European Journal of Obstetrics & Gynecology and

Reproductive Biology 138 (2008) 135140

www.elsevier.com/locate/ejogrb

Comparing two dinoprostone agents for cervical ripening

and induction of labor: A randomized trial
Anna Maria Marconi a,*, Patrizia Bozzetti a, Alberto Morabito b, Giorgio Pardi a
a
Department of Obstetrics & Gynecology, DMSD San Paolo, University of Milano, Via A. di Rudini 8, 20142 Milano, Italy
b
Department of Statistics, DMSD San Paolo, University of Milano, Via A. di Rudini 8, 20142 Milano, Italy
Received 16 July 2006; received in revised form 6 August 2007; accepted 8 August 2007

Abstract

Objective: To compare dinoprostone gel and insert in achieving successful vaginal delivery in nulliparous and multiparous women.
Study design: 220 nulliparous and 100 multiparous with a Bishop score 7 were randomized to receive dinoprostone either gel or insert for
cervical ripening. The main outcome measures were the rate and latency of vaginal delivery.
Results: In nulliparous women no significant differences were found between the gel and insert groups in the rate of vaginal delivery (85.6%
vs. 80.7%) delivery 12 (36.8% vs. 32.9%) and 24 h (85.3% vs. 93.4%) regardless of the preinduction Bishop score. Nulliparous with
Bishop score 4 treated with the insert had a decreased risk ( p < 0.05) of post partum hemorrhage (4.8%) when compared with nulliparous
treated with gel (16.7%). On the contrary, in multiparous the time to delivery interval was significantly shorter in the gel treated group
(9.9  4.9 h vs. 13.1  5 h; p < 0.001) with more patients delivering vaginally 12 h (75% vs. 37.5%, p < 0.001), regardless of the
preinduction Bishop score.
Conclusion: Both dinoprostone gel and insert are efficient in achieving cervical ripening and successful labor in nulliparous and multiparous.
In multiparous, however, the gel significantly reduces the time to vaginal delivery with more patients delivering vaginally 12 h, regardless of
the Bishop score.
# 2007 Elsevier Ireland Ltd. All rights reserved.

Keywords: Induction of labor; Dinoprostone; Parity

1. Introduction However, most comparative randomized clinical trials

Labor induction is among the most frequent procedures
performed in pregnant women and many studies have
demonstrated that cervical ripeness is one of the most
important factors in predicting successful labor induction
[1]. Thus far, prostaglandins, particularly PGE, have been
shown to be the most effective agents in achieving cervical
ripening [1]. The effects and properties of PGE2
(dinoprostone) have been extensively investigated and
many studies have compared the efficacy of the different
formulations available (gel vs. slow release insert) [212].
Preliminary account of this work was presented at the 2003 Annual
Meeting of the Society for Gynecologic Investigation, Washington, DC.
* Corresponding author. Tel.: +39 02 503 23064; fax: +39 02 936 50639.
E-mail address: annamaria.marconi@unimi.it (A.M. Marconi).
have not drawn definitive conclusions about the relative
effectiveness with regard to parity [2,3,6]. Furthermore, in
most studies the induction regimen is not comparable: the
slow release dinoprostone insert is either repeated or
followed by gel administration, if labor does not start [5,9
12]. Similarly, for the dinoprostone gel the variability,
among studies, concerns both dose and administration
route [3,69].
The purpose of our prospective randomized study was
to compare the efficacy of dinoprostone gel and insert in
promoting cervical maturation and achieve vaginal
delivery. Results are presented in terms of route of
delivery, induction latency and maternal and neonatal side
effects in nulliparous (N) and multiparous (M) patients,
analyzed separately, and according to the preinduction
Bishop score.

0301-2115/$ see front matter # 2007 Elsevier Ireland Ltd. All rights reserved.
doi:10.1016/j.ejogrb.2007.08.009
136 A.M. Marconi et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 138 (2008) 135140
2. Materials and methods
This prospective randomized study was performed at the
Department of Obstetrics and Gynecology, DMSD San
Paolo, University of Milano (Italy). The Department Board
approved the protocol. Written informed consent was
obtained from all pregnant women.
The study took place from June 2001 to March 2003 and
all women requiring induction of labor were evaluated for
entry into the study. Inclusion criteria were: (1) Bishop score
7; (2) gestational age 37 weeks; (3) singleton pregnancy;
(4) no previous uterine surgery and (5) absence of
contraindications to vaginal delivery. Gestational age was
calculated from the last menstrual period and confirmed by
routine sonography at 20 weeks gestation.
320 patients met the inclusion criteria (220 nulliparous
and 100 multiparous) and were randomly assigned by means
of a phone call randomization with stratification by parity to
receive dinoprostone either gel (Prepidil 0.5 intracervical or
1 mg intravaginal, Pharmacia Italia S.p.A., Milano, Italy) or
insert (Propess 10 mg, Ferring S.p.A., Milano, Italy).
Patients randomized to the gel received 0.5 mg intra-
cervical when the Bishop score was 4 or 1 mg intravaginal
when the Bishop score was 57 with a maximum of three
doses, 6 h apart if spontaneous labor had not occurred or the
Bishop score was 7.
Patients randomized to the vaginal insert received the
10 mg controlled-release dinoprostone insert as a single dose:
the insert was removed after 12 h if labor had not started.
Either PB or AMM assessed the initial Bishop score (BS):
the attending physician performed subsequent management.
In each patient, the fetal heart rate and uterine activity
were recorded continuously for at least 30 min prior to
dinoprostone administration and for at least 60 min after. If
active labor (regular uterine contractions occurring every 2
3 min) started during the ripening phase, no further gel dose
was administered or the insert was removed, according to the
allocation group.
Amniotomy and/or oxytocin was performed: (a) in the gel
group, during the preinduction period when the BS was >7;
(b) in both groups, if active labor did not start at the end of
the preinduction period regardless of the BS; in these
patients it was performed 69 h after the last dose of gel or
30 min to 3 h after the removal of the insert (this 3 h delay
was dependent on the activity of the labor and delivery ward)
and (c) in patients in labor for augmentation when cervical
dilatation, assessed every 2 h, had not increased by at least
2 cm in nulliparous and 3 cm in multiparous, according to
our local protocol.
Treatment failure, as in (a) and (b), was considered when
the patient was not in labor after at least 6 h of oxytocin
administration. Uterine tachysystole was diagnosed when
more than five contractions were present in 10 min for at
least 20 min [13].
Oxytocin was begun at 2 mU/min and doubled every
15 min up to 16 mU/min when the increase was of 2 mU
every 15 min up to a maximum dose of 32 mU/min.
Amniotomy was performed simultaneously, before or after,
at the discretion of the attending clinician.
Abnormal fetal heart rate was defined by the presence of
persistent severe variable decelerations, persistent late
decelerations or bradicardia with absent variability [14].
Maternal blood loss was assessed with a plastic bag
with a graded funnel-shaped tube (Biogyn s.n.c., Mirandola
MO, Italy).
For a beta of 0.10 and an alpha of 0.05 and a rate of
cesarean delivery in the gel and insert groups of 1234%, 84
patients were required in each group. Analysis was by intent
to treat. Data are presented as mean  S.D. and median
when appropriate. Coxs proportional hazard model was
used to evaluate the impact of treatment, parity and
preinduction Bishop score on the time to vaginal delivery
interval. Proportional hazard assumptions were graphically
tested. KaplanMeier estimates of the mean time to vaginal
delivery were performed. The differences between Kaplan
Meier curves were tested by the log-rank test. Differences
between means were analyzed with a Students t test for
unpaired samples whereas proportional data were analyzed
by Fishers two tailed exact test using Statistica for
Windows. p-Values <0.05 were considered significant.
3. Results
320 women were randomized: 161 in the gel group (111
N and 50 M) and 159 in the insert group (109 N and 50 M).
Table 1 presents maternal age, gestational age and Bishop
score at the beginning of induction in the two groups
according to parity. No significant differences were present.
Indications for labor induction included: oligohydram-
nios (amniotic fluid index 5); prelabor rupture of the
membranes (PROM); post-date pregnancy (41 weeks + 3
days); intrauterine growth restriction (IUGR: diagnosed
when fetal abdominal circumference was below the 10th
percentile; only cases with umbilical Doppler waveforms
within the normal range were included); gestational
hypertension and gestational diabetes; non-reassuring
CTG; other maternal indications including thrombophilia,
cholestasis, psychological indication, fever (Table 1). The
time interval between PROM and the beginning of the
cervical ripening was not different in the gel (12.4  2.8 h)
and insert (12.8  1.9) groups ( p = 0.5).
In the insert group, there were 15 accidental expulsions
(between 2:45 and 11:40 h after application) and in 4
nulliparous, since active labor did not already start, it was
reapplied. In the nulliparous patients the insert was removed
after 8.32  4.01 h with a significant increase of the BS
(6.5  1.9; p < 0.001 vs. BS at induction); similarly, in the
multiparous patients it was removed after 9.2  4.48 h with
a significant increase of the BS (7.4  0.3; p < 0.001 vs. BS
at induction). The number of vaginal examinations
performed to complete the preinduction process was
 A.M. Marconi et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 138 (2008) 135140 137

Table 1
Maternal age, gestational age and Bishop score at the time of induction
(mean  S.D.) and clinical indication for induction
Gel Insert
Number of patients 161 159
Nulliparous 111 (68.9%) 109 (66.7%)
Multiparous 50 (31.1%) 50 (33.3%)
Maternal age (years) 31  4.7 30.3  5.1
Nulliparous 30.05  4.3 29.4  4.7
Multiparous 33.1  4.9 32.1  5.6
Gestational age (weeks) 39.6  1.3 39.6  1.4
Nulliparous 39.6  1.4 39.6  1.4
Multiparous 39.7  1.3 39.8  1.3
Fig. 1. KaplanMeier plot of time to vaginal delivery stratified by parity
Bishop score at induction 4.1  1.2 4.0  1.1 and treatment group in patients with Bishop score 4 (solid line: M with
Nulliparous 3.9  1.1 3.9  1.2 gel; hatched line: M with insert; solidhatched line: N with gel; dotted line:
Multiparous 4.5  1.1 4.1  1.1 N with insert).
Parity
Nulliparous at first pregnancya 87 (78.4%) 85 (78%) (4.9%) nulliparous had vacuum assisted vaginal delivery
Multiparous with >1 delivery 14 (28%) 9 (18%) regardless of preinduction Bishop score or treatment. The %
Indication for induction
of cesarean section was higher, although not significant, in N
Oligohydramnios 41 35 and M with unfavourable cervix with no treatment based
Premature rupture of membranes 33 22 differences. Overall, only three cesarean sections were
Postdate pregnancy 22 30 performed for failed induction, all in nulliparous with BS
Gestational hypertension 21 24 4 (one in the gel and two in the insert groups).
Intrauterine growth restriction 17 17
Gestational diabetes 9 8
27 patients (25 of which nulliparous) had a 0 change of
Non-reassuring CTG 6 6 BS at the end of the preinduction period (22 in the insert and
Other maternal medical conditions 12 16 5 in the gel group): even though 16/27 remained with a BS
a
Absence of spontaneous or voluntary pregnancy termination.
4, amniotomy/oxytocin was performed and 21/27 deliv-
ered vaginally (15 within 24 h). Only six cesarean sections
were performed in these patients, two for failed induction
significantly higher in the gel than in the insert groups (both in nulliparous).
(1.9  1.04 vs. 1.3  0.5; p < 0.001). At vaginal delivery, we found no differences in the mean
Two patients in the gel group and two patients in the blood loss (273  230 ml in the gel group and 253  232 in
insert group had complications. In the insert group, uterine the insert group), however more patients with an unfavour-
tachysystole with abnormal fetal heart rate tracings able cervix in the gel treated group had a post partum
developed within 2 h from induction, the ripening agent hemorrhage (PPH) and this was mainly due to nulliparous.
was removed and, after the fetal heart rate had recovered, The median hospital stay was not different in the gel and
amniotomy was performed and both patients delivered insert groups (4 days) regardless of parity: 26/30 patients in
vaginally after approximately 3 and 5 h, respectively. In the the gel group and 26/35 in the insert group with a hospital
gel group, one multiparous patient had uterine tachysystole stay >4 days had an unripe cervix (BS  4) (Table 3).
with abnormal fetal heart rate: vaginal washing was
performed, fetal heart rate recovered and she delivered
vaginally approximately after 4 h. In the other patient, fetal
heart rate abnormalities appeared with no evidence of
uterine tachysystole: she underwent a cesarean section and
the umbilical cord was found having two true knots.
No maternal side effects (nausea, vomiting, fever and
diarrhea) were reported in any patient.
Time to vaginal delivery is presented as a KaplanMeier
plot stratified by parity and treatment in Fig. 1 (patients with
Bishop score 4) and Fig. 2 (Bishop score 57). When Coxs
regression analysis was performed we found that the time to
vaginal delivery interval was independently correlated to
treatment ( p < 0.02), parity ( p < 0.001) and preinduction
Fig. 2. KaplanMeier plot of time to vaginal delivery stratified by parity
Bishop score ( p < 0.001) (Table 2). Multiparous with BS 57 and treatment group in patients with Bishop score 57 (solid line: M with
treated with gel had the shortest time to delivery interval gel; hatched line: M with insert; solidhatched line: N with gel; dotted line:
(Table 3); no differences were present in nulliparous. 9/183 N with insert).
138 A.M. Marconi et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 138 (2008) 135140

Table 2
Cox regression analysis
Hazard ratio Standard error z p > [z] [95% Confidence interval]
Treatment 0.7706115 0.0883825 2.27 0.023 0.6154744 0.9648527
Parity 2.002239 0.2592057 5.36 0.000 1.553535 2.580541
Bishop score 2.034914 0.2627192 5.50 0.000 1.579978 2.620844

Neonatal outcome is presented in Table 4: there were no
differences in the mean birthweight and in the percentage of
babies 2500 grams between the gel and insert treated
patients. 19 babies were admitted in the NICU, only 5 of
which for delivery related problems.
4. Comment
This is the largest prospective randomized study
comparing two dinoprostone agents, gel and insert, in
achieving cervical ripening and successful delivery in
nulliparous and multiparous patients analyzed separately.
We studied 320 patients, mostly (68.7%) nulliparous.
Our protocol does not allow more than one insert
application (unless accidentally removed before the start
of uterine contractions with a BS < 7) and more than three
administration of gel: intracervical vs. intravaginal route is
dependent on the BS, based upon the observation that
intracervical administration is particularly effective when
the cervix is unfavourable (BS  4) [15]. As a matter of
fact, 34% of the nulliparous and 44% of the multiparous
with an unripe cervix went into labour after the first
intracervical gel.
Furthermore, once in progress, the preinduction is
brought until delivery has been accomplished; amniotomy
and/or oxytocin is started either when the BS is >7 or when
regular uterine contractions are not present at the end of the
ripening process, independent of the BS. Other authors
chose to repeat the preinduction after 24 h if labor did not
start or the BS did not improve [5,912] even though the
ripening process should determine changes in histologic
characteristics and biochemical composition of the cervix
which not necessarily imply the onset of uterine contractions
[16]. These authors report repetition of induction rates
varying from 3% (10) to 53% (9) with the insert and from
16% (10) to 34% (9) with the gel without any evident benefit.
In our study, >80% of the patients delivered vaginally
regardless of parity, treatment and preinduction BS. Other
authors have reported similar high rate both for the insert
[2,5,7,8] and the gel [5,7,8,17]. However, when compared to
other studies, we report higher rates of vaginal delivery
within 12 h regardless of parity [10,17], treatment
[6,10,11,17] or preinduction BS [11,12]: this was mainly

Table 3
Data at delivery and hospital stay according to parity and to the Bishop score at the time of induction in the gel and insert groups
BS  4 p BS 57 p
Gel Insert Gel Insert
Number of patients (%) 111 (68.9%) 109 (68.6%) NS 50 (31.1%) 50 (31.4%) NS
Nulliparous 87 (78.4%) 80 (73.4%) 24 (48%) 29 (58%)
Multiparous 24 (21.6%) 29 (26.6%) 26 (52%) 21 (42%)
Vaginal delivery (%) 96 (86.5%) 89 (81.6%) NS 48 (96%) 47 (94%) NS
Nulliparous (% of N) 72 (82.8%) 62 (77.5%) 23 (95.8%) 26 (89.7%)
Multiparous (% of M) 24 (100%) 27 (93.1%) 25 (96.1%) 21 (100%)
Hours from induction to VD 15.3  7.7 15.6  7.1 NS 9.6  4.4 12.3  4.9 0.006
Nulliparous 16.5  8 16.1  7.7 11.5  4.8 12.9  5.6
Multiparous 11.9  5.7 14.5  5.5 7.8  3.1 11.5  3.8 0.001
Cesarean section 15 (13.5%) 20 (18.3%) NS 2 (4%) 3 (6%) NS
Nulliparous (% of N) 15 (17.2%) 18 (22.5%) 1 (4.2%) 3 (10.3%)
Multiparous (% of M) 0 2 (6.9%) 1 (3.8%) 0
Amniotomy/Oxytocin for induction 45 (40.5%) 43 (39.4%) NS 7 (14%) 10 (20%) NS
Nulliparous (% of N) 36 (41.4%) 35 (43.8%) 5 (20.8%) 6 (20.7%)
Multiparous (% of M) 9 (37.5%) 8 (27.6%) 2 (7.7%) 4 (19%)
Post partum hemorrhage (500 ml)a 14 (14.6%) 4 (4.5%) 0.03 6 (12.5%) 7 (15.2%) NS
Nulliparous (% of N) 12 (16.7%) 3 (4.8%) 0.05 3 (13%) 6 (23.1%)
Multiparous (% of M) 2 (8.3%) 1 (3.7%) 3 (12%) 1 (4.8%)
Hospital stay >4 days 26 (23.4%) 27 (24.8%) NS 3 (6%) 9 (18%) NS
Nulliparous 25 (28.7%) 23 (28.7%) 3 (12.5%) 7 (24.1%)
Multiparous 1 (4.2%) 4 (13.8%) 0 2 (9.5%)
a
At vaginal delivery.
 A.M. Marconi et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 138 (2008) 135140
Table 4
Birthweight, and neonatal outcome in the study groups
Gel
Birthweight (grams) [range] 3238  475 [17804300]
Nulliparous 3204  463
Multiparous 3316  495
Birthweight 2500 g 13 (8.1%)
Cesarean section for fetal heart rate abnormalities 9 (5.6%)
0
Apgar  7 at 1 7 (4.3%)
Apgar  7 at 50 1 (0.6%)
Umbilical arterial pH < 7.00 1a (0.6%)
Meconium stained amniotic fluid
Transfer to neonatal intensive case unit 8 (5%)
For delivery related problems 3 (1.9%)
a
Delivered by vacuum.
due to multiparous treated with gel, independently of the
Bishop score. Similarly, almost 90% of the patients who
delivered vaginally, delivered within 24 h regardless of
parity and this is the highest percentage reported thus far in
similar studies. Also, the time to delivery interval is shorter
in our study when compared to others both in the gel [2,5]
and insert [2,18] groups. Both observations might be
partially explained by the fact that others allowed repetition
of the preinduction [5,11,12] which most likely has
lengthened the whole process. However, it is worth noting
that the rate of vaginal delivery within 24 h is higher also
than that reported by Stewart et al. [17] in a gel group treated
with immediate oxytocin (76% in nulliparous and 89% in
multiparous) and by Bolnik et al. [19] in an insert group
treated with immediate oxytocin (81%).
Conversely, we had a low cesarean section rate,
particularly in multiparous (2% in the gel group and
4% in the insert group), regardless of the BS. Even though
this study is underpowered to detect the cesarean section
rate differences, we found (to achieve a significant result
we should have enrolled 1555 patients in each arm) the
cesarean section rate in these patients is comparable with
rates obtained in low risk patients in spontaneous labour at
our institution (13.7%). A possible explanation for this is
the large use of amniotomy/oxytocin: on the whole, 63%
of our patients received either further induction or
augmentation and this might have increased the number
of successful vaginal delivery on one side, and reduced the
number of cesarean section for failed induction on the
other side.
Nulliparous with an unfavorable cervix treated with gel
had an increased rate of post partum blood loss 500 ml
when compared to insert treated women. Even though
induction of labor with PGE2 has been reported as a risk
factor for PPH when compared to placebo [1], to our
knowledge this is the first time a difference among
treatments is reported. We do not have a clear explanation
for this finding: in both groups patients received the same
prophylaxis (oxytocin 10 iu im) and there were no
139
Insert p
3286  509 [19304630] NS
3259  489
3346  551
9 (5.7%) NS
6 (3.8%) NS
6 (3.8%) NS
1 (0.6%)
1a (0.6%) NS
3 (1.9%) NS
11 (6.9%) NS
2 (1.2%)
differences in operative vaginal delivery, rate of oxytocin
augmentation or other post partum complications.
We are aware that misoprostol is much more cost-
effective (same efficacy with very low costs) however its use
is still associated with the observation of significant side
effects [2022]. Furthermore, compared to the results of our
study it does not seem to offer big advantages in terms of
cesarean section rate and time to delivery intervals [19,23]
even though only a randomized trial could confirm this
observation.
In conclusion, our study shows that both dinoprostone gel
and insert are efficient in achieving cervical ripening and
successful vaginal delivery both in nulliparous and multi-
parous with negligible maternal and fetal/neonatal side
effects. In multiparous, however, the gel significantly and
correctly powered reduces the time to vaginal delivery with
more patients delivering vaginally within 12 h, regardless of
the Bishop score. The insert seems more convenient in
nulliparous patients, especially when the preinduction BS is
4, given its handiness: one administration, possible
application overnight, easy removal in case of side effects,
less vaginal examinations and, most important, decreased
risk of post partum hemorrhage.
Acknowledgments
The authors wish to thank Camilla De Gasperi, MD,
Maria Nobile De Santis, MD and Simona Vailati, MD for
their precious help in collecting the data forms.
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