AUFMED

Dr. Agnes Gaddi | August 10, 2015 | OBSTETRICS

TERATOLOGY, MEDICATIONS AFFECTING THE FETUS, and
IMMUNIZATION DURING PREGNANCY

OUTLINE
1. Teratogenicity
- Criteria for Proof of Human Teratogenicity
2. Maternal Consumption of Drugs
- Placental Transfer of Drugs
- Physicochemical Factors Affecting Placental
Transfer of Drugs
- Placental and Fetal Circulation
- Fetal Exposure to a Drug
- Drug Effects to a Fetus
- Staging of Fetal Development
3. USDA Five Risk Categories
4. Genetic and Physiological Susceptibility to
Teratogens
5. Effects of Drug on Fetus
6. Immunization During Pregnancy
TERATOGENICITY

Criteria for Proof of Human Teratogenicity

1. Careful delineation of clinical cases
The defect must be completely characterized and
therefore it should be repetitive and almost the
same in many cases. Many genetic and
environmental factors produce the same defect
(phenocopies).
To
identify
teratogenicity
whenever a drug has been approved for use, there
should be follow-up studies and case control
surveillance after drug has been released and
used by the population.
Step 1: Drug is studied first in the laboratory.
Step 2: Drug is then tested in animals.
Step 3: Progresses to case trials where they are
used in selected and willing individuals.
Step 4: Surveillance after use of the drug.

Drugs and the Fetus

Teratology is the study of birth defects.

Teratogen is defined as any agent chemicals,
viruses, environmental agents, physical factors,
and drugs that act during embryonic or fetal
development to produce a permanent alteration in
form or function
Although several drugs are possible teratogens in
human beings, at present only a few have been
positively identified.
The best-known teratogen is thalidomide. The
discovery that thalidomide caused congenital
malformations was possible because the drug was
widely used in the 1950s and 1960s and induced
dramatic and rare congenital defects and a high
probability (an estimated 25-30%)
It has been estimated that to establish that a given
drug changes the naturally occurring frequency of
a congenital deformity by 1% would require a
sequential trial of 35,000 patients.
In doses that it can cause analgesia to mother, it
was proven to have major teratogenic effects such
as phocomelia.
Many drugs are released for any reason without
testing it for teratogenic effects as it is unethical. If
problems develop after drug is released, a study
will then be conducted. It is unethical to conduct a
prospective study regarding this, as the babys
consent cannot be elicited
Follow-up and case control surveillance are the
two studies that can be done.

2. Rare environmental exposure associated with

rare defect, with at least three reported cases
easiest if defect is severe.
Cleft palate is widely known to be multifactorial.
There is a long list of anomalies but many still are
not in the literature. At least three instances of the
effect is the criteria needed for investigation.
3. Proof that the agent acts on the embryo of the
fetus directly or indirectly.
The agent must cross the placenta. With few
exceptions, all drugs cross the placenta, but it
must be shown that the drug cross in:
a. Sufficient amount to directly influence fetal
development or
b. Alter maternal or placental metabolism to
exert an indirect fetal effect.
There are chemical properties of the drug that
allows them to cross the placental membranes.
Often times, what happens is simple passive
diffusion. There is large concentration of drug in
the maternal circulation and little or none is in the
fetal circulation. Thus, drug diffuses passively to
the fetal circulation.
4. Consistent findings of two (2) or more
epidemiological studies of high quality:
The initial evaluation of teratogen exposure is
usually retrospective and therefore, it can be
tampered by bias, inadequate reporting and

PI Arellano | Gagui | Galvan | Pamintuan | Timbang

PROPERTY OF AUFSOM BATCH 2017
v3.1 s2015-2016

Page 1 of 9

incomplete assessment of the exposed

population. Investigation is often confounded by a
variety of factors.
There should be:
a. Control of confounding factors
b. Sufficient numbers
c. Exclusion of positive and negative bias factors
d. Prospective studies, if possible
e. Relative risk of three or more (necessary to
support hypothesis)
Many good drugs in the market have been put out
because of litigation cases against manufacturers.
Even if proven wrong, the negative publicity gives
manufacturers no choice but retract drug.

6. The association must be biologically plausible.

It is always possible that an exposure and defect
are not causally related. A 1:1 anomaly wherein
one exposure and one defect results do not
usually happen.
7. Teratogenicity in experimental animals has
been proven, especially primates.
Human teratogenicity is more likely, if the agent
produces adverse effects in many different
species especially subhuman primates.
If the teratogen causes defects in many species,
then it might be also teratogenic in humans,
especially so if it becomes positive in some human
primates (e.g. monkeys, gorillas, etc.)

5. Proven exposure to agent at critical time/s in

prenatal development.
Pre-Implantation Period
- First 2 weeks from fertilization to implantation is
the all or none period
o Implantation 8 to 9 weeks
- Division from one-cell to the 6th cell to the 8th cell
morula
- If insult happens to this particular stage, there will
be a decrease in the number of cells. If there is a
decrease in the number of cells in the 6 cell stage,
there will be death.

MATERNAL CONSUMPTION OF DRUGS

1. Drugs are administered for symptomatic relief
of benign problems in the mother (like pain,
vomiting, dizziness especially in the 1st trimester)
with little or no consideration to the unintended
recipient.
o

Embryonic Period
- 2nd to 8th week
- Organogenesis happens
- The most crucial period for structural abnormalities
- Insults that may happen in this particular stage
may allow life but there can be major congenital
anomalies that may also not allow line
extrauterine.
Fetal Period
- After 8 weeks (fetopathy, in contrast with 2 to 8
weeks, embryopathy)
- Certain organs remain vulnerable
An important aspect of teratology is that teratogenic
medications administered after vulnerable period
usually will not cause structural malformations.
Timing of Exposure to Drug:
2nd to 6th week CNS, heart, extremities, eyes,
palate, etc.
From 6th week genitalia
First 2 weeks cleavage occurs; if an insult
occurs, there would be death of the zygote;
failure of implantation
2nd to 8th week if catastrophic, structural
defects occur; sometimes incompatible with
life; occasionally, it may be compatible with life
but there would be growth restriction and
transplacental carcinogenesis may occur

PI Arellano | Gagui | Galvan | Pamintuan | Timbang

PROPERTY OF AUFSOM BATCH 2017
v3.1 s2015-2016

3rd to 9th month CNS development is affected

and also abnormalities of the heart (minor and
compatible with life)

o
o

Many are not educated, they do not know that

whatever they take in will also be passed to the
fetus.
Average number of prescribed drugs taken during
pregnancy = 4.
If self-prescribed are included, this number
increases to 10.

2. Many pregnant women have conditions for

which specific drug therapy is indicated
o
o
o
o

Many patients will have prescriptions to

medications.
Most drugs (with few notable exceptions)
prescribed for common medical or surgical
diseases can be used with relative safety.
E.G. antihypertensive drugs, diabetics
Moreover, if untreated disease may pose more risk
to the mother and fetus, it is more beneficial to take
the drug. DM, if untreated may cause multiple
effects to the mother and fetus.

Placental Transfer of Drugs

Placental transfer depends on:
o Maternal metabolism
o Specific characteristics of the drug
o Molecular size/weight
o Storage
o Protein-binding
o Electrical charge or degree of ionization

Page 2 of 9

Lipid solubility
Placental
maturation
and
metabolism of drugs
Placental and fetal circulation

Physicochemical Properties Affecting Placental

Transfer of Drugs
o Molecular Weight (Daltons)
250 500 daltons = easily crosses
500 1000 daltons = more difficult
1000 dalton = + very poorly
Exceptions to the size rule are maternal antibody
globulins and some polypeptides (peptide hormones
AVP, ACTH, etc.)
Heparin is large, so it does not cross the placenta. It is the
treatment of choice for patients who need coagulation
during pregnancy.
Warfarin crosses the placenta, and thus can cause
adverse effects to the fetus.
o

Lipid Solubility
Lipophilic drugs tend to diffuse readily
Highly ionized drugs tend to cross slowly.
If the maternal-fetal concentration gradient is
high enough, polar compounds will cross the
placenta
There is, most of the time, passive diffusion
but some substances can transfer by active or
facilitated transfer.
Placental Maturation
As the placenta develops, its physiology
changes including transport of drugs and
enzymes that can continuously degrade or
metabolize drugs.there are new enzymes as
the placenta grows and develops .
Sometimes if the primary compound of the
drug is not teratogenic, it is the by-products of
the drugs degradation that may cause
teratogenic effects.

The primary mode of drug transfer is passive

non-ionic diffusion
There are many amino acid, peptide, ion,
sugar nucleotide transporters in the brushborder membrane of the syncytiotrophoblast
cells.

Metabolism of Drugs
The metabolic activity of the placenta may
lead to creation of toxic metabolites
The metabolites of some drugs are more
active than the parent compounds and may
affect the fetus more strongly than the parent
compound.

PI Arellano | Gagui | Galvan | Pamintuan | Timbang

PROPERTY OF AUFSOM BATCH 2017
v3.1 s2015-2016

Placental and Fetal Circulation

o Drugs that cross the placenta enter the fetal
circulation via the umbilical vein 40-60% of
umbilical blood flow enters the fetal liver and the
remainder bypasses the liver and goes to the
general fetal circulation.
o During pregnancy, we know that the placenta
grows by the number of its cotyledons, by the size
and by the size of its cotyledons and by the
number of blood vessels crossing.
o The thinnest surface area increases from 3-4 to
12.6 mm during pregnancy.
Fetal Exposure to a Drug
- The extent of fetal exposure to a drug
administered to the mother will depend on:
o The above physicochemical properties
that determine placental transfer
o Dose of the drug
o Duration of treatment
o Rate of drug maternal drug elimination
and it will mimic the exposure of the mother to the fetus.
High dose in the mother slow elimination what the
mother gets, the fetus get
A drug that is proton bound is diffused more slowly.
However, accumulation of drug may accumulate if multiple
doses are given.
Higher concentration and multiple doses causes higher
concentration in fetal compartment.
Effect of Drugs on the Fetus
Currently, the fetus is only a passive recipient of drugs, and
consequently any drug effects are undesirable unless
proven otherwise.
Antipyretic on the mother also relieves fever of the fetus
IgG given to the mother may pass in the placenta and
lodge to the baby and it is beneficial as it joins the pool of
antibodies on the fetus.
Effects on the fetus may vary from:
o Reversible effects like transient behavioral
changes, transient changes in clotting time or fetal
breathing movements.
o Irreversible consequence like fetal death, IUGR,
structural malformations and mental retardation
Staging of Fetal Development
Timing of Drug Exposure
-

Period of Zygote: first week after conception

when cleavage occurs. Most common effect is
miscarriage. May lead to decreased cell number in
the blastocyst.

Page 3 of 9

Embryonic Period: second to eight weeks when

organogenesis occurs. Catastrophic structural
defects (thalidomide), fetal wastage, fetal growth
restriction and transplacental carcinogenesis
(DES) may result.
Fetal Period: third to ninth month. CNS
development, behavioral teratogenic effect.

Fetal brain is susceptible to insults even at birth, which is

only 80% developed at birth and continues to develop until
adult life.
USDA- FIVE RISK CATEGORIES
Category A
- Controlled studies in women fail to demonstrate a
risk to the fetus in the first trimester
Category B
- Either animal studies have not shown fetal risk but
no controlled studies in pregnant women have
been reported,
or animal studies have shown an adverse effect
that was not shown in woman in the first trimester,
e.g. Ampicillin.
Category C
- Either animal studies have revealed an adverse
effect on the fetus but no controlled studies in
women have been reported, or studies in animals
or women are not available,
- E.g., AZT.
Category D
- Positive evidence of human fetal risk exists, but
the benefits from use in pregnant women may be
acceptable despite the risk (e.g., drug required for
a life-threatening illness)
- E.g., Dilantin
Category X
- Studies in animals or humans have demonstrated
fetal abnormalities, or evidence exists of fetal risk
based upon human experience, or both, and the
risk clearly outweigh any possible benefit. The
drug is contraindicated in women who are at risk
of becoming pregnant.
- E.g., Accutane
Additional information found on Table 12-3, Appendix A.
GENETIC AND PHYSIOLOGICAL SUSCEPTIBILITY TO
TERATOGENS
A. Fetal Genome
Genetic composition has been linked to susceptibility to
teratogenic effects of specific medications. Ex. Fetuses
exposed to hydantoin are more likely to develop anomies
if homozygous for a gene mutation that results in
abnomally low levels of epoxide hydrolase.

PI Arellano | Gagui | Galvan | Pamintuan | Timbang

PROPERTY OF AUFSOM BATCH 2017
v3.1 s2015-2016

B. Homeobox gene teratogenicity

Homeobox genes are regulatory and encode proteins that
act as transcription factors. Any drug that obstructs
function in the production of these proteins can cause
structural abnormalities.
Ex.
1. Retinoic acid abnormalities in the hindbrain and
limb buds
2. Valproic acid prevent normal closure of the
posterior neuropore (neural tube defects)
C. Disruption of Folic Acid Metabolism
Fetuses who were exposed during embryogenesis to folic
acid antagonists (anticonvulsants), had a 3x risk of oral
clefts, cardiac defects and urinary tract abnormalities
D. Paternal Exposures
Proposed mechanisms include induction of a gene
mutation or chromosomal abnormality in sperm. Because
of the 64 days in which male germ cells mature into
functional spermatogonia, drug exposure during the 2
months before conception could cause gene mutations.
(ex. Ethyl alcohol, cyclophosphamide, lead, opiates).
That is why doctors planning to conceive are not advised
to go the operating room when general anesthesia is being
inducted.
Another possibility is that during intercourse, the
developing embryo is exposed to a teratogenic agent in
seminal fluid.

EFFECTS OF DRUG ON FETUS

Teratogens likely act by disturbing specific physiological
processes which leads to cell death, altered tissue growth
or abnormal cellular differentiation
- May vary from reversible effects like transient
behavioral changes, transient changes in clotting
time, transient changes in the fetal breathing
movements. Irreversible effects also occur like
fetal death, IUGR, structural malformations, and
mental retardation.
- The effects of drugs on the fetus are highly
dependent on individual drugs.
- Within same group of drugs, each individual drug
can cause the same type of malformation.
E.g. anticonvulsants
Three or four drugs that are considered
anticonvulsants may produce the same
effect
- In another class, each individual drug differ greatly
in their teratogenic potential
E.g., sedatives-hypnotics

Page 4 of 9

I. Angiotensin Converting Enzymes (ACE inhibitors)

- An anti-hypertensive agent which has good effect
among hypertensive patients because of improved
renal function and cardiac-sparing effects.
- Disrupt the fetal renin-angiotensin systems
- Out of 209 fetus exposed to ACE inhibitors, 8%
had major congenital anomalies (compared to
2.9% in the general population)
- Causes fetal hypotension, renal hypoperfusion
with subsequent ischemia and anuria
- Reduced perfusion causes fetal-growth restriction
and calvarium maldevelopment.
- Fetal anuria and problems with fetal swallowing
(fetus does not swallow) causes oligohydramnios
resulting to pulmonary hypoplasia and limb
contractures.
II. Antifungals
- Fluconazole
is
associated
with
skull
abnormalities, cleft palate, humeral-radial fusion
- Local brands include difloccan
- Pregnant patients are prone to fungal infections
such as candidiasis. Pregnant patients are usually
given local acting vaginal cream as the oral
antifungals are contraindicated.
- Fluconazole is the only known antifungal agent
with teratogenic effects.
- 400-800 mg/day in first trimester for severe fungal
infections
- 150 mg single dose for patients with vulvovaginal
candidiasis (as suppositories)
III. NSAIDS
- Most are safe in pregnant women except for
indomethacin
- Examples of NSAIDS: aspirin and ibuprofen
- Function is to inhibit prostaglandin production
- Low dose aspirin (80 mg) used among patients
with history of MI and also given among pregnant
patients with high risk for developing preeclampsia (though controversial)
a. Indomethacin
- In the 3rd trimester, cause constriction of the fetal
ductus pulmonary hypertension
- Intraventricula hemorrhage, bronchopulmonary
dysplasia and necrotizing enterocolitis
b. Leflunomide
- Pyrimidine synthesis inhibitor used to treat
rheumatoid arthritis.
- Embryo death, hydrocephalus, eye anomalies,
skull abnormalities (in multiple animal species)
IV. Antimicrobials
- Aminoglycosides causes auditory/ocular nerve
damage
- Sulfonamides pose conflicting reports on
teratogenicity (It causes decrease in lecithin-

PI Arellano | Gagui | Galvan | Pamintuan | Timbang

PROPERTY OF AUFSOM BATCH 2017
v3.1 s2015-2016

sphingomyelin ratio as well as increases risk for

convulsion)
Tetracycline causes staining of dentition

V. Antimalarials
- Quinidine causes deafness
- Mefloquine causes stillbirths
- Chloroquine (Fansidar) safe for pregnancy
VI. Antivirals
- Ribavirin inhalation given intranasally is highly
teratogenic in multiple species (skull, palate, eye,
limb and GI abnormalities)
VII. Hormonals
a. Androgens (at 7-12 weeks)
- Full masculinization does not progress after bith
- Reversed after birth
b.
-

Norethindrone
Progestin found in the pills
It causes masculinization in 1% of exposure
Other progestins (e.g. medroxyprogesterone
acetate) given to women with AUB are not found
to be teratogenic

c. DES
- Found to have structural abnormalities in the
cervix, vulva and vagina, adenosis and some
cancers especially clear cell CA in female fetuses
- Epididymal cysts, microphallus, cryptorchidism,
testicular hypoplasia
- Majorities are adenosis in the cervix, vulva and
vagina. Many of these adenosis may become the
jumping point for malignancy
- 1940 1971 about 2 million women in U.S. were
given DES (synthetic estrogen) and it was found
to have caused genital tract abnormalities in 30 to
35%.
VIII. Antineoplastic agents
- Cyclophosphamide may cause missing and
hypoplastic digits. It is usually given among
patients with GI and blood cancers.
Methotrexate and Aminopterin may cause MAS IUGR,
failure of calvarial ossification, craniosynostosis,
hypoplastic supraorbital ridges, small posteriorly rotated
ears, micrognathia, and severe limb abnormalities.
IX. Immunosuppressives
o Corticosteroids - Cleft palate
- High doses over a long period of time but short
doses of corticosteroids, like what we give for
preterm babies in whom we want to increase
surfactant, they are given over a 48 hour period. 46 doses of Betamethasone or hydrocortisone.
These are found safe and are given in the third
trimester

Page 5 of 9

o
o

Mycophenolate Mofetil - Ear and Auditory Canal

Anomalies
Radioactive Iodine (crosses the placenta) - Fetal
Thyroid Ablation (irreversible fetal hypothyroidism)

X. Psychiatric Medications
o Lithium - Ebstein anomaly, hypothyroidism,
diabetes
insipidus,
cardiomegaly,
ECG
abnormalities, cyanosis, hypotonia
o SSRIs
o Paroxetine - Cardiovascular malformations
- 2-3x
increased
risk
for
omphalocoele,
craniosynostosis and anencephaly, neonatal
behavioral syndrome (jitteriness, irritability or
agitation, increased muscle tone, feeding or
digestive disturbances)
- Many of which are irreversible
XI. Retinoids (Vit A derivative)
o Isotretinoin, Acitretin, Bexarotene given orally Cranial- neural crest defects (retinoic acid
embryopathy)
o Retinol - cranial-neural crest defects
- It is a preformed vitamin A. its a natural vitamin A
- Beta carotene non teratogenic
- It is naturally occurring in fruits and vegetables.
They are safe.
o Topical Retinoids
- No evidence of teratogenicity
- Popular among women, it counteracts the effects
of the sun at the same time, it is anti acne. If
applied in large quantities over a huge surface
area, it is almost the same as taking it orally. There
may be an accumulation or systemic absorption.
Discourage patient from using topical retinoids.
XII. Thalidomide
- There is a relationship between timing of exposure
to the type of structural abnormality.
- Exposure days
27-30 = upper phocomelia
30-33 = lower limb phocomelia
42-43 = gall bladder aplasia
40-47 = duodenal atresia
- Exposure days are days after menstruation.
Meaning, if you have fertilization at day 14, your
phocomelia can happen at 2 weeks of age from
fertilization.
XIII. Other Drugs:
Warfarin (6th-9th weeks)
o Vit. K antagonist
o Low molecular weight, so it readily crosses the
placenta
o Stippling of the vertebrae and femoral epiphysis,
nasal hypoplasia, choanal atresia
o Beyond the first trimester= hemorrhage into the
fetal structures abnormal growth in the brain
especially in the optic nerve (agenesis of the
corpus callosum, micropthalmia, optic atrophy

PI Arellano | Gagui | Galvan | Pamintuan | Timbang

PROPERTY OF AUFSOM BATCH 2017
v3.1 s2015-2016

Illicit Drugs
Cocaine - Vascular disruption in the fetus skull defects,
ileal atresia, porencephaly, cardiac anomalies, visceral
infarcts
o Drug with multi-system effect
Opiates
Heroin - IUGR, perinatal complications, death,
developmental delay, behavioral disturbances
o Withdrawal symptoms: irritability, sneezing, fever,
diarrhea, seizures (later trimester)
Methadone - withdrawal symptoms
Examples of Known and Suspected Teratogens: NonTherapeutic Agents
1. Alcohol
- Chronic intake is associated with the fetal alcohol
syndrome (US prevalence = 0.6 to 3/1000 births)
- Most frequent documented cause of mental
retardation in the western world
- Birth defects and neuro-behavioral disorders
related to it is 9/1000 live births
- Alcohol effect on the fetus is dose-related
Average of 8 ounces intake per day
23% frontal cortex below the 10th
percentile
16% premature births
28% small for dates
32% congenital malformations
Binge drinking linked to increased risk of
stillbirths
16% major malformations
2. Smoking
- Results in small for date infants
- Associated with increased hyperactivity and low
achievement
- Increases risk for placenta previa, abruption
placenta, prematurity and respiratory disease and
abortion
- In utero decrease fetal breathing movements
and increased fetal heart rate
- All of these related to decreased uterine blood flow
because of the hardened small caliber arteries due
to smoking
3. Environmental Chemicals
Lead
- Causes
fetal
growth
abnormalities
and
developmental delays
Methylmercury
- Developmental delays, microcephaly, severe
brain damage
CONCLUSIONS
- Medications should only be used if expected
benefits to mother or fetus outweigh risks.
- Avoid use in the first trimester if at all possible/
Only folic is required in first trimester

Page 6 of 9

Use extensively tested in pregnancy drugs rather

than new/untried meds.
Use minimum dose that would be beneficial to
mother
The list of proven teratogens is short but by no
means complete. More will be added as data
become available.
Discussion focuses on chemicals proven
not to have teratogenic effects
Many effects when studied are proven
later not to have a relationship with the
effect that they are suspected to cause
Absence of data does not imply safety.
Obtain accurate details of exposure:
Especially gestation age at which drugs
are taken
Check for confounding family or medical
history
Get up-to-date info on published risks of
the specific drug in humans
Emphasize
background
risks
in
counseling
Be clear about what is known but do not
assume absence of data means no risk.
IMMUNIZATION DURING PREGNANCY

General Considerations for Vaccination based on the

2011 CPG on Immunization for Filipino Women:
1. Never administer vaccines on the buttocks.
2. Confirm completion (or more recent) primary
vaccine series for measles, mumps, and rubella
(MMR); and Tetanus-Diptheria (Td) before
initiating adult recommended vaccine schedules.
3. Maintain vaccine administration record in patient
chart, including the [DR ManuLotS] date, route of
administration, manufacturer, lot number, and
site of administration.
4. Knowing the route of vaccine administration,
needle size, and vaccine storage and handling are
critical components of a quality, office-based
vaccine program.
5. Simultaneous use
contraindicated.

of

any

vaccine

is

not

6. Antibiotic therapy or breastfeeding are not

contraindications to vaccination. Likewise, in the
presence
of
a
pregnant
woman
or
immunosuppressed person in the household is
not a reason to withhold an indicated vaccine to a
family member.
7. Generally,
vaccines
that
contain
(inactivated) viruses can be given

killed
during

PI Arellano | Gagui | Galvan | Pamintuan | Timbang

PROPERTY OF AUFSOM BATCH 2017
v3.1 s2015-2016

pregnancy. Vaccines that contain live viruses

are not recommended for pregnant women.
General Contraindications to Vaccination based on the
2011 CPG on Immunization for Filipino Women:
1. Severe allergy to vaccine components.
2. Pregnancy (or if planning pregnancy within 4
WEEKS) for live attenuated vaccines.
3. Severe immune attenuation (for live attenuated
vaccines only) consultation with infectious
disease specialist is advised.
4. Moderate or severe acute illness.
5. If a live attenuated vaccine is given simultaneously
with another vaccine, a 4 WEEK separation
interval should be used between vaccinations.
TETANUS-DIPTHERIA (Td) & TETANUS-DIPTHERIAPERTUSISS (Tdap)
INDICATION RECOMMENDATION
1. Pregnant women with no previous tetanus
immunization (or with an unknown immunization
history) 3 doses Td vaccine given one month
apart starting the 2nd or 3rd trimester. Third dose
may be given post partum.
2. Pregnant women whose last Td/Tdap vaccination
was more than 10 years ago Td booster in the
2nd and 3rd trimester.
DOSE REGIMEN
Primary vaccination series: 3 Td injections IM
First 2 doses given 1 month apart
Last dose given 6-12 months after 2nd dose.
CONTRAINDICATION: Severe allergic reaction after
previous dose or to a vaccine component.
PRECAUTION:
History of Arthus-type hypersensitivity reaction following a
TT-containing vaccine Defer vaccination at least 10
years since last TT-containing vaccine.
ADVERSE REACTIONS:
Mild: (noticeable reactions but does not interfere
with daily activities)
o Pain
o Redness and/or swelling
o Mild fever
o Headache or tiredness
Moderate: (interferes with activities but does not
require medical attention)
o Fever over 102F (38.9C)
o Extensive swelling on vac site.

Page 7 of 9

Severe: (unable to perform usual activities;

requires medical attention)
o Severe swelling, pain, and redness of
the entire arm

CAUTION
Gullain-Barre Syndrome within 6 weeks of
previous dose of influenza vaccine
Moderate or severe acute illness with or without
fever

PNEUMOCOCCAL BACTERIA IMMUNIZATION

RECOMMENDED to pregnant and breast-feeding women
who are high risk for developing disease. Preferably
administered during the 2nd or 3rd trimester of pregnancy,
or before becoming pregnant.
HIGH RISK WOMEN:
Chronic Cardiovascular diseases (Congestive
Heart Failure, Valvular Heart disease)
Chronic Pulmonary Disease (Asthma, COPD,
PTB)
Sickle Cell Disease
DM / GDM
Chronic Liver Disease
Immunocompromised person
o HIV/AIDS
o Leukemias and other neoplasias
o Severe Renal Pathologies
o Transplant patients
DOSE REGIMEN: Single, 0.5mL IM/SQ
CONTRAINDICATIONS:
Hypersensitivity
Severely
compromised
Cardiovascular
or
Pulmonary function
Children <2 years of age (No established safety
and efficacy for this age group)
ADVERSE REACTIONS:
Mild: (common)
o Local erythema and tenderness or
swelling
o Low grade fever
Severe: (rare)
INFLUENZA VIRUS IMMUNIZATION
TARGET POPULATION:
1. All pregnant and breast feeding women =
inactivated flu vaccine.
2. Individuals belonging to the following HIGH RISK
group:
a. Children 6mos to 18y/o
b. Elderly aged 50y/o and above
c. People at risk for medical complications
and their contacts
d. ALL health care providers
CONTRAINDICATED in patients with severe allergic
reactions after previous dose, or to the egg protein
component of the vaccine.

PI Arellano | Gagui | Galvan | Pamintuan | Timbang

PROPERTY OF AUFSOM BATCH 2017
v3.1 s2015-2016

Vaccines recommended for women BUT NOT during

pregnancy:
1.
2.
3.
4.
5.
6.

Human Papilloma Virus

Varicella
MMR
Influenza (Live Attenuated type)
Zoster
BCG

Vaccines that may be used in HIGH RISK pregnant

patients:
1. HEPATITIS B
Pregnancy is not a contraindication to vaccination.
Available vaccines contain noninfectious HBsAg
and should cause no risk of infection to the fetus.
Limited data suggest that developing fetuses are
not at risk for adverse events when hepatitis B
vaccine is administered to pregnant women.
2. HEPATITIS A
An inactivated vaccine is recommended if another
high risk condition or other indications are present.
3. RABIES
Pregnancy is not a contraindication for
postexposure prophylaxis because of the potential
consequences of inadequately managed rabies
exposure. Certain studies have indicated no
increased incidence of abortion, premature births,
or fetal abnormalities associated with rabies
vaccination.
Prenatal Screening
Pregnant women should be evaluated for
immunity to rubella and varicella and be tested
for the presence of HBsAg during every
pregnancy.

Women susceptible to rubella and varicella

should be vaccinated immediately after delivery.

A woman found to be HBsAg positive should be

monitored carefully to ensure that the infant
receives HBIg and begins the HEPATITIS B
vaccine series no later than 12 hours after birth
and that the infant completes the recommended
hepatitis B vaccine series on schedule.

Passive Immunization During Pregnancy

No known risk exists for the fetus from passive
immunization of pregnant women with immune globulin
preparations.

Page 8 of 9

Breast Feeding and Vaccination

Neither inactivated nor live virus vaccines
administered to a lactating woman affects the
safety of breast feeding for women or their infants
Breastfeeding is a contraindication for SMALL
POX vaccination
Yellow fever vaccine SHOULD BE AVOIDED in
breastfeeding women
References:
1. Clinical Practice Guidelines on Immunization for
Filipino Women, Nov 2011
2.

CDC. Advisory Committee on Immunization

Practices (ACIP) recommended immunization
schedules for persons aged 0 through 18 years and
adults aged 19 years and older United States, 2013
MMWR 2013, 62 (Suppl 1): 11, CDC

3.

CDC. General recommendations on immunization:

recommendations of the Advisory Committee on
Immunization Practices (ACIP), MMWR 2011, 60
(No.2) 26-27

For more information on TERATOLOGY:

http://www.teratology.org/index.asp

Appendix:

PI Arellano | Gagui | Galvan | Pamintuan | Timbang

PROPERTY OF AUFSOM BATCH 2017
v3.1 s2015-2016

Page 9 of 9