large,
Evidence 0318.indd 16 2/27/18 2:01 PM

well-funded, and well-designed epide- recall the exact name of the antibiotic they
miologic study. It included more than received. The authors did not precisely dis-
13,000 patients from 10 different states. tinguish between single-agent sulfonamides
Nevertheless, the study had certain limi- and the combination drug, trimethoprim-
tations.4 The findings are subject to recall sulfamethoxazole, although it seems rea-
bias because the investigators questioned sonable to assume that the majority of the
patients about antibiotic use after, rather prescriptions were for the latter. Finally,
than during, pregnancy. Understandably, given the observational nature of the study,
the investigators were not able to verify the the authors could not be certain that the
prescriptions for antibiotics by reviewing observed associations were due to the anti-
each individual medical record. In fact, one- biotic, the infection for which the drug was
third of study participants were unable to prescribed, or another confounding factor.
References
1. Crider KS, Cleves MA, Reefhuis J, Berry RJ, Hobbs CA, Hu DJ. 3. Nordeng H, Lupattelli A, Romoren M, Koren G. Neonatal
Antibacterial medication use during pregnancy and risk of outcomes after gestational exposure to nitrofurantoin. Obstet
birth defects: National Birth Defects Prevention Study. Arch Gynecol. 2013;121(2 pt 1):306–313.
Pediatr Adolesc Med. 2009;163(11):978–985. 4. American College of Obstetricians and Gynecologists
2. American College of Obstetricians and Gynecologists Committee on Obstetric Practice. ACOG Committee Opinion
Committee on Obstetric Practice. ACOG Committee Opinion No. 717: Sulfonamides, nitrofurantoin, and risk of birth
No. 494: Sulfonamides, nitrofurantoin, and risk of birth defects. Obstet Gynecol. 2017;130(3):e150–e152. doi:10.1097
defects. Obstet Gynecol. 2011;117(6):1484–1485. /AOG.0000000000002300.
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Evidence 0318.indd 17 2/27/18 2:01 PM

VALUE-BASED MEDICINE: PART 3

in women’s health
Patient-reported outcomes, obtained with a validated survey instrument, are
critical to improving clinical research, health care quality, and patient care.
Using them in women’s health care will benefit both patients and clinicians.
Here’s how.
Kimberly D. Gregory, MD, MPH; Lisa M. Korst, MD, PhD; Samia Saeb, MPH;
and Moshe Fridman, PhD
I
n its landmark publication, “Crossing the patients need or want from their treatment or
quality chasm: A new health system for interaction with the health care system.
the 21st century,” the Institute of Medicine Measuring patient-reported outcomes
IN THIS (now the National Academy of Medicine) (PROs) is an attempt to recognize and ad-
ARTICLE called for an emphasis on patient-centered dress patient concerns. Although currently
care that it defined as “Providing care that PROs are focused primarily in the arena of
Standardized is respectful of and responsive to individual clinical research, their use has the potential
PROs patient preferences, needs, and values and to transform daily clinical patient encounters
ensuring that patient values guide all clinical and improve the cost and quality of health
page 19
decisions.”1 Studies suggest that the patient’s care.3
view of health care delivery determines out- In this article, we provide a brief over-
Evolving use come and satisfaction.2 Therefore, we need view of PROs and describe how they can be
of PROs to expend more effort to understand what used to improve individual patient care, clini-
page 20 cal research, and health care quality. We also
offer examples of how PROs can be used in
PROs in women’s Dr. Gregory is Vice Chair, Women’s Healthcare Quality specific women’s health conditions.
and Performance Improvement; Professor, Department of
health care Obstetrics and Gynecology; Division and Fellowship Director,
page 22 Maternal Fetal Medicine; Cedars-Sinai Medical Center, Burns
and Allen Research Institute, Los Angeles, California. What exactly are PROs?
Dr. Korst is Senior Scientist, Childbirth Research Associates, PROs are reports of the status of a patient’s
LLC, Los Angeles. health condition, health behavior, or expe-
Ms. Saeb is Clinical Research Coordinator, Cedars-Sinai rience with health care; they come directly
Medical Center, Department of Obstetrics and Gynecology,
Burns and Allen Research Institute, Los Angeles.
from the patient, without anyone else (such
as a clinician or caregiver) interpreting the
Dr. Fridman is Director, AMF Consulting, Los Angeles.
patient’s response.4 PROs usually pertain to
The authors report no financial relationships relevant to this general health, quality of life, functional sta-
article.
tus, or preferences associated with health
Developed in collaboration with care or treatment.5 Usually PROs are elic-
the American College of
Obstetricians and Gynecologists
ited via a self-administered survey and pro-
vide the patient’s perspective on treatment
Gregory 0318.indd 18 2/27/18 2:03 PM

FAST
benefits, side effects, change in symptoms, provided iterative guidance, including the US TRACK
general perceptions of feelings or well-being, Food and Drug Administration (FDA), Euro-
or satisfaction with care. Often they represent pean Medicines Agency, National Institutes PROs often
the outcomes that are most important to pa- of Health (NIH) Patient-Reported Outcomes represent the
tients.6 The survey usually consists of several Measurement Information System (PROMIS), outcomes that
questions or items. It can be general or con- International Consortium for Health Out- are most important
dition specific, and it may represent one or comes Measurement (ICHOM), University of to patients
more health care dimensions. Oxford Patient Reported Outcomes Measure-
The term patient-reported outcome mea- ment Group, Cochrane Systematic Reviews,
sure (PROM) refers to the survey instrument Consolidated Standards of Reporting Tri-
used to collect PROs. Patient-reported experi- als–Patient Reported Outcomes (CONSORT-
ence measures (PREMs), such as satisfaction PRO) extension (how to report PROs with the
surveys, are considered a subset of PROMs.7 CONSORT checklist), and the International
ILLUSTRATION: PAUL ZWOLAK FOR OBG MANAGEMENT
Society for Pharmacoeconomics and Out-

Standardized PROs developed comes Research (ISPOR).4,5,8–18
out of clinical trials In the United States, the RAND Medi-
The use of PROs evolved from clinical tri- cal Outcomes Study led to the development
als. The proliferation of PROs resulted in an of the 12- and 36-item short form surveys,
inability to compare outcomes across trials which are widely recognized and commonly
or different conditions. This led to a need to used PROMs for health-related quality of
standardize and possibly harmonize mea- life.19 The study generated multiple addi-
sures and to reach consensus about prop- tional survey instruments that evaluate other
erties required for a “good” measure and domains and dimensions of health. These
requirements needed for “adequate” re- surveys have been translated into numerous
porting. Many investigators and several na- languages, and the RAND website lists over
tional and international organizations have 100 publications.19 CONTI NUED ON PAGE 20
Gregory 0318.indd 19 2/27/18 2:03 PM

In 2002, the NIH sponsored PROMIS, a Use of PROs is evolving

cooperative program designed to develop, Historically, PROMs have been used primar-
validate, and standardize item banks to mea- ily in clinical trials to document the relative
sure PROs that were relevant across multiple, benefits of an intervention. With today’s fo-
common medical conditions. Based on liter- cus on patient-centered care, however, there
ature review, feedback from both healthy and is a growing mandate to integrate PROMs into
sick patients, and clinical expert opinion, the clinical care, quality improvement, and ulti-
PROMIS investigators developed a consen- mately reimbursement. Recently, Basch and
sus-based framework for self-reported health colleagues eloquently described the benefit
that included the following domains: pain, of routine collection of PROs for cancer pa-
fatigue, emotional distress, physical func- tients and the opportunity for improved care
tioning, and social role participation; these across the health system.20
domains were evaluated on paper or with PROs can be applied on various levels.
computer-assisted technology.11–14 PROMIS For example, if a patient reports a symptom
is now a web-based resource with approxi- (X), or a change in symptom X, the following
mately 70 domains pertinent to children and options are possible:
adults in the general population and in those • Clinician level: Symptom management
with chronic disease. Measures have been with altered dose or change in medica-
translated into more than 40 languages, and tion. This is associated with improved self-
PROMIS-related work has resulted in more efficacy for the patient, a shift toward goal-
than 400 publications.14 oriented care, improved communication
In 2006, the FDA issued a draft docu- with the provider, and improved patient
ment regarding the PRO standards that satisfaction.
FAST should be included in clinical trials for con- • Researcher level: PROs should be used
TRACK sideration of drug and device applications as a primary end point, in addition to tradi-
(TABLE 1 ). These recommendations, updated tional outcomes (mortality, survival, physi-
With today’s in 2009, were largely drawn from work pub- ologic markers), to allow for comparative
focus on patient- lished by PROMIS and University of Oxford effectiveness studies or patient-centered
centered care, investigators.4,14,16 outcomes research studies that evaluate
there is a growing Because PROs are infrequently mea- what matters most to patients relative to
mandate to sured in routine clinical practice and PROMs the specific health condition, intervention,
integrate PROMs that are used vary between countries, global and symptom management.
into clinical comparison is difficult. Hence, ICHOM con- • Health system level: Quality assurance,
care, quality vened in 2012 to develop consensus-based, quality improvement activities. How ef-
improvement, globally agreed on sets of outcomes that fective is the health system in the man-
and ultimately are intended to reflect what matters most to agement of symptom X? Are all clinicians
reimbursement patients. using the same medication or the same
ICHOM specified 2 goals: 1) the core sets dose? Is there a best practice for managing
should be used in routine clinical practice, symptom X?
and 2) the core sets should be used as end • Population level: Provides evidence for
points in clinical studies.15 other clinicians and patients to make deci-
As of May 2015, 12 standard sets of out- sions about what to expect with treatment
comes have been developed, representing for symptom X.
35% of the global burden of disease. ICHOM From a reimbursement level, clini-
currently is creating networks of hospitals cians and providers are paid based on per-
around the world to begin measuring, bench- formance—the more satisfied patients are
marking, and performing outcome compari- about X, the higher the reimbursement. This
sons that can ultimately be used to inform has been pertinent particularly in high-vol-
global health system learning and clinical ume orthopedic conditions in which ana-
care improvement.15 tomic correction of hip or knee joints has not
Gregory 0318.indd 20 2/27/18 2:03 PM

TABLE 1PRO standards recommended for inclusion in clinical trials for consideration
of drug and device applications4,14,16
Criteria to consider
in PRO development Comment
Appropriateness • Does content address relevant questions for device or drug?
• Were patients (and their concerns) included in the development of the conceptual framework?
Acceptability • Is the questionnaire acceptable to patients?
• How is it being administered (paper, electronic)?
• Timing after intervention?
• How long does it take?
• Frequency of administration?
• Language?
Feasibility • Is it easy to administer, easy to analyze?
• Cost?
• Staff training?
• Does it interrupt workflow?

Interpretability • Are the scores easy to interpret?
• What is the minimal clinically important difference from the patient perspective?
Precision • How precise are the scores?
• How is it scaled? Visual analog? Likert? Categorical? Weighting?

Reliability • Are the results internally consistent and reproducible (test/re-test)?
Validity • Does the questionnaire measure what it claims to measure?
• Targeted patient population acknowledges face/content validity?
• Criterion validity—correlates with another measure (if there is one)
• Construct validity
Responsiveness • Does it detect changes over time (after treatment) that matter to patients?
• Does it detect differences in disease states?
• What is the minimal clinically meaningful effect or change?

Abbreviation: PRO, patient-reported outcome.
consistently demonstrated improvement in to collect PRO data for cancer patients—

quality of life as measured by the following despite age or severity of illness—and in-
PROs: perception of pain, mobility, physical tegrate it into clinical care delivery. These
functioning, social functioning, and emo- data can provide useful, actionable infor-
tional distress. Because of concerns about mation, resulting in decreased emergency
high volume, high cost, and inconsistent department visits, longer toleration of che-
outcomes, the US Department of Health and motherapy, and improved survival.22 Simi-
Human Services has specified that 50% of lar results have been demonstrated in other
Medicare and 90% of Medicaid reimburse- medical conditions, although challenges ex-
ments will be based on outcomes or value- ist when transitioning from research settings
based purchasing options.21 to routine care. Challenges include privacy
Studies have shown that it is possible concerns, patient recruitment and tracking,
Gregory 0318.indd 21 2/27/18 2:03 PM

encouraging patients to complete the PRO urinary incontinence, and surgery for benign
surveys (nonresponse leads to biased data), gynecology symptoms, as well as for cancer
real and perceived administrative burden to (breast, ovarian, cervical).25–39
staff, obtaining clinician buy in, and costs re- From the PCOS literature we can glean
lated to surveys and data analysis.23 a poignant example of the importance of
PROs. Martin and colleagues compared
patient and clinician interviews regarding
Using PROs in women’s important PROs from the patient perspec-
health care: Benefits for tive.29 Patients identified pain, cramping,
patients and clinicians heavy bleeding, and bloating as important,
According to a study by Frosch, patients want whereas clinicians did not consider these
to know if a prescribed therapy actually im- symptoms important to patients with PCOS.
proves outcomes, not whether it changes an Clinicians thought “issues with menstrua-
isolated biomarker that does not translate tion,” characterized as irregular or no peri-
into subjective improvement.24 They want ods, were important, whereas patients were
to know if the trade-off (adverse effects or more concerned with heavy bleeding or
higher cost) associated with a new drug or bleeding of long duration. The authors con-
therapy is worth the improved mobility or cluded that concepts frequently expressed
time spent pain free. by patients and considered important from
Intuitively, all clinicians have similar their perspective did not register with clini-
opportunities for discussions with regard to cians as being relevant and are not captured
the risks, benefits, and alternatives of medi- on current PRO instruments, emphasizing
cal treatment, surgical treatment, or expect- our knowledge gap and the need to pay at-
FAST ant management. We routinely document tention to what patients want.29
TRACK this discussion daily. However, in this era of Surprisingly, although pregnancy and
patient-centered care, when a patient asks, childbirth is the number one cause for hos-
ObGyns are well “What should I do, doctor?” we no longer pital admissions, a highly preference-driven
suited to benefit can respond with a default recommenda- condition, and a leading cause of morbidity,
from standardized tion. We must engage the patient and ask, mortality, and costs, there are few published
efforts to collect “What do you want to do? What is most im- PROs in the field. In a systematic review of
PROs, as we portant to you?” more than 1,700 articles describing PROs
frequently ObGyns are well suited to benefit from published in English through 2014, Martin
discuss with our standardized efforts to collect PROs, as we found that fewer than 1% included PROs spe-
patients trade- frequently discuss with our patients trade- cific to pregnancy and childbirth.40
offs regarding offs regarding treatment risks and benefits ICHOM has created a standard set of
treatment risks and their personal values and preferences. outcomes for pregnancy and childbirth
and benefits and Examples include contraception options, based on consensus recommendations from
their personal hormone treatment for menopause, medi- physicians, measurement experts, and pa-
values and cation use during pregnancy, decisions at tients.41 The consortium describes 4 domains
preferences the limits of viability, preterm delivery for and 14 subdomains (TABLE 2 ) and provides
severe preeclampsia, induction/augmen- suggestions for a validated PROM if known or
tation versus spontaneous labor, epidural where appropriate.
versus physiologic labor, repeat cesarean Similar domains and subdomains have
versus vaginal birth after cesarean, and even been corroborated by our research team
elective primary cesarean versus vaginal (the Maternal Quality Indicator [MQI] Work
birth. Group), the Childbirth Connection, and Gart-
Validated PROMs exist for benign gyne- ner and colleagues.42–44 The MQI Work Group
cology, such as abnormal uterine bleeding, recently conducted a national survey of what
fibroids, polycystic ovary syndrome (PCOS), women want and what they think is important
infertility, pelvic organ prolapse and/or for their childbirth experience. We identified
Gregory 0318.indd 22 2/27/18 2:03 PM

TABLE 2 ICHOM standard set of outcomes for pregnancy and childbirth41
Patient-reported health Patient satisfaction
Domains Survival Morbidity and well-being with care
Subdomains Maternal Severe maternal Health-related quality of life Satisfaction with results
mortality morbidity of care
Neonatal Neonatal morbidity Postpartum depression Shared decision making and
mortality confidence in care providers
Preterm birth Maternal confidence and Birth experience
success with breastfeeding
Pelvic pain and dysfunction
Mother-infant attachment
Confidence with role as
a mother
Abbreviation: ICHOM, International Consortium for Health Outcomes Measurement.
19 domains, consistent with those of other with care is needed if we are to provide value-
investigators.42 Gartner and colleagues advo- based care in this arena.45
cate for a composite outcome measure that
combines the core domains into one prefer-
ence-based utility measure that is weighted.44 Looking forward
The rationale for this recommendation is that PROs, PROMs, and PREMs are here to stay.
the levels of the domains might contribute They no longer are limited to clinical re-
differently to the overall birth experience. For search, but increasingly will be incorporated FAST
example, communication might contribute into clinical care, providing us with oppor- TRACK
more to an overall measure than pain man- tunities to improve the quality of health care
agement.44 The development of a childbirth- delivery, efficiency of patient/clinician inter- Development of a
specific survey to evaluate patient-reported actions, and patients’ ratings of their health childbirth-specific
outcomes and patient-reported experiences care experience. survey to evaluate
patient-reported
References outcomes and
1. Committee on Quality of Health Care in America, Institute of Serv Insights. 2013;6:61–68.
Medicine. Crossing the quality chasm: a new health system 8. McLeod LD, Coon CD, Martin SA, Fehnel SE, Hays RD.
experiences with
for the 21st century. Washington, DC: National Academy Interpreting patient-reported outcome results: US FDA care is needed if
Press; 2001:6. guidance and emerging methods. Expert Rev Pharmacoecon
2. Stewart M, Brown JB, Donner A, et al. The impact of patient- Outcomes Res. 2011;11(2):163–169.
we are to provide
centered care on outcomes. J Fam Pract. 2000;49(9):796–804. 9. European Medicines Agency, Committee for Medicinal value-based care
3. Rickert J. Patient-centered care: what it means and how to Products for Human Use. Reflection paper on the regulatory
get there. Health Affairs website. http://healthaffairs.org guidance for the use of health-related quality of life (HRQL) in this arena
/blog/2012/01/24/patient-centered-care-what-it-means- measures in the evaluation of medicinal products. https://
and-how-to-get-there/. Published January 24, 2012. Accessed www.ispor.org/workpaper/emea-hrql-guidance.pdf.
October 15, 2017. Published July 27, 2005. Accessed February 7, 2018.
4. US Food and Drug Administration. Guidance for industry: 10. Venkatesan P. New European guidance on patient-reported
Patient reported outcome measures: use in medical product outcomes. Lancet Oncol. 2016;17(6):e226.
development to support labeling claims. https://www 11. Cella D, Yount S, Rothrock N, et al; PROMIS Cooperative
.fda.gov/downloads/drugs/guidances/ucm193282.pdf. Group. The Patient-Reported Outcomes Mesurement
Published December 2009. Accessed February 6, 2018. Information System (PROMIS): progress of an NIH Roadmap
5. Higgins JP, Green S, eds. Cochrane handbook for systematic cooperative group during its first two years. Med Care.
reviews of interventions, version 5.1.0 (updated March 2011). 2007;45(5 suppl 1):S3–S11.
Chichester, UK: John Wiley & Sons; 2008. http://handbook 12. Cella D, Riley W, Stone A, et al; PROMIS Cooperative Group.
.cochrane.org. Accessed October 15, 2017. The Patient-Reported Outcomes Mesurement Information
6. Patrick DL, Guyatt PD, Acquadro C. Patient-reported System (PROMIS) developed and tested its first wave of adult
outcomes. In: Higgins JP, Green S, eds. Cochrane handbook self-reported health outcome item banks: 2005–2008. J Clin
for systematic reviews of interventions, version 5.1.0 (updated Epidemiol. 2010;63(11):1179–1194.
March 2011). Chichester, UK: John Wiley & Sons; 2008:chap 13. Craig BM, Reeve BB, Brown PM, et al. US valuation of health
17. http://handbook-5-1.cochrane.org/. Accessed October outcomes measured using the PROMIS-29. Value Health.
15, 2017. 2014;17(8):846–853.
7. Weldring T, Smith SM. Patient-reported outcomes (PROs) 14. National Institutes of Health. Patient-Reported Outcomes
and patient-reported outcome measures (PROMs). Health Measurement Information System (PROMIS). https:// CONTI NUED ON PAGE 48
Gregory 0318.indd 23 2/27/18 2:03 PM

UPDATE Gynecologic cancer
Jason D. Wright, MD
Dr. Wright is Sol Goldman Associate Professor, Chief of Division of Gynecologic
Oncology, Vice Chair of Academic Affairs, Department of Obstetrics and Gynecology,
Columbia University College of Physicians and Surgeons, New York, New York.
The author reports no financial relationships relevant to this article.
Gynecologic malignancies remain a major cause of

morbidity and mortality. In this article: latest cervical cancer
screening recommendations from the USPSTF, and 2
endometrial cancer news items, on SLN biopsy and PD-1
blockade immunotherapy.
I
n this Update, I report on the latest US study of the accuracy of sentinel lymph node
Preventive Services Task Force (USPSTF) (SLN) biopsy in endometrial cancer, and a
cervical cancer screening recommenda- proof-of-concept review of use of checkpoint
IN THIS tions. In addition, I describe the results of blockade to increase immune response and
ARTICLE 2 studies, a large prospective multicenter of its possible role in endometrial cancer.
Cervical cancer
screening hrHPV testing used alone as primary
page 24
screening for cervical cancer:
SLN biopsy and
endometrial cancer USPSTF recommendations
page 25
US Preventive Services Task Force. Draft recommen- recommendations, which were updated in
Immunotherapy for dation statement: cervical cancer: screening. https:// October 2017.
gyn cancers www.uspreventiveservicestaskforce.org/Page/Docu Even with the widespread implementa-
page 26 ment/draft-recommendation-statement/cervical- tion of screening programs for cervical can-
cancer-screening2. Published October 2017. Accessed cer in the United States, 13,240 women will
February 5, 2018. be diagnosed with the disease in 2018, and
4,170 will die from cervical cancer.1 Most
D
espite our rapid advances in under- often, cervical cancer occurs in women who
standing the molecular under- have not been adequately screened. It is now
pinnings of cancer, gynecologic recognized that the human papillomavirus
malignancies are still a major cause of mor- (HPV) is the cause of cervical cancer.2
bidity and mortality among women. Cervi- While cervical cytology has long been
cal cancer stands as an example of how a used as a screening test for cervical cancer,
cancer screening test can be implemented testing for high-risk HPV subtypes (hrHPV
to reduce mortality. In this section, I report testing) also has been used as a screening
on the USPSTF cervical cancer screening modality. Traditionally, hrHPV testing is used
Update 0318.indd 24 2/27/18 2:04 PM

in combination with cervical cytology, so
called cotesting. There is convincing evidence
WHAT THIS EVIDENCE MEANS FOR PRACTICE
that cervical cytology, as well as strategies
Testing for high-risk HPV alone is a reasonable screening option for
that use hrHPV testing, can detect high-grade cervical cancer. This modality can be used in women 30 to 65 years
cervical precancers and cancers and thereby of age but should not be repeated more frequently than every 5 years
reduce mortality. However, cervical cancer in those with a negative result.
screening is also associated with frequent
follow-ups, invasive procedures performed
to assess abnormal results, psychological increased the number of follow-up tests but
distress, and adverse pregnancy outcomes of did not increase detection of grade 3 CIN or
treatment for precancerous lesions. invasive cancer. This is the first clinical guide-
The USPSTF based its new cervical can- line to recommend hrHPV testing used alone
cer screening recommendations on clinical for screening. The American College of Obste-
trial data and decision modeling of various tricians and Gynecologists (ACOG) continues
screening strategies, and weighed the ben- to recommend cotesting (cytology in combi-
efits and harms of each strategy. nation with hrHPV) as a primary screening
modality in this population.3
Exceptions. According to the USPSTF,
Recommendations from 3 populations should not be screened:
the USPSTF women over 65 years of age with adequate
hrHPV screening for cervical cancer. The prior screening who are not otherwise at
USPSTF recommends screening with cervi- high risk for cervical cancer; women under
cal cytology every 3 years for women 21 to 21 years of age; and women who have had
29 years of age. For women 30 to 65 years of a hysterectomy and do not have a history of FAST
age, screening with cytology every 3 years, grade 2 or 3 CIN or cancer. TRACK
or hrHPV testing alone used every 5 years, is Summary. The USPSTF recommendations
recommended. are intended for the general population and For women
Data from large randomized trials suggest are not applicable to women with a history aged 21 to 29,
cytologic screening is slightly less sensitive of high-grade CIN or cervical cancer, women screening with
than hrHPV testing in detecting high-grade with in utero exposure to diethylstilbestrol, cervical cytology
(grade 2 or 3) cervical intraepithelial neoplasia and women who are immunocompromised. every 3 years is
(CIN). However, hrHPV testing results in more The remaining USPSTF recommendations recommended
follow-up tests and colposcopies. In a deci- are largely in line with guidelines published by the USPSTF.
sion model, the USPSTF found that cotesting by ACOG and other groups.3,4 For women aged
30 to 65, testing
for high-risk HPV
SLN biopsy for staging is a reasonable

screening option to
cervical cytology.
endometrial cancer
Rossi EC, Kowalski LD, Scalici J, et al. A compari- surgical techniques and the introduction of
son of sentinel lymph node biopsy to lymphadenec- less radical procedures for gynecologic can-
tomy for endometrial cancer staging (FIRES trial): a cers have helped reduce surgical morbidity.
multicentre, prospective, cohort study. Lancet Oncol. For endometrial cancer, the role of
2017;18(3):384–392. lymphadenectomy is controversial. Data from
prospective trials of this procedure suggest
S
urgery is the cornerstone of treatment an association with increased morbidity and
for most gynecologic cancers. The long-term sequelae, such as lymphedema,
widespread use of minimally invasive and no association with improved survival.5,6 CONTINUED ON PAGE 26
Update 0318.indd 25 2/27/18 2:04 PM

UPDATE gynecologic cancer
SLN biopsy is an important advance value was high, 99.6%. The procedure was
and a potential alternative nodal evalua- associated with acceptable short-term tox-
tion method that may be associated with icity with adverse events in 9% of study par-
decreased morbidity. In this more limited ticipants. Common complications included
assessment technique, the first nodal drain- neurologic complications, respiratory dis-
age basins of a tumor are identified and tress, nausea and vomiting, and, in 3 patients,
removed for pathologic evaluation. bowel injury.
Accuracy of SLN biopsy in endometrial Accurate detection of nodal metasta-
cancer was the subject of Rossi and col- ses. Results of the study suggest SLN biopsy
leagues’ recent large prospective multicenter is accurate in detecting nodal metastases in
study, the Fluorescence Imaging for Robotic women with endometrial cancer. Although
Endometrial Sentinel lymph node biopsy long-term toxicity was not examined, other
(FIRES) trial. work suggests the lymphedema rates asso-
ciated with SLN biopsy may be lower than
Details of the study those of lymphadenectomy. While the study
Rossi and colleagues conducted the FIRES described impressive performance charac-
trial to estimate the sensitivity of SLN biopsy teristics, there remain technical challenges.
in detecting nodal metastases in women with Even among skilled surgeons trained for
stage I endometrial cancer. Patients (N = 385) the protocol, there was no nodal mapping
from 10 US sites were enrolled in the study. in nearly half of the women with endome-
SLN evaluation was performed after cervical trial cancer. Women without node mapping
injection of indocyanine green followed by require full lymphadenectomy thus negating
robotic-assisted hysterectomy. After identi- the possible benefits of the procedure.
FAST fication of the SLN, participants underwent
TRACK pelvic lymphadenectomy. Performance of WHAT THIS EVIDENCE
para-aortic lymphadenectomy was optional. MEANS FOR PRACTICE
SLN biopsy was Mapping of the SLN was feasible in 86%
97% sensitive in of patients, including bilateral mapping in Given the high accuracy of SLN mapping
detecting nodal 52%. Twelve percent of the participants had in endometrial cancer, the procedure likely
metastases nodal metastases. SLN biopsy had a sensitiv- will become the standard of care for nodal
in women ity of 97% in women who had identification evaluation by gynecologic oncologists.
with stage I of the SLNs. Similarly, the negative predictive
endometrial
cancer, and the
procedure likely
will become Immunotherapy for
standard of
care for nodal gynecologic cancers
evaluation
Le DT, Durham JN, Smith KN, et al. Mismatch repair of clinically used immunotherapeutic agents
deficiency predicts response of solid tumors to PD-1 is blockade of programmed cell death protein
blockade. Science. 2017;357(6349):409–413. 1 (PD-1), a lymphocyte receptor that prevents
the immune system from targeting the body’s
I
n oncology, precision medicine is rapidly own cells.7 Cancers that have mutations in
becoming a standard treatment approach. the DNA mismatch repair (MMR) proteins
Therapies are being used to target spe- display microsatellite instability (MSI) and
cific genetic alterations in tumors. In cancer produce high levels of abnormal proteins.8
immunotherapy, the immune system is being These abnormal proteins serve as tumor anti-
used to facilitate clearance of cancer cells. gens that can be targeted by the body’s normal
The most common mechanism of action immune system.
Update 0318.indd 26 2/27/18 2:04 PM

FIGURE Mismatch-repair deficiency across 12,019 tumors
18
16
14
Percentage of tumors
12
10
6
Late stage Early stage
4
0
l er er er y s r rs
ria
a ie
s a s
or om
a a a a a a a es a
ar ma nce om
a a a
et no
m
nc om nc om om com nom com nom nci nom anc anc om om mo
ci a in ca um cin in cin r i r a i rim ino a in in ast u
om ar gn rc l t
ar rc r s a r c s a e l a n
ig car rian
c c
g
c p rc g
c
ar
c rc l t
En
d c al
i ca ica e
rin r c ca ca e ca al l m al un w
n
ca l lun st c ca liob sue
no l m no erv oc lula no gio rin oid ne ea m eno ova ell l no lial l on G is
e
ad tin a d e C d d e n t e r t o v c t d c k c e e a t i t-t
c la
l
en ce ic a hola U
T hy e ri U t ra ic a l
l
ia all Un ithe all Br junc S of
i s a o o p l e
tr te ct ur at ta
t C r ta reat th Sm ep –sm c
as in re Ne ep ros lo ni pi e tri
G all o lo H ea ge anc one f ac Non as
P n e r g
Sm C
rit
o al P N su go
pe f em i an p ha
o r o
tr er va es
Re th O
O
a nd
l
ea
h ag
op
Es
Percentage of tumors deficient in mismatch repair in each cancer subtype. Deficient tumors were identified in 24 of 32 subtypes
tested, more often in early disease (pre–stage IV).
SOURCE: Le DT, Durham JN, Smith KN, et al. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017;357(6349):409–413. Used with
permission.
In May 2017, the US Food and Drug Details of the study

Administration (FDA) granted accelerated This study examined the clinical efficacy of
approval of the PD-1 blocking antibody pem- PD-1 blockade in 86 patients with advanced,
brolizumab for the treatment of unresectable MMR-deficient tumors from 12 different
or metastatic MSI-high (MSI-H) or MMR- sites. Endometrial cancer was the second
deficient solid tumors.9 The approval was most frequent primary tumor site in 17% of
based on data from 149 patients treated in patients. Within the cohort, the overall objec-
5 studies that demonstrated a response rate tive response rate was 53%, which included
of 39.6%, including responses that lasted at 21% of patients with complete radiographic
least 6 months in 78% of participants. This was response (no imaging evidence of cancer).
the first ever cancer drug that received FDA Disease control, either complete or partial
approval based on a tumor’s biomarker profile response or stable disease, was achieved in
without regard to the site of origin. I describe 77% of patients. After a median follow-up of
the results of a study by Le and colleagues 12.5 months, neither the median progression-
that examines the possible role of immu- free survival (PFS) nor median overall sur-
notherapy in a variety of solid tumors in vival had been reached. The authors esti-
this section. mated that 2-year overall survival was 64%,
Update 0318.indd 27 2/27/18 2:04 PM

UPDATE gynecologic cancer
substantially higher than expected for

patients with advanced solid tumors.
WHAT THIS EVIDENCE
MEANS FOR PRACTICE
Le and colleagues also performed
several in vivo laboratory experiments Immunotherapy with PD-1 blockade is an
to explore the mechanisms by which important treatment strategy for women
patients responded. In addition, they used with MMR-deficient or MSI-H gynecologic
sequencing to determine the prevalence cancers.
of MMR deficiency in 12,019 cancer sam-
ples that included 32 distinct tumor types
(FIGURE, page 27). Endometrial cancer had women with endometrial cancer. For women
the highest frequency of MMR deficiency with positive test results, germline sequenc-
(17%). Four percent of cervical cancers ing can be performed to determine if they
and less than 2% of ovarian cancers were have an inherited MMR deficiency, Lynch
MMR-deficient. syndrome. Presence of an MMR deficiency is
The promise of immunotherapy for an important factor in cancer screening and
endometrial cancer. This study’s data and potential treatment.
other emerging data have important impli- Second, the impressive results of PD-1
cations for women with gynecologic cancer, blockade in patients with MMR-deficient
particularly endometrial cancer. First, given tumors suggest that this treatment strategy
the frequency of MMR mutations among may be important for women with recurrent
women with endometrial cancer, MMR test- or metastatic endometrial cancer. The ideal
ing should be strongly considered for these timing of immunotherapy for women with
patients. Many institutions have protocols for endometrial cancer is an area of active ongo-
FAST reflex testing with immunohistochemistry for ing study.
TRACK
References
Given the 1. American Cancer Society. Cancer Facts & Figures 2018. pelvic lymphadenectomy vs. no lymphadenectomy in early-
Atlanta, GA: American Cancer Society; 2018. stage endometrial carcinoma: randomized clinical trial. J Natl
frequency of 2. Walboomers JM, Jacobs MV, Manos MM, et al. Human pap- Cancer Inst. 2008;100(23):1707–1716.
MMR mutations illomavirus is a necessary cause of invasive cervical cancer 6. ASTEC Study Group, Kitchener H, Swart AM, Qian Q, Amos C,
worldwide. J Pathol. 1999;189(1):12–19. Parmar MK. Efficacy of systematic pelvic lymphadenectomy
among women 3. American College of Obstetricians and Gynecologists Com- in endometrial cancer (MRC ASTEC trial): a randomised
with endometrial mittee on Practice Bulletins-Gynecology. ACOG Practice study. Lancet. 2009;373(9658):125–136.
Bulletin No. 168: Cervical cancer screening and prevention. 7. Pardoll DM. The blockade of immune checkpoints in cancer
cancer, MMR Obstet Gynecol. 2016;128(4):e111–e130. immunotherapy. Nat Rev Cancer. 2012;12(4):252–264.
testing should 4. Saslow D, Solomon D, Lawson HW, et al; ACS-ASCCP-ASCP 8. Buza N, Ziai J, Hui P. Mismatch repair deficiency testing in
Cervical Cancer Guideline Committee. American Can- clinical practice. Expert Rev Mol Diagn. 2016;16(5):591–604.
be strongly cer Society, American Society for Colposcopy and Cervi- 9. FDA approves first cancer treatment for any solid tumor with
considered for cal Pathology, and American Society for Clinical Pathology a specific genetic feature [news release]. Silver Spring, MD: US
screening guidelines for the prevention and early detection of Food and Drug Administration. https://www.fda.gov/news
these patients cervical cancer. CA Cancer J Clin. 2012;62(3):147–172. events/newsroom/pressannouncements/ucm560167.htm.
5. Benedetti Panici P, Basile S, Maneschi F, et al. Systematic Published May 23, 2017. Accessed February 5, 2018.
Did you read these related articles?

The beginning of the end Is sentinel lymph node Does laparoscopic versus open
of the Pap? mapping associated with abdominal surgery for stage I
Mark H. Einstein, MD, MS acceptable performance endometrial cancer affect
(Examining the Evidence; characteristics for the oncologic outcomes?
February 2018) detection of nodal metastases Kathryn A. Mills, MD,
in women with endometrial and David G. Mutch, MD
2017 Update on cancer? (Examining the Evidence; June 2017)
cervical disease Jason D. Wright, MD
Mark H. Einstein, MD, MS (May 2017) (Examining the Evidence; July 2017)
Update 0318.indd 28 2/27/18 2:04 PM

9 CY, & LACTATIO
N:
DRUGS, PREGNAN enza
7 bers discusses influ
use is low among Dr. Christina D. Cham y.
CONTRACEPTION in preg nanc
6 ly five times more teenaged girls on
teratogenic drug
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vacc inati on
FIBROIDS are near icaid claims data
rican women according to Med loping diabetes.
likely in African Ame reduce risk of deve 2018
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Gynecologic Surgeons
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cystic ovary synd embryos does not lead agues reported , ired.
China, and colle Medicine. The live birth rate as long as requ d Kirsten Sasaki, MD, to
of frozen vs. fresh er live birth or ongoing Jour nal of at 28 wee ks aske
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Factors critical to reducing
US maternal mortality and morbidity
ACOG is working to eliminate preventable maternal mortality with an all-
hands-on-deck approach through its AIM Program and other collaborative
initiatives with clinicians, public health officials, hospitals, and patient safety
organizations
Lucia DiVenere, MA
M
ore women die from pregnancy mortality rate (unadjusted) in only 15 years:
complications in the United States from 18.8 deaths per 100,000 live births in 2000
than in any other developed coun- to 23.8 in 2014 (FIGURE 1, page 32).1
IN THIS try. The United States is the only industrial- This problem received federal attention
ARTICLE ized nation with a rising maternal mortality when, in 2000, the US Department of Health
rate. and Human Services launched Healthy Peo-
Disparities in Those 2 sentences should stop us all in ple 2010. That health promotion and disease
maternal mortality our tracks. prevention agenda set a goal of reducing ma-
In fact, the United States ranks 47th ternal mortality to 3.3 deaths per 100,000 live
page 30
globally with the worst maternal mortality births by 2010, a goal clearly not met.
rate. More than half these deaths are likely
AIM Program preventable, with suicide and drug overdose
page 31 the leading causes of maternal death in many Considerable variations by race
states. All this occurs despite our advanced and by state
Maternal mortality medical system, premier medical colleges The racial disparities in maternal mortal-
statistics and universities, embrace of high-tech medi- ity are staggering and have not improved
page 32 cal advances, and high percentage of gross in more than 20 years: African American
domestic product spent on health care. women are 3.4 times more likely to die than
Need more numbers? According to a 2016 non-Hispanic white women of pregnancy-
report in Obstetrics and Gynecology, the United related complications. In 2011–2013, the ma-
States saw a 26% increase in the maternal ternal mortality ratio for non-Hispanic white
women was 12.7 deaths per 100,000 live
births compared with 43.5 deaths for non-
Ms. DiVenere is Officer, Government and
Political Affairs, at the American College Hispanic black women (FIGURE 2, page 32).2
of Obstetricians and Gynecologists American Indian or Alaska Native women,
in Washington, DC. She is an
OBG ManaGeMent Contributing Editor.
Asian women, and some Latina women also
experience higher rates than non-Hispanic
white women. The rate for American Indian
The author reports no financial relationships relevant to this or Alaska Native women is 16.9 deaths per
article. 100,000 live births.3
DiVenere 0318.indd 30 2/27/18 2:05 PM

Some states are doing better than oth- • create and encourage use of maternal
ers, showing that there is nothing inevitable safety bundles (evidence-based tool kits to
about the maternal mortality crisis. Texas, for guide the best care).
example, has seen the highest rate of mater- AIM offers participating physicians and
nal mortality increase. Its rate doubled from hospitals online learning modules, check-
2010 to 2012, while California reduced its lists, work plans, and links to tool kits and
maternal death rate by 30%, from 21.5 to 15.1, published resources. Implementation data
during roughly the same period.1 is shared with hospitals and states to fur-
This is a challenge of epic proportions, ther improve care. Physicians participating
and one that the American College of Obste- in AIM can receive Part IV maintenance of
tricians and Gynecologists (ACOG), under certification; continuing education units will
the leadership of President Haywood Brown, soon be offered for nurses. In the future, AIM-
MD, and Incoming President Lisa Hollier, participating hospitals may be able to receive
MD, is determined to meet, ensuring that a reduced liability protection costs, too.
high maternal death rate does not become To date, 17 states are participating in
our nation’s new normal. the AIM initiative (FIGURE 3, page 32), with
Dr. Brown put it this way, “ACOG col- more states ready to enroll.4 States must dem-
laborative initiatives such as Levels of Mater- onstrate a commitment to lasting change to
nal Care (LOMC) and implementation of OB participate. Each AIM state must have an
safety bundles for hemorrhage, hyperten- active maternal mortality review committee
sion, and thromboembolism through the AIM (MMRC); committed leadership from public
[Alliance for Innovation on Maternal Health] health, hospital associations, and provider
Program target maternal morbidity and mor- associations; and a commitment to report
tality at the community level. Bundles have AIM data. FAST
also been developed to address the disparity AIM thus far has released 9 obstetric pa- TRACK
in maternal mortality and for the opiate crisis.” tient safety bundles, including:
ACOG is making strides in putting in • reducing disparities in maternity care AIM offers
place nationwide meaningful, evidence- • severe hypertension in pregnancy participating
driven systems and care approaches that • safe reduction of primary cesarean birth physicians and
are proven to reduce maternal mortality and • prevention of venous thromboembolism hospitals online
morbidity, saving mothers’ lives and keeping • obstetric hemorrhage learning modules,
families whole. • maternal mental health checklists,
• patient, family, and staff support following work plans, and
a severe maternal event links to tool kits
ACOG’s AIM Program • postpartum care basics and published
established to make an impact • obstetric care of women with opioid use resources
The AIM Program (www.safehealthcare disorder (in use by Illinois, Massachusetts,
foreverywoman.org) is bringing together Maryland, New Jersey, Maine, New Hamp-
clinicians, public health officials, hospital shire, Vermont, New York, Ohio, Okla-
administrators, patient safety organizations, homa, Tennessee, Texas, and Virginia).
and advocates to eliminate preventable
maternal mortality throughout the United
States. With funding and support from the US Review committees are critical
Health Resources and Services Administra- to success
tion, AIM is striving to: In use in many states, MMRCs are groups of
• reduce maternal mortality by 1,000 deaths local ObGyns, nurses, social workers, and
by 2018 other health care professionals who review
• reduce severe maternal morbidity specific cases of maternal deaths from their
• assist states and hospitals to improve out- local area and recommend local solutions
comes to prevent future deaths. MMRCs can be a
DiVenere 0318.indd 31 2/27/18 2:05 PM

Reducing US maternal mortality and morbidity
Adjusted US maternal
FIGURE 1 US maternal mortality ratio
FIGURE 2
mortality rates, 2000–20141 by race, 2011–20132
Maternal deaths per 100,000 live births

35
Black 43.5
30
Rate per 100,000 live births
25
22.8
20
Slope=0.33
18.2
15 Other races 14.4
10
5
White 12.7
0
2000 2005 2010 2014
Year
FIGURE 3States, hospital networks, and other countries currently participating

in the AIM Program4
AIM states AIM networks AIM countries
California Maryland North Carolina Texas National Perinatal Information Center Malawi
Florida Michigan Oklahoma Utah Premier Northern Mariana Islands
Georgia Mississippi South Carolina Virginia Trinity Health Care
Illinois New Jersey Tennessee West Virginia
Louisiana
Current AIM states

WA
MT NH ME
ND VT
OR MN Invited opioid non-AIM states
ID
MA
SD WI NY
WY MI
RI Serious intent
NV NE IA PA CT
NJ
IL OH DE
CA UT CO IN Interested
WV MD
KS MO VA DC
KY
NC
AZ Puerto Rico Guam Northern
NM OK TN
AR SC Mariana
Islands
MS AL GA
TX LA
AK FL
American Samoa United States
Virgin Islands
HI
Abbreviation: AIM, Alliance for Innovation on Maternal Health.
DiVenere 0318.indd 32 2/27/18 2:05 PM

critically important source of data to help us maternal death. The detailed state-based ma-
understand the underlying causes of mater- ternal mortality reviews provide critical in-
nal mortality. formation: verification of vital statistics data,
Remember California’s success in reduc- assessment of the causes and contributing
ing its maternal mortality rate, previously factors, and determination of pregnancy re-
mentioned? That state was an early adopter latedness. These reviews identify opportuni-
of an active MMRC and has worked to bring ties for prevention and implementation of
best practices to maternity care throughout the the most appropriate interventions to reduce
state. maternal mortality on a local level. Support of
While every state should have an active essential review functions at the federal level
MMRC, not every state does. ACOG is work- would also enable data to be combined across
ing with states, local leaders, and state and jurisdictions for national learning that was
federal legislatures to help develop MMRCs previously not possible.”
in every state.
Dr. Brown pointed out that, “For several
decades, Indiana had a legislatively autho- Pending legislation will
rized multidisciplinary maternal mortality strengthen efforts
review committee that I actively participated ACOG is working to enact into law the Prevent-
in and led in the late 1990s. The authorization ing Maternal Deaths Act, HR 1318 and S1112.
for the program lapsed in the early 2000s, and This is bipartisan legislation under which the
the Indiana MMRC had to shut down. Bol- Centers for Disease Control and Prevention
stering the federal government’s capacity to would help states create or expand MMRCs
help states like Indiana rebuild MMRCs, or and will require the Department of Health and
start them from scratch, will help state public Human Services to research ways to reduce FAST
health officials, hospitals, and physicians take disparities in maternal health outcomes. TRACK
better care of moms and babies.”
Dr. Hollier explained, “In Texas, I chair Acknowledgement ACOG is working
our Maternal Mortality and Morbidity Task The author thanks Jean Mahoney, ACOG’s with states, local
Force, which was legislatively authorized Senior Director, AIM, for her generous leaders, and
in 2013 in response to the rising rate of assistance. state and federal
legislatures to help
References develop MMRCs in
1. MacDorman MF, Declerq E, Cabral H, Morton C. Recent Publication. Health Resources and Services
increases in the US maternal mortality rate: disentangling Administration, Maternal and Child Health Bureau.
every state
trends from measurement issues. Obstet Gynecol. Rockville, Maryland: US Department of Health and Human
2016;128(3):447–455. Services; 2010. https://www.hrsa.gov/sites/default/files
2. Centers for Disease Control and Prevention. Pregnancy /ourstories/mchb75th/mchb75maternalmortality.pdf.
mortality surveillance system. www.cdc.gov/reproductive Accessed February 16, 2018.
health/maternalinfanthealth/pmss.html. Updated November 4. Council on Patient Safety in Women’s Health Care. Alliance
9, 2017. Accessed February 16, 2018. for Innovation on Maternal Health Program: AIM states
3. Singh GK. Maternal mortality in the United States, and systems. http://safehealthcareforeverywoman.org
1935−2007: Substantial racial/ethnic, socioeconomic, /aim-states-systems-2/#link_tab-1513011413196-9. Accessed
and geographic disparities persist. A 75th Anniversary February 20, 2018.
Watch for these upcoming articles:

Tackling opioids and maternal health in US Congress
Lucia DiVenere, MA, with US Representative Phil Roe, MD
Trends in the use of value-based payment in health care:

The current climate in Washington
Lucia DiVenere, MA
DiVenere 0318.indd 33 2/27/18 2:05 PM

ILLUSTRATION: KIMBERLY MARTENS FOR OBG MANAGEMENT
Endometriosis involving the bowel or bladder

often requires subspecialty colleagues, such as
colorectal surgeons and urologists, to be involved
in patient counseling and care.
Roundtable 0318.indd 34 2/27/18 2:06 PM

ROUNDTABLE
Endometriosis: Expert perspectives

on medical and surgical management
Challenging to manage, endometriosis requires a thorough
understanding of the disease process, first- and second-line
therapies, and multidisciplinary care
Expert panel featuring Arnold P. Advincula, MD; Douglas N. Brown, MD;

and Hye-Chun Hur, MD, MPH
E
ndometriosis is one of the more daunt-
ing diagnoses that gynecologists treat. Take-home points
In this roundtable discussion, moder-
ated by OBG Management Board Member • Endometriosis management involves
fluidity of care. Treatment approaches will
Arnold P. Advincula, MD, 2 leading surgeons
change throughout a patient’s reproductive IN THIS
discuss endometriosis diagnosis as well as life, depending on the patient’s presenting ARTICLE
medical and surgical management. symptoms and reproductive goals.
• Inform the patient of the disease process and
Endometrioma
how it may affect her menstrual pain symptoms
and family planning. management
First-time evaluation • Educate patients so they may effectively page 36
Arnold P. Advincula, MD: When a patient participate in the management discussion. Hear
presents to your practice for the first time and the voice of the patient to make a tailored plan
you suspect endometriosis, what consider- of care for each individual. FDA-approved
• Endometriosis can be a complex medical drug treatments
ations tailor your evaluation, and what does problem. Use a comprehensive multidisciplinary
that evaluation involve? approach when appropriate. page 37
Hye-Chun Hur, MD, MPH: The diagnosis is
contingent on a patient’s presenting profile. Endometriosis
How symptomatic is she? How old is she? What what her goals are), I think treating with a first- involving
are her reproductive goals? The gold standard line therapy—hormonal treatments such as the bowel
for diagnosis is a histologic diagnosis, which is progestin-only oral contraceptive pills—is page 38
surgical. Depending on the age profile, how- acceptable. I usually conduct a treatment
ever, and how close she is to menopause, the trial period of 3 to 6 months to see if she ob-
patient may be managed medically. Even tains any symptom relief.
women in the young reproductive age group If that first-line treatment fails, generally
may be managed medically if symptoms are you can move to a second-line treatment.
responsive to medical treatment. I have a discussion in which I either offer
Douglas N. Brown, MD: I agree. When a a second-line treatment, such as medroxy-
patient presents without a laparoscopy, or a progesterone (Depo-Provera) or leuprolide
tissue diagnosis, but the symptoms are con- acetate (Lupron Depot), or get a tissue diag-
sistent with likely endometriosis (depending nosis, if possible, by performing laparoscopy.
on where she is in her reproductive cycle and If first-line or even second-line therapy fails, CONTINUED ON PAGE 36

Endometriosis: Expert perspectives on medical and surgical management
therapy, but if you find uterosacral ligament

OBG Management Expert Panel nodularity, extreme pain on examination,
and suspicious findings on ultrasound or
Arnold P. Advincula, MD otherwise, a diagnostic laparoscopy may be
Levine Family Professor of Women’s Health warranted to confirm the diagnosis.
Vice-Chair, Department of Obstetrics & Gynecology
Chief of Gynecology, Sloane Hospital for Women
Medical Director, Mary & Michael Jaharis Simulation Center
Columbia University Medical Center Endometrioma management
New York-Presbyterian Hospital, New York, New York Dr. Advincula: Let’s jump ahead. You have
decided to proceed with laparoscopy and
Douglas N. Brown, MD
you encounter an endometrioma. What is
Chief, Minimally Invasive Gynecologic Surgery
Director, Center for Minimally Invasive Gynecologic Surgery your management strategy, particularly in a
Vincent Department of Obstetrics & Gynecology fertility-desiring patient?
Massachusetts General Hospital Dr. Hur: Even if a woman has not undergone
Assistant Professor of Obstetrics, Gynecology, and
first-line medical treatment, if she is trying to
Reproductive Biology
Harvard Medical School, Boston, Massachusetts conceive or presents with infertility, it’s a dif-
ferent balancing act for approaching the pa-
Hye-Chun Hur, MD, MPH tient. When a woman presents, either with an
Director, Division of Minimally Invasive Gynecologic Surgery ultrasound finding or an intraoperative find-
Beth Israel Deaconess Medical Center
Assistant Professor, Obstetrics, Gynecology, and
ing of an endometrioma, I am a strong advo-
Reproductive Biology cate of treating symptomatic disease, which
Harvard Medical School means complete cyst excision. Good clinical
data suggest that reproductive outcomes are
Dr. Advincula reports being a consultant to AbbVie, Applied Medical, ConMed, CooperSurgi- improved for spontaneous pregnancy rates
cal, Intuitive Surgical, and Titan Medical and receiving royalties from CooperSurgical. Dr. Brown
reports being a consultant to Medtronic and CooperSurgical. Dr. Hur reports no financial relation- when you excise an endometrioma.3-6
ships relevant to this article. Dr. Advincula: What are the risks of excision
of an endometrioma cyst that patients need
to know about?
you need to consider doing a diagnostic lapa- Dr. Brown: Current standard of care is cys-
roscopy to confirm or deny the diagnosis. tectomy, stripping the cyst wall away from the
Dr. Advincula: Are there any points in the ovarian cortex. There is some concern that
evaluation of a patient who visits your prac- the stripping process, depending on how long
tice for the first time where you would imme- the endometrioma has been present within
diately offer a surgical approach, as opposed the ovary, can cause some destruction to the
to starting with medical management? underlying oocytes and perhaps impact that
Dr. Hur: A large percentage of my patients ovary’s ability to produce viable eggs.
undergo surgical evaluation, as surgical diag- Some studies, from France in particular,
nosis is the gold standard. If you look at the have investigated different energy sources,
literature, even among surgeons, the accu- such as plasma energy, that make it possible to
racy of visual diagnosis is not great.1,2 I target remove part of the cyst and then use the plasma
individuals who are either not responsive to energy to vaporize the rest of the cyst wall that
medical treatment or who have never tried may be lying on the cortex. Researchers looked
medical treatment but are trying to conceive, at anti-Müllerian hormone levels, and there
so they are not medical candidates, or indi- does seem to be a difference in terms of how
viduals who genuinely want a diagnosis for you remove the cyst.7-9 This energy source is not
surgical management—sometimes even be- available to everyone; it’s similar to laser but
fore first-line medical treatment. does not have as much penetration. Standard
Dr. Brown: Your examination sometimes of care is still ovarian stripping.
also dictates your approach. A patient may The conversation with the patient—if she
never have had a laparoscopy or hormone is already infertile and this cyst is a problem—

TABLE US Food and Drug Administration–approved drug classes
for endometriosis treatment
Class Drug Adverse effects
Androgenic steroids • Danazol Hair loss, weight gain, acne, hirsutism
Estrogen-progestin • Monophasic estrogen-progestin Breakthrough bleeding, breast tenderness, nausea, headaches,
combinations mood changes
Gonadotropin-releasing • Goserelin Decreased bone density, atrophic vaginitis, hot flashes,
hormone agonists headache, joint pain
• Leuprolide depot
• Nafarelin
Progestins • Depo-Provera Acne, weight gain, mood changes, headache, breakthrough
bleeding, breast tenderness, lipid abnormalities (norethindrone)
• Norethindrone acetate
Source: Falcone T, Flyckt R. Clinical management of endometriosis [published online ahead of print February 5, 2018]. Obstet Gynecol. doi:10.1097/AOG.0000000000002469.
would be that it likely needs to be removed. than 4 cm, some data suggest that patient
There is a chance that she may need assisted might be better served in a conservative fash-
reproduction; she might not be able to get ion.6,15–17 Then, once she is done with assisted
pregnant on her own due either to the pres- reproduction, we might be more aggressive
ence of the endometrioma or to the surgical surgically by treating the finding that would
process of removing it and stripping. not resolve spontaneously without surgical
Dr. Advincula: How soon after surgery can a management. It is important to highlight that
patient start to pursue trying to get pregnant? endometriomas do not resolve on their own; “If the patient is not
Dr. Hur: I think there is no time restraint out- they require surgical management. symptomatic and she is
side of recovery. As long as the patient has a older with bilateral
routine postoperative course, she can try to endometriomas less
conceive, spontaneously or with assisted re- Endometriosis management for than 4 cm, some data
production. Some data suggest, however, that the patient not seeking fertility suggest that patient
ovarian reserve is diminished immediately Dr. Advincula: Let’s now consider a pa- might be better served in
after surgery.10–12 If you look at the spontane- tient on whom you have performed laparos- a conservative fashion.”
ous clinical pregnancy outcomes, they are copy not only to diagnose and confirm the —Hye-Chun Hur, MD, MPH
comparable 3 to 6 months postsurgery.4,12–14 evidence of endometriosis but also to treat
Dr. Brown: I agree. Time is of the essence endometriosis, an endometrioma, and po-
with a lot of patients, many of whom present tentially deeply infiltrative disease. But this
after age 35. person is not trying to get pregnant. Postop-
Dr. Hur: It’s also important to highlight that eratively, what is your approach?
there are 2 presentations with endometrioma: Dr. Brown: Suppressive therapy for this
the symptomatic patient and the asymptom- patient could be first-line or second-line
atic patient. In the asymptomatic patient, her therapy, such as a Lupron Depot or Depo-
age, reproductive goals, and the bilaterality Provera. We keep the patient on suppressive
(whether it is present on both sides or on one therapy (whatever treatments work for her),
side) of the endometrioma are important in until she’s ready to get pregnant; then we take
deciding on a patient-centered surgical plan. her off. Hopefully she gets pregnant. After she
For someone with a smaller cyst, unilateral delivers, we reinitiate suppressive therapy. I
presentation, and maybe older age at presen- will follow these women throughout their re-
tation, it may or may not impact assisted reproductive cycle, and I think having a team of
productive outcomes. physicians who are all on the same page can
If the patient is not symptomatic and she help this patient manage her disease through
is older with bilateral endometriomas less her reproductive years.

manifestations, including negative impact on

Surgical technique: Excision versus ablation bone and cardiac health.
Hye-Chun Hur, MD, MPH: I am a strong advocate of excision of endometriosis.

I believe that it’s essential to excise for 2 very important reasons. One reason The role of the LNG-IUD
is for diagnosis. Accurately diagnosing endometriosis through visualization
alone is poor, even among gynecologic surgeons. It is very important to have an Dr. Advincula: Something that often comes
accurate diagnosis of endometriosis, since the diagnosis will then dictate the up is the role of a levonorgestrel-releasing in-
treatment for the rest of a patient’s reproductive life. trauterine device (LNG-IUD) as one therapy
The second reason that excision is essential is because you just do not option, either preoperatively or postopera-
know how much disease there is “behind the scenes.” When you start to
excise, you begin to appreciate the depth of the disease, and often fibrosis tively. What is your perspective?
or inflammation is present even behind the endometriosis implant that is Dr. Hur: I reserve the LNG-IUD as a second-
visualized. line therapy for patients, predominantly
Douglas N. Brown, MD: I approach endometriosis in the same way that because it allows direct delivery of the medi-
an oncologist would approach cancer. I call it cytoreduction—reducing the
disease. There is this iceberg phenomenon, where the tip of the iceberg is cation to the womb (rather than systemic ex-
seen in the water, but you have no idea how deep it actually goes. That is very posure of the medication). For patients who
much deep, infiltrative endometriosis. Performing an ablation on the top does experience adverse effects due to systemic
almost nothing for the patient and may actually complicate the situation by exposure to first-line treatments, it might be
causing scar tissue. If a patient has symptoms, I firmly believe that you must
resect the disease, whether it is on the peritoneum, bladder, bowel, or near a great option. However, I do not believe that
the ureter. Now, these are radical surgeries, and not every patient should have it consistently suppresses the ovaries, which
a radical surgery. It is very much based on the patient’s pain complaints and we understand feeds the pathology of the
issues at that time, but excision of endometriosis really, in my opinion, should hormonal stimulation, and so typically I will
be the standard of care.
reserve it as a second-line treatment.
Risks of excision of endometriosis Dr. Brown: I utilize the LNG-IUD in a similar
Dr. Brown: The risks of disease excision depend on whether a patient has fashion. I may have patients who have had a
ureteral disease, bladder disease, or bowel disease, suggested through a
diagnostic laparoscopy somewhere else and
preoperative or another operative report or imaging. If this is the case, we
have a preoperative discussion with the patient about, “To what extent do you were referred to me because they now have
want me to go to remove the disease from your pelvis? If I remove it from your known stage 3 or 4 endometriosis without
peritoneum and your bladder, there is the chance that you’ll have to go home endometriomas. Those patients, if they are
with a Foley catheter for a few days. If the bowel is involved, do you want me
going to need suppressive therapy after sur-
to try to resect the disease or shave it off the bowel? If we get into a problem,
are you okay with me resecting that bowel?” These are the issues that we gery and are not ready to get pregnant, do
have to discuss, because there are potential complications, although known. very well with the LNG-IUD, and I will place it
during surgery under anesthesia. If a patient
has endometriomas seen at the time of sur-
Dr. Hur: If a patient presented warranting surgery, we could still place an LNG-IUD at the
gical management once, and she is not meno- time of surgery. We may need to add on an
pausal, the likelihood that disease will recur additional medication, however, like another
is quite high. Understanding the nature and oral progesterone. I do have patients that use
the pathology of the disease, hormonal sup- both an IUD and either combined oral con-
pression would be warranted. Suppression is traceptive pills and/or oral progestins. Those
not just for between pregnancies, it’s until the patients usually have complicated cases with
patient reaches natural menopause. It’s also very deep infiltrative disease.
in the hopes of suppressing the disease so she
does not need recurrent surgeries.
We typically do not operate unless pa- Managing endometriosis
tients have recurrence of symptoms that no involving the bowel
longer respond to medical therapy. Our hope Dr. Advincula: Patients often are quite con-
is to buy them more time closer to the age of cerned when the words “endometriosis” and
natural menopause so that medical repercus- “bowel” come together. How do you manage
sions do not result in hysterectomy and ovary disease that involves the bowel?
removal, which have other nongynecologic Dr. Hur: A lot of patients with endometriosis

have what I call neighboring disease—it’s not
limited just to the pelvis, but it involves the Watch the full videotaped
neighboring organs including the bowel and roundtable discussion,
bladder. Patients can present with symptoms
related to those adjacent organs. However,
including the experts’ perspectives on aromatase
not all disease involving the bowel or bladder
inhibitor use, at mdedge.com/obgmanagement.
manifests with symptoms, and patients with
symptoms may not have visible disease.
Typically, when a patient presents with
symptoms of bowel involvement, where the
bowel lumen is narrowed to more than 50%
and/or she has functional manifestations
(signs of obstruction that result in abnormal
bowel function), we have serious conver- Use this QR code* to view the video at mdedge.com/obgmanagement
sations about a bowel resection. If she has *Free QR readers are available for smartphones at the iPhone App Store,
Android Market, and BlackBerry App World.
full-thickness disease without significant
bowel dysfunction—other than blood in
her stool—sometimes we talk about more is fluid. It will change during the patient’s
conservative treatment because of the long- reproductive years, and you need to man-
term manifestations that a bowel resection age it accordingly based on her symptoms.
could have. Sometimes the diagnosis is not made for
Dr. Brown: I agree completely. It is important 5 to 10 years, and that can lead to other is-
to have a good relationship with our colorec- sues: depression, fibromyalgia, or irritable
tal surgeons. If I suspect that the patient has bowel syndrome.
“Having specialists such
narrowing of the lumen of the large bowel or The patient may have multiple issues as gastroenterologists
she actually has symptoms such as bloody plus endometriosis. I think having specialists and behavioral therapists
diarrhea during menstruation—which is sug- such as gastroenterologists and behavioral on board, as well as
gestive of deep, infiltrative and penetrative therapists on board, as well as colorectal and colorectal and urological
disease—I will often order a colonoscopy urological surgeons who can perform these surgeons who can
ahead of time to get confirmed biopsies. Then complex surgeries, is very beneficial to the perform these complex
the patient discussion occurs with our colorec- patient. That way, she benefits from the team’s surgeries, is very
tal surgeon, who operates with me jointly if we focus and is cared for from start to finish. beneficial to the patient.
decide to proceed with a bowel resection. It’s Dr. Hur: I like to call the abdomen a studio. That way, she benefits
important to have subspecialty colleagues in- It does not have separate compartments for from the team’s focus
volved in this care, because a low anterior re- each organ system. It’s one big room, and and is cared for from
section is a very big surgery and there can be often the neighboring organs are involved, start to finish.”
down-the-stream complications. including the bowel and bladder. I think —Douglas N. Brown, MD
Dr. Brown’s observation—the multidisci-
plinary approach to a patient’s compre-
The importance of hensive care—is critical. Like any surgery,
multidisciplinary care preoperative planning and preoperative as-
Dr. Advincula: What are your perspectives sessment are essential, and these steps should
on a multidisciplinary or interdisciplinary include the patient. The discussion should
approach to the patient with endometriosis? cover not only the surgical outcomes that
Dr. Brown: As I previously mentioned, it is the surgeons expect, but also what the pa-
important to develop a good relationship tient expects to be improved. For example,
with colorectal surgery/urology. In addi- for patients with extensive disease and bowel
tion, behavioral therapists may be involved involvement, a bowel resection is not al-
in the care of patients with endometriosis, ways the right approach because it can have
for a number of reasons. The disease process potential long-term sequelae. Balancing the

risks associated with surgery with the long- cated disease state, does require a multidisci-
term benefits is an important part of the dis- plinary approach to management, and there
cussion. are implications and strategies that involve
Dr. Advincula: Those are both excellent both the medical approach to management
perspectives. Endometriosis is a very compli- and the surgical approach.
References
1. Wykes CB, Clark TJ, Khan KS. Accuracy of laparoscopy in the M. Compared with cystectomy, is ovarian vaporization of
diagnosis of endometriosis: a systematic quantitative review. endometriotic cysts truly more effective in maintaining
BJOG. 2004;111(11):1204–1212. ovarian reserve? J Minim Invasive Gynecol. 2014;21(5):804–
2. Fernando S, Soh PQ, Cooper M, et al. Reliability of visual 810.
diagnosis of endometriosis. J Minim Invasive Gynecol. 11. Giampaolino P, Bifulco G, Di Spiezio Sardo A, Mercorio A,
2013;20(6):783–789. Bruzzese D, Di Carlo C. Endometrioma size is a relevant
3. Alborzi S, Momtahan M, Parsanezhad ME, Dehbashi S, factor in selection of the most appropriate surgical technique:
Zolghadri J, Alborzi S. A prospective, randomized study a prospective randomized preliminary study. Eur J Obstet
comparing laparoscopic ovarian cystectomy versus Gynecol Reprod Biol. 2015;195:88–93.
fenestration and coagulation in patients with endometriomas. 12. Chang HJ, Han SH, Lee JR, et al. Impact of laparoscopic
Fertil Steril. 2004;82(6):1633–1637. cystectomy on ovarian reserve: serial changes of serum anti-
4. Beretta P, Franchi M, Ghezzi F, Busacca M, Zupi E, Bolis P. Müllerian hormone levels. Fertil Steril. 2010;94(1):343–349.
Randomized clinical trial of two laparoscopic treatments 13. Ding Y, Yuan Y, Ding J, Chen Y, Zhang X, Hua K.
of endometriomas: cystectomy versus drainage and Comprehensive assessment of the impact of laparoscopic
coagulation. Fertil Steril. 1998;70(6):1176–1180. ovarian cystectomy on ovarian reserve. J Minim Invasive
5. Hart RJ, Hickey M, Maouris P, Buckett W, Garry R. Excisional Gynecol. 2015;22(7):1252–1259.
surgery versus ablative surgery for ovarian endometriomata. 14. Mircea O, Puscasiu L, Resch B, et al. Fertility outcomes
Cochrane Database Syst Rev. 2005;(3):CD004992. after ablation using plasma energy versus cystectomy
6. Dunselman GA, Vermeulen N, Becker C, et al; European in infertile women with ovarian endometrioma: A
Society of Human Reproduction and Embryology. ESHRE multicentric comparative study. J Minim Invasive Gynecol.
guideline: management of women with endometriosis. Hum 2016;23(7):1138–1145.
Reprod. 2014;29(3):400–412. 15. Ozaki R, Kumakiri J, Tinelli A, Grimbizis GF, Kitade M,
7. Stochino-Loi E, Darwish B, Mircea O, et al. Does preoperative Takeda S. Evaluation of factors predicting diminished ovarian
antimüllerian hormone level influence postoperative reserve before and after laparoscopic cystectomy for ovarian
pregnancy rate in women undergoing surgery for endometriomas: a prospective cohort study. J Ovarian Res.
severe endometriosis? Fertil Steril. 2017;107(3):707–713.e3. 2016;9(1):37.
8. Motte I, Roman H, Clavier B, et al. In vitro fertilization outcomes 16. Demirol A, Guven S, Baykal C, Gurgan T. Effect of endometrioma
after ablation of endometriomas using plasma energy: A cystectomy on IVF outcome: A prospective randomized study.
retrospective case-control study. Gynecol Obstet Fertil. Reprod Biomed Online. 2006;12(5):639–643.
2016;44(10):541–547. 17. Kennedy S, Bergqvist A, Chapron C, et al; ESHRE Special
9. Roman H, Bubenheim M, Auber M, Marpeau L, Puscasiu L. Interest Group for Endometriosis and Endometrium
Antimullerian hormone level and endometrioma ablation Guideline Development Group. ESHRE guideline for the
using plasma energy. JSLS. 2014;18(3). diagnosis and treatment of endometriosis. Hum Reprod.
10. Saito N, Okuda K, Yuguchi H, Yamashita Y, Terai Y, Ohmichi 2005;20(10):2698–2704.
Coming soon...
Optimal management of stage 3 and 4 pelvic Update on cervical disease
organ prolapse Mark H. Einstein, MD, MS
Vincent R. Lucente, MD, MBA; Rebecca Rogers, MD;
Patrick Culligan, MD Deep infiltrating endometriosis:
Current evaluation and management
Reducing the rate of surgical site infection Rosanne M. Kho, MD; Mauricio S. Abrao, MD
following cesarean delivery
Robert L. Barbieri, MD Two good apps for management of
cervical cancer screening results
Update on genetic testing Katherine T. Chen, MD
Mary Norton, MD
What’s new in simulation training
Patient experience: It’s not about satisfaction for hysterectomy
James I. Merlino, MD; Amy A. Merlino, MD Alicia Scribner, MD, MPH; Christine Vaccaro, MD
Pearls for nitrous oxide use in the labor

and delivery unit
William Camann, MD

App REVIEW
ACOG app and applets:

Useful information at your fingertips
Katherine T. Chen, MD, MPH
T
he American College of Obstetricians apps (Practice Bulletins, Committee Opin-
and Gynecologists (ACOG) is a non- ions, an Estimated Due Date Calculator that
profit organization of women’s health was featured in a prior review,3 Indicated
care physicians advocating the highest stan- Delivery, and Immunize) (TABLE 2 , page 42),
dards of practice, continuing member edu- reference and information gathering apps
cation, and public awareness of women’s (Today’s Headlines), and member support
health care issues.1 The organization has apps (ACOG Contacts, Careers, Annual Meet-
long recognized the impact that social media ing, Districts, Council on Resident Education IN THIS
and mobile technology would have for itself in Obstetrics and Gynecology [CREOG], and ARTICLE
as well as its membership. ACOG published Website).4
a Social Media Guide in 2012, featuring a This review will focus on the main ACOG Review of ACOG
section on how to use apps in ObGyn prac- app, which is evaluated by a shortened ver- app and applets
tice and provided a list of apps for ObGyns sion of the APPLICATIONS scoring system,
page 42
and their patients.2 APPLI (app comprehensiveness, price, plat-
ACOG introduced its own app 4 years form, literature use, and important special
ago and has since updated the app several features).5 In addition, the clinical decision-
times, most recently on December 6, 2017. making applets will be highlighted in a sec-
The ACOG app has a useful search function, ond table. I commend ACOG for developing
a home button, and a place for users to email these useful tools to augment their mem-
feedback (TABLE 1 , page 42). The app most bers’ practices. Of note, for the Practice Bul-
importantly contains several applets (small letins and Indicated Delivery applets, users
applications designed to perform a specific will need to input their ACOG log-in access
function within the main application). These information.
applets encompass 3 types of apps for health
References
care providers: clinical decision-making 1. The American College of Obstetricians and Gynecologists
web site. https://www.acog.org/About-ACOG. Updated
2017. Accessed February 12, 2018.
Dr. Chen is Professor of Obstetrics, 2. ACOG today. The American College of Obstetricians and
Gynecology, and Reproductive Gynecologists https://www.acog.org/-/media/ACOG-Today
Science and Medical Education, /acogToday201211.pdf. Published November 2012. Accessed
Vice-Chair of Ob-Gyn Education for February 12, 2018.
the Mount Sinai Health System, Icahn 3. Chen KT. Three good apps for calculating the date of delivery.
School of Medicine, Mount Sinai, OBG Manag. 2017;29(1):45–46.
New York, New York. She is an OBG 4. Ventola CL. Mobile devices and apps for health care
ManageMent Contributing Editor. professionals: Uses and benefits. P T. 2014;39(5):356–364.
5. Chyjek K, Farag S, Chen KT. Rating pregnancy wheel
The author reports receiving royalties applications using the APPLICATIONS scoring system.
from UpToDate, Inc. Obstet Gynecol. 2015;125(6):1478–1483. CONTINUED ON PAGE 42
App Review 0318.indd 41 2/27/18 2:07 PM

App REVIEW
TABLE 1 The ACOG app

App Important special
App comprehensiveness Price Platform Literature used features
• Clinical decision- Free iTunes and Practice bulletins, See specific applet
making (clinical (a few Google Play committee descriptions in Table 2
decision support applets store opinions, and
systems, clinical require other primary
treatment guidelines, ACOG sources
ACOG medical calculators) log-in)
iTunes: • Communication and
https://itunes.apple.com/us consulting (e-mail)
/app/acog/id616323665?mt=8
• Reference and
Google Play: information gathering
https://play.google.com/store (medical news)
/apps/details?id=vspringboard
.acog.activity • Continuing medical
education
TABLE 2 The ACOG applets

ACOG log-in
Applet App type required Literature used Important special features
Clinical decision-making Yes Primary sources Updates on techniques and clinical
(clinical treatment guidelines) management issues
Practice
Bulletins
Clinical decision-making No Primary sources ACOG committee’s assessment of
(clinical treatment guidelines) emerging issues in ObGyn practice
Committee
Opinions
Clinical decision-making No ACOG Committee • Uses data from last menstrual period
(medical calculators) Opinion No. 700 and first accurate ultrasound to
determine estimated due date (EDD)
EDD
• Determines both estimated gestational
Calculator
age (EGA) for a target date and target
date for a gestational age
Clinical decision-making Yes None • Provides members with suggestions
(clinical decision support related to the timing of delivery based
systems) on selected conditions, the patient’s
Indicated EDD/EGA, and ACOG’s clinical
Communication and
Delivery guidance
consulting (e-mail)
• Allows members to e-mail or print
results for use in counseling patients
and or document in patient’s record
Clinical decision-making No National Interactive tool that provides
(clinical treatment guidelines) organizations immunization best practices /
recommendations / algorithms
Immunize
App Review 0318.indd 42 2/27/18 2:07 PM

SGS video series!
View this new video at
obgmanagement.com
SOCIETY OF
GYNECOLOGIC SURGEONS
Brought to you by the Society of Gynecologic Surgeons
Surgical anatomy and steps of the uterosacral ligament colpopexy

LAUREN N. SIFF, MD; KARL JALLAD, MD; LISA C. HICKMAN, MD; AND MARK D. WALTERS, MD
In this video, the authors illustrate the surgical anatomy of the uterosacral
ligament colpopexy. They present images from both cadaveric dissection
and live surgery to offer key steps of the procedure from several angles and
perspectives. The techniques highlighted include locating and protecting
the ureter and rectum, identifying the uterosacral ligament, placing and
anchoring the sutures, and elevating the vaginal cuff.
Copyright Society of Gynecologic Surgeons
Use this QR code* to view the video at mdedge.com/obgmanagement

*Free QR readers are available for smartphones at the iPhone App Store, Android Market, and BlackBerry App World.
ADs Ferring SGS 0318.indd 43 2/27/18 2:08 PM

PRODUCT Update
PRENATAL SCREENING PRESSURE-SENSING TECHNOLOGY
FOR SINGLE-GENE DISORDERS FOR EPIDURALS
Vistara®, a non-invasive pre- The CompuFlo® Epidural
natal test (NIPT) from Natera, from Milestone Scientific
Inc, screens for single-gene uses pressure-sensing tech-
disorders after 9 weeks’ gesta- nology to identify the epidural
tion. Complementing the Pan- space, and provides a com-
orama® NIPT, Vistara tests for puter-controlled drug delivery
major anatomic abnormalities system.
and chromosome imbalances Knowing the precise
that have a combined incidence rate of 1 in 600 (higher needle location during an epidural injection procedure
than Down syndrome). These mutations can cause provides a measure of safety not available to physicians
severe conditions affecting skeletal, cardiac, and neuro- who use conventional syringes. Milestone says that its
logic systems, such as Noonan syndrome, osteogenesis CompuFlo Epidural allows anesthesiologists to use
imperfecta, craniosynostosis syndromes, achondropla- both hands to advance and direct the needle, and to
sia, and Rett syndrome. Standard NIPT commonly can- confirm the epidural space with 99% accuracy on the
not detect these de novo (not inherited) mutations. first attempt.
Ultrasound exams may either completely miss the CompuFlo Epidural differentiates tissue types for
disorders or identify nonspecific findings later the medical professional via visual and audio feedback,
in pregnancy. leading to precise location guidance as the needle
Natera says that Vistara has a combined analyti- advances toward the intended area. It also allows for
cal sensitivity of >99% and a combined analytical spec- controlled needle exit pressure, precise flow rate and
ificity of >99% in validation studies. drug volumes, and patient treatment documentation.
FOR MORE INFORMATION, VISIT: FOR MORE INFORMATION, VISIT:
https://www.natera.com/vistara https://www.milestonescientific.com/products
/compuflo-epidural
ELECTROSTATIC SURGICAL
SMOKE REMOVAL OBGYN ULTRASOUND INNOVATIONS
The UltravisionTM Trocar Philips recently announced
device from Alesi Surgical enhancements to its EPIQ
Technologies uses a low- 7 and 5 and Affiniti 70 ultra-
energy electrostatic charge to sound systems. According
eliminate the surgical smoke to Philips, the eL18-4 trans-
generated by cutting instru- ducer provides high-detail
ments during laparoscopic resolution and image unifor-
surgery. Electrostatic precipi- mity with penetration for enhanced diagnostic quality
tation accelerates the natural process of sedimentation; in 1st- and 2nd-trimester obstetric exams. aBiometry
Ultravision creates negatively charged gas ions that AssistAI, with anatomical intelligence of fetal anatomy,
draw water vapor and particulate matter away from the streamlines fetal measurement by preplacing measure-
surgical site toward “positive” patient tissue. ment cursors on selected structures. The new TouchVue
Alesi says that bench studies comparing control-panel interface on TrueVue allows practitioners
Ultravision with a vacuum-system when using mono- to interact with finger gestures and to direct 3D-volume
polar, bipolar, and ultrasonic instruments show that its rotation and internal light-source position. The 2D Tilt
device is faster and more efficient than smoke evacu- feature offered on the 3D9-v3 transducer provides lat-
ation. When switched on before cutting, Ultravision eral scanning of anatomic structures that are off-axis
precipitates 99% of particles within 30 seconds. After without having to manually angle the transducer.
1 minute of continuous use, Ultravision precipitates These new features complement the existing
99.9% of particles, independent of particle size, from suite of Philips ObGyn ultrasound visualization tools:
7 nm to 10 µm. Smoke evacuation removes 30.2% of TrueVue, GlassVue, aRevealAI, and MaxVue.
particles after 1 minute, according to Alesi. FOR MORE INFORMATION, VISIT:
FOR MORE INFORMATION, VISIT: https://www.usa.philips.com/healthcare/resources
http://www.alesi-surgical.com /feature-detail/ultrasound-truevue-imaging
ProductUpdate 0318.indd 44 2/27/18 2:09 PM

What’s Your DIAGNOSIS?

Devaraju Kanmaniraja, MD, and Andrew M. Kaunitz, MD
CASE
A 37-year-old woman presents to the emergency department reporting left-sided pelvic pain for 2 weeks duration. She
has a negative urine pregnancy test. Pelvic ultrasonography of the left adnexa is performed with gray scale (A) and color
Doppler images (B).
A B
What is the diagnosis based on the

At the time of this writing, Dr. Kanmaniraja was
Assistant Professor and Chief, Division of Abdominal sonographic findings?
Imaging, Department of Radiology, University of Simple ovarian cyst
Florida College of Medicine–Jacksonville.
Hemorrhagic cyst
Endometrioma
Dermoid cyst
Dr. Kaunitz is University of Florida Term Professor and Cystic ovarian neoplasm
Associate Chairman, Department of Obstetrics and
Gynecology, University of Florida College of Medicine-
Turn the page to see if you are correct.
Jacksonville. He is Medical Director and Director of
Menopause and Gynecologic Ultrasound Services
at UF Women’s Health Specialists-Emerson. He also
serves on the OBG MANAGEMENT Board of Editors.
The authors report no financial relationships relevant to this quiz. This quiz
was published online January 23, 2017. CONTINUED ON PAGE 46
WYDiagnosis 0318.indd 45 2/27/18 2:09 PM

What’s Your DIAGNOSIS?
CORRECT
Hemorrhagic cyst
A hemorrhagic cyst is well-circumscribed and hypoechoic, with posterior acoustic enhancement and a lacy reticu-
lar pattern of internal echoes due to fibrin strands. The internal echoes also may be solid appearing with concave
margins due to a retractile hemorrhagic clot.1 The absence of internal vascular flow on color Doppler helps differen-
tiate it from the solid components seen in ovarian neoplasm.
A B
Hemorrhagic cyst. (A) Transvaginal pelvic ultrasound of the left ovary demonstrates a well-circumscribed hypoechoic cyst with
posterior acoustic enhancement and a lacy reticular pattern of internal echoes (long arrow). (B) Transvaginal pelvic ultrasound of
the right ovary shows a well-circumscribed hypoechoic cyst with a solid-appearing retractile hemorrhagic clot that has concave
margins (short arrow) and no vascular flow on color Doppler.
INCORRECT INCORRECT
Simple ovarian cyst Endometrioma
A simple ovarian cyst is a well-circumscribed, round An endometrioma is a well-circumscribed hypoechoic
or oval, anechoic, avascular cyst with posterior acous- cyst with homogeneous ground glass or low-level
tic enhancement and thin smooth walls.1 No septa- echoes and increased through transmission.1 It will
tions or solid components will be identified. appear avascular without solid components.
Simple ovarian cyst. Transvaginal pelvic ultrasound of the Endometrioma. Transvaginal pelvic ultrasound of the
left ovary demonstrates a well-circumscribed, oval, anechoic, right ovary demonstrates a well-circumscribed, avascular,
avascular cyst with posterior acoustic enhancement and thin, hypoechoic cyst with homogeneous ground glass or low-
smooth walls. level echoes and increased through transmission.

INCORRECT
Dermoid cyst
A dermoid cyst is a common benign ovarian tumor with varying appearances, the most common being a cystic
lesion with a focal echogenic nodule protruding into the cyst (Rokitansky nodule).2 The second most common
appearance is a focal or diffuse hyperechoic mass with areas of acoustic shadowing from the sebaceous material
and hair (tip-of-the-iceberg sign). A third appearance is a cystic lesion with multiple thin echogenic bands illustrat-
ing hair floating within the cyst. No internal vascular flow will be identified.
A B
Dermoid cysts. (A) Transvaginal pelvic ultrasound of the right adnexa demonstrates a cystic lesion with a focal echogenic nodule
protruding into the cyst (Rokitansky nodule) (long arrow) and multiple thin echogenic lines and dots (short arrow). (B) Transvaginal
pelvic ultrasound of the left adnexa shows a diffuse hyperechoic mass with areas of acoustic shadowing (arrowhead).
INCORRECT
Cystic ovarian neoplasm
A cystic ovarian neoplasm is a large complex mass with both cystic and solid components showing internal vascular flow.
These neoplasms usually demonstrate a thick irregular wall, multiple septations, and nodular papillary projections.3
A B
Borderline ovarian neoplasm. (A) Transvaginal pelvic ultrasound of the right adnexa demonstrates a large complex cystic and
solid mass with a thick irregular wall, multiple septations (arrow), and nodular papillary projections. (B) The mass shows internal
vascular flow on color Doppler images.
References
1. Levine D, Brown DL, Andreotti RF, et al. Management of asymptomatic ovarian imaging characteristics. Radiographics. 2001;21(2):475−490.
and other adnexal cysts imaged at US Society of Radiologists in Ultrasound 3. Wasnik AP, Menias CO, Platt JF, Lalchandani UR, Bedi DG, Elsayes KM.
consensus conference statement. Radiology. 2010;256:(3):943−954. Multimodality imaging of ovarian cystic lesions: review with an imaging based
2. Outwater EK, Siegelman ES, Hunt JL. Ovarian teratomas: tumor types and algorithmic approach. World J Radiol. 2013;5(3):113−125.

commonfund.nih.gov/promis/index. Reviewed May 8, 2017. A review of patient-reported outcome measures to assess

Accessed October 15, 2017. female infertility-related quality of life. Health Qual Life
15. International Consortium for Health Outcomes Measurement Outcomes. 2017;15(1):86.
(ICHOM). http://www.ichom.org/. Accessed October 15, 32. Sung VW, Joo K, Marques F, Myers DL. Patient-reported
2017. outcomes after combined surgery for pelvic floor disorders
16. University of Oxford, Patient Reported Outcomes in older compared to younger women. Am J Obstet Gynecol.
Measurement Group http://phi.uhce.ox.ac.uk/. Accessed 2009;201(5):534.e1–e5.
October 15, 2017. 33. Sung VW, Rogers RG, Barber MD, Clark MA. Conceptual
17. CONSORT. Patient-Reported Outcomes (CONSORT PRO). framework for patient-important treatment outcomes for
http://www.consort-statement.org/extensions/overview pelvic organ prolapse. Neurourol Urodynam. 2014;33(4):414–
/consort-pro. Accessed October 15, 2017. 419.
18. International Society for Pharmacoeconomics and Outcomes 34. Sung VW, Wohlrab KJ, Madsen A, Raker C. Patient-reported
Research. https://www.ispor.org/. Accessed October 15, 2017. goal attainment and comprehensive functioning outcomes
19. RAND Health. RAND medical outcomes study: measures of after surgery compared with pessary for pelvic organ
quality of life core survey from RAND Health. https://www prolapse. Am J Obstet Gynecol. 2016;215(5):659.e1–e7.
.rand.org/health/surveys_tools/mos.html. Accessed October 35. Croke J. Cervical ca PROs in clinical practice. https://
15, 2017. clinicaltrials.gov/ct2/show/NCT03048435. Accessed October
20. Basch EM, Deal AM, Dueck A, et al. Overall survival results 16, 2017.
of a randomized trial assessing patient-reported outcomes 36. Catt S, Starkings R, Shilling V, Fallowfield L. Patient-reported
for symptom monitoring during routine cancer treatment outcome measures of the impact of cancer on patients’
[abstract LBA2]. J Clin Oncol. 2017;35(18)(suppl). everyday lives: a systematic review. J Cancer Surviv.
21. Centers for Medicare and Medicaid Services. Better care. 2017;11(2):211–232.
Smarter spending. Healthier people: paying providers 37. Jensen RE, Potosky AL, Moinpour CM, et al. United States
for value, not volume. https://www.cms.gov/Newsroom population estimates of patient-reported outcomes
/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets measurement information system symptom and functional
-items/2015-01-26-3.html. Accessed October 15, 2017. status reference values for individuals with cancer. J Clin
22. Basch E, Deal AM, Kris MG, et al. Symptom monitoring with Oncol. 2017;35(17):1913–1920.
patient-reported outcomes during routine cancer treatment: 38. Friedlander M, Mercieca-Bebber RL, King MT. Patient-
a randomized controlled trial. J Clin Oncol. 2016;34(6): reported outcomes (PRO) in ovarian cancer clinical
557–565. trials—lost opportunities and lessons learned. Ann Oncol.
23. Chenok K, Teleki S, SooHoo NF, Huddleston J, Bozic KJ. 2016;27(suppl 1):i66–i71.
Collecting patient-reported outcomes: lessons from the 39. Joly F, Hilpert F, Okamoto A, Stuart G, Ochaia K, Friedlander
California Joint Replacement Registry. EGEMS (Wash DC). M; 5th Ovarian Cancer Consensus Conference. Fifth Ovarian
2015;3(1):1196. Cancer Consensus Conference of the Gynecologic Cancer
24. Frosch DL. Patient-reported outcomes as a measure of InterGroup: recommendations on incorporating patient-
healthcare quality. J Gen Intern Med. 2015;30(10):1383–1384. reported outcomes in clinical trials in epithelial ovarian
25. Gibbons E, Mackintosh A, Fitzpatrick R; Patient-Reported cancer. Eur J Cancer. 2017;78:133–138.
Outcome Measurement Group, Oxford. A structured 40. Martin A. Patient-reported outcomes in studies published in
review of patient-reported outcome measures for people 2014: which disease areas have been the main focus of clinical
undergoing elective procedures for benign gynaecological research? Value Health. 2015;18(7):A742.
conditions of the uterus, 2010. http://phi.uhce.ox.ac.uk/pdf 41. International Consortium for Health Outcomes Management
/ElectiveProcedures/PROMs_Oxford_Gynaecological%20 (ICHOM). Pregnancy and childbirth. http://www.ichom.org
procedures_012011.pdf. Accessed October 23, 2017. /medical-conditions/pregnancy-and-childbirth/. Accessed
26. Matteson KA, Boardman LA, Munro MG, Clark MA. October 10, 2017.
Abnormal uterine bleeding: a review of patient-based 42. El Haj Ibrahim S, McCulloch J, Korst LM, Fridman M, Fink A,
outcome measures. Fertil Steril. 2009;92(1):205–216. Gregory KD. Communication with staff during hospitalization
27. Matteson KA, Scott DM, Raker CA, Clark MA. The menstrual for childbirth: the patient’s perspective [1R]. Obstet Gynecol.
bleeding questionnaire: development and validation of a 2016;127.
comprehensive patient-reported outcome instrument for 43. National Partnership for Women and Families. Childbirth
heavy menstrual bleeding. BJOG. 2015;122(5):681–689. Connection. Listening to mothers III: report of the third
28. Coyne KS, Margolis MK, Bradley LD, Guido R, Maxwell national US survey of women’s childbearing experience.
GL, Spies JB. Further validation of the uterine fibroid http://transform.childbirthconnection.org/reports
symptom and quality-of-life questionnaire. Value Health. /listeningtomothers/. Accessed October 23, 2017.
2012;15(1):135–142. 44. Gartner FR, Freeman LM, Rijnders ME, et al. A comprehensive
29. Martin ML, Halling K, Eek D, Krohe M, Paty J. Understanding representation of the birth-experience: identification and
polycystic ovary syndrome from the patient perspective: a prioritization of birth-specific domains based on a mixed-
concept elicitation patient interview study. Health Quality method design. BMC Pregnancy Childbirth. 2014;14:147.
Life Outcomes. 2017;15(1):162. 45. National Partnership for Women and Families. The priority
30. Malik-Aslam A, Reaney MD, Speight J. The suitability of of developing and implementing CAHPS maternity care
polycystic ovary syndrome-specific questionnaires for facility, clinician and health plan surveys. 2015. http://www
measuring the impact of PCOS on quality of life in clinical .nationalpartnership.org/research-library/maternal-health
trials. Value Health. 2010;13(4):440–446. /cahps-maternity-care-fact-sheet.pdf. Accessed October 23,
31. Kitchen H, Aldhouse N, Trigg A, Palencia R, Mitchell S. 2017.
Watch for part 4 of the value-based medicine series:

Training: How can we educate residents and students
on how much things cost?
Mark Woodland, MD, MPH
Gregory 0318.indd 48 2/27/18 2:03 PM

Have you visited
this week?
CPT and Medicare coding changes for 2018 Practice essentials:

Melanie Witt, RN, MA Everyday contraception considerations
Ronald T. Burkman, MD
Endometriosis: Expert perspectives on medical
and surgical management The felt pelvic anatomy model:
Arnold P. Advincula, MD; Douglas N. Brown, MD; A teaching tool for students and residents
and Hye-Chun Hur, MD, MPH Polina Advolodkina, MD; Katherine Desouza, MD;
Jessica Arluck, MD; and E. Britton Chahine, MD
Enhanced recovery after surgery Brought to you by the Society of Gynecologic Surgeons
for the chronic pain patient
Janelle Moulder, MD, MSCR, Are these the right metrics to
and K. Paige Johnson, MD measure episiotomy rates?
Myron R. Kanofsky, MD
Tackling opioids and maternal health
in the US Congress FDA issues safety measures for all
Lucia DiVenere, MA, with Phil Roe, MD (R-Tenn.) gadolinium-based contrast agents for MRI
Surgical anatomy and steps of the uterosacral Should immediate cord clamping be performed
ligament colpopexy for preterm infants?
Lauren N. Siff, MD; Karl Jallad, MD; John T. Repke, MD
Lisa C. Hickman, MD; and Mark D. Walters, MD
Brought to you by the Society of Gynecologic Surgeons Medical Verdicts: Endometriosis surgery
on a young woman: $483,351 award
Can women who have immediate postpartum
LNG-IUD insertion breastfeed? How to avoid and manage complications
John T. Repke, MD when placing ports and docking
John P. Lenihan Jr, MD
Plus, visit us online for daily news!
Of course, current and past articles are still there for you—in full text and as
convenient, downloadable PDF files. And you’ll find an easy way to contact us.
OBGM_0318_WebAD.indd 49 2/27/18 2:11 PM

EXCLUSIVE MULTIMEDIA COLLECTION
PRACTICE ESSENTIALS
Everyday contraception
considerations
Dr. Ronald T. Burkman provides insights on using the
CDC’s tools to solve complex contraception cases,
obesity and contraceptive efficacy, the risk of venous
thromboembolism with hormonal contraception,
considerations for women with headache and
migraine, choosing emergency contraception for your
patient, and more. Use this e-collection of articles
and webcasts as a resource for your practice.
Find this exclusive collection only at

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COMMENT & CONTROVERSY

days I would order oxycodone plus acet- control for women, such as after a anti-inflammatory drugs (NSAIDs) and
aminophen for 1 to 2 days postoperative cesarean delivery. I would like to see oral acetaminophen. Drs. Toler and Hale
cesarean delivery, and only 1 day after any male have major surgery through are concerned that postpartum pain
normal spontaneous delivery if the a large muscle like the uterus and not control might be suboptimal if opioids
patient had a large perineal repair or mul- need significant pain control options! are underprescribed. However, in many
tiparous involution pain. Otherwise, it Anne V. Hale, MD developed countries obstetricians do
was ibuprofen 800 mg, then 400 to 600 mg El Paso, Texas not use opioid pain medicine for post-
on discharge home. partum pain management, relying on
Gabrielle Long, CNM Dr. Barbieri responds NSAIDs and acetaminophen. Given the
Mohegan Lake, New York I agree with Ms. Long that most post- success of this approach, I think we can
partum patients, including many who significantly reduce the use of opioids by
Respect women’s postsurgical have had a cesarean delivery, can postpartum women in the United States
pain management needs achieve adequate pain control with the by optimizing our use of nonopioid
There is a real disrespect for pain use of parenteral and oral nonsteroidal medications.
52 OBG Management | March 2018 | Vol. 30 No. 3 me djobn etw or k.com
OBG_0318_Classifieds.indd 52 2/27/18 2:12 PM

OBG ManageMent salutes the members of the Virtual Board of Editors
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Chillicothe, Missouri Brooklyn, New York Meridian, Mississippi
VBE_0318.indd 3 2/27/18 2:12 PM

NOW AVAILABLE
DEMONSTRATED TO SIGNIFICANTLY DECREASE MODERATE
TO SEVERE DYSPAREUNIA DUE TO MENOPAUSE1
Not actual size.

NON-ESTROGEN BASED, CONVERTS TO
ESTROGENS AND ANDROGENS*
Prasterone is a precursor that is locally converted
to estrogens and androgens with minimal systemic
exposure.1,2 *The mechanism of action of INTRAROSA NO FDA BOXED WARNING2
is not fully established1 No restrictions on duration of use2,3
ONCE-DAILY TREATMENT
Individually wrapped vaginal inserts with
disposable applicators1 To order samples and learn more about INTRAROSA,
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Indication
INTRAROSA is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due
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INTRAROSA is contraindicated in women with undiagnosed abnormal genital bleeding. Estrogen is a metabolite of prasterone. Use of
exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. INTRAROSA has not been studied in
women with a history of breast cancer.
In four 12-week randomized, placebo-controlled clinical trials, the most common adverse reaction with an incidence ≥2 percent was
vaginal discharge. In one 52-week open-label clinical trial, the most common adverse reactions with an incidence ≥2 percent were vaginal
discharge and abnormal Pap smear.
Brief Summary: Consult full Prescribing Information for complete INTRAROSA treatment group with an incidence of ≥2 percent and
product information. greater than reported in the placebo treatment group. There were
38 cases in 665 participating postmenopausal women (5.71 percent)
CONTRAINDICATIONS
in the INTRAROSA treatment group compared to 17 cases in 464
Undiagnosed abnormal genital bleeding: Any postmenopausal
participating postmenopausal women (3.66 percent) in the placebo
woman with undiagnosed, persistent or recurring genital bleeding
treatment group.
should be evaluated to determine the cause of the bleeding before
consideration of treatment with INTRAROSA. In a 52-week non-comparative clinical trial [92% - White Caucasian
non-Hispanic women, 6% - Black or African American women, and
WARNINGS AND PRECAUTIONS Current or Past History of 2% - “Other” women, average age 57.9 years of age (range 43 to
Breast Cancer 75 years of age)], vaginal discharge and abnormal Pap smear at
Estrogen is a metabolite of prasterone. Use of exogenous estrogen 52 weeks were the most frequently reported treatment-emergent
is contraindicated in women with a known or suspected history of adverse reactions in women receiving INTRAROSA with an
breast cancer. INTRAROSA has not been studied in women with a incidence of ≥2 percent. There were 74 cases of vaginal discharge
history of breast cancer. (14.2 percent) and 11 cases of abnormal Pap smear (2.1 percent) in
ADVERSE REACTIONS Clinical Trials Experience 521 participating postmenopausal women. The eleven (11) cases of
Because clinical trials are conducted under widely varying abnormal Pap smear at 52 weeks include one (1) case of low-grade
conditions, adverse reaction rates observed in the clinical trials of squamous intraepithelial lesion (LSIL), and ten (10) cases of atypical
a drug cannot be directly compared to rates in the clinical trials of squamous cells of undetermined significance (ASCUS).
another drug and may not reflect the rates observed in practice.
References: 1. Intrarosa [package insert]. Waltham, MA: AMAG Pharmaceuticals, Inc.;
In four (4) placebo-controlled, 12-week clinical trials [91% - White 2017. 2. Archer DF, Labrie F, Bouchard C, et al; VVA Prasterone Group. Menopause.
Caucasian non-Hispanic women, 7% - Black or African American 2015;22(9):950-963. 3. Labrie F, Archer DF, Koltun W, et al; VVA Prasterone Research
women, and 2% - “Other” women, average age 58.8 years of Group. Menopause. 2016;23(3):243-256.
age (range 40 to 80 years of age)], vaginal discharge is the most

frequently reported treatment-emergent adverse reaction in the
INTRAROSA is a trademark of Endoceutics, Inc.

Distributed by AMAG Pharmaceuticals, Inc., Waltham, MA 02451
© 2017 AMAG Pharmaceuticals, Inc. All rights reserved. PP-INR-US-00153 09/17

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