Original Research
Misoprostol With Foley Bulb Compared With
Misoprostol Alone for Cervical Ripening
A Randomized Controlled Trial
Zainab Al-Ibraheemi, MD, Lois Brustman, MD, Brianne E. Bimson,
and Barak Rosenn, MD
OBJECTIVE: To test the hypothesis that cervical ripening
using a combination of misoprostol and a transcervical
Foley bulb leads to delivery within a shorter time
compared with misoprostol alone.
METHODS: This randomized controlled trial was
offered to women admitted for cervical ripening. Inclu-
sion criteria were gestational age 37 weeks or greater
with intact membranes, singleton fetus, cephalic pre-
sentation, and Bishop score 6 or less. Exclusion criteria
included, among others, prior uterine surgery, ruptured
membranes, and any contraindication to vaginal delivery.
Patients were randomized to cervical ripening using
misoprostol and a transcervical Foley bulb simulta-
neously or misoprostol alone. Primary outcome was time
from placement of the misoprostol to delivery. Second-
ary outcomes included time to active phase, time from
active phase to delivery, cesarean delivery rate, uterine
tachysystole, estimated blood loss, chorioamnionitis,
cord pH, 5-minute Apgar score, and neonatal intensive
care unit admission. Sample size calculation revealed
that 94 participants were required in each group to
detect a 3-hour difference with 80% power and a error
of 0.05. Intention-to-treat analysis was performed.
RESULTS: From September 2015 to July 2016, a total of
200 patients were randomized, 100 to each group. There
From the Department of Obstetrics and Gynecology, Mount Sinai West Hospital,
New York, New York.
Presented at the Society for Maternal-Fetal Medicine’s 37th Annual Pregnancy
Meeting, Las Vegas, Nevada, January 23–28, 2017.
Each author has indicated that he or she has met the journal’s requirements for
authorship.
Corresponding author: Zainab Al-Ibraheemi, MD, Department of Obstetrics and
Gynecology, Mount Sinai West Hospital, 1000 10th Avenue, Suite 10C, New
York, NY 10019; email: zainabqalibraheemi@gmail.com.
Financial Disclosure
The authors did not report any potential conflicts of interest.
© 2017 by The American College of Obstetricians and Gynecologists. Published
by Wolters Kluwer Health, Inc. All rights reserved.
ISSN: 0029-7844/18
VOL. 131, NO. 1, JANUARY 2018
Copyright ª by The American College of Obstetricians
and Gynecologists. Published by Wolters Kluwer Health, Inc.
Unauthorized reproduction of this article is prohibited.
MD, Natalie Porat, MD,
were no differences between groups with respect to
parity, body mass index, gestational age, Bishop score,
birth weight, or indication for induction. Time to delivery
was significantly shorter in the combined misoprostol–
transcervical Foley group: 15.0 (11.0–21.8) hours
(median [interquartile range]) vs 19.0 (14.0–27.3) hours in
the misoprostol-only group (P5.001). This time differ-
ence remained significant after subanalysis by parity or
after excluding cesarean deliveries. There was no differ-
ence between groups with respect to the rate or indica-
tion for cesarean delivery, estimated blood loss, rate of
tachysystole, chorioamnionitis, or neonatal outcomes.
CONCLUSION: Cervical ripening using misoprostol in
combination with a transcervical Foley bulb is an effec-
tive method to shorten the course of labor compared
with misoprostol alone.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov,
NCT02566005.
(Obstet Gynecol 2018;131:23–9)
DOI: 10.1097/AOG.0000000000002403
A pproximately 25% of all births in the United
States follow induction of labor,1,2 and ripening
of an unfavorable cervix often becomes an integral
part of this process.3 There are various medical and
mechanical methods of cervical ripening and several
studies have attempted to compare these methods in
an effort to determine the optimal approach.
A few studies have compared cervical ripening
using the combination of misoprostol with a trans-
cervical Foley bulb (hereafter referred to as “Foley
bulb”) with misoprostol alone, but these studies have
mixed results. Although Carbone et al4 found that
combining misoprostol with a Foley bulb shortens
the mean induction to delivery time by 3 hours com-
pared with using misoprostol alone, other investiga-
tors5,6 found no advantage in using the combination
of misoprostol with a transcervical balloon.
OBSTETRICS & GYNECOLOGY 23
 Given these contradicting results and the ubiqui-
tous practice of induction of labor, we sought to
provide additional high-quality data to help resolve
this issue. The purpose of our study was to test the
hypothesis that cervical ripening using a combination
of misoprostol with a Foley bulb would lead to
delivery within a shorter time compared with miso-
prostol alone.
MATERIALS AND METHODS
This was a randomized controlled trial that was
offered to women admitted for cervical ripening and
induction of labor from September 30, 2015, to July
14, 2016. The study was approved by the institutional
review board (#15-0032) at Mount Sinai West Hospi-
tal in August 2015 and was registered in Clinical-
Trials.gov (NCT02566005).
The study was offered to women at term (37
weeks of gestation or greater) with a singleton fetus,
cephalic presentation, and a Bishop score of 6 or less.
Exclusion criteria included rupture of membranes,
regular uterine contractions (three or more contrac-
tions per 10 minutes), a history of prior uterine
surgery (cesarean delivery or myomectomy), multiple
gestations, malpresentation, contraindication to pros-
taglandins, nonreassuring fetal heart rate tracing
(category 3 or persistent category 2), vaginal bleeding,
fetal demise, anomalous fetus, or any contraindication
to vaginal delivery.
Patients who were admitted to the labor and
delivery unit for induction of labor were assessed for
eligibility and approached to participate in the study.
Informed consent was obtained and signed by the
patient and investigator. Patients were randomized to
cervical ripening using misoprostol and Foley bulb
simultaneously or misoprostol alone. Randomization
was achieved through a computer-generated assign-
ment that used simple randomization with one-
to-one allocation for each arm of the study. The
allocation of assignment was concealed by placement
in sequentially numbered, opaque, sealed envelopes
that were drawn in consecutive order. Participants,
health care providers, and investigators were not
blinded or masked to the group allocation after
randomization.
Women who were randomized to the misoprostol-
only group received 25 micrograms of misoprostol (100-
microgram tablet cut into fourths by the hospital
pharmacist) inserted vaginally into the posterior fornix
every 4 hours and repeated up to a maximum of six
doses per our standard hospital protocol. Once the
cervix became favorable (Bishop score greater than 6) or
if the patient was in active labor (defined as cervical
24 Al-Ibraheemi et al Misoprostol Ripening With or Without Foley
Copyright ª by The American College of Obstetricians
and Gynecologists. Published by Wolters Kluwer Health, Inc.
Unauthorized reproduction of this article is prohibited.
dilation 6 cm or greater), or if there was no progress for
24 hours as judged by patient’s health care provider,
misoprostol administration was discontinued and further
management was at the discretion of the patient’s health
care provider.
Women randomized to the combination group
(misoprostol with transcervical Foley bulb) received
vaginal misoprostol as described previously for the
misoprostol-only group and in addition, a Foley
catheter with a 30-cc balloon was inserted digitally
or by direct visualization with the use of a sterile
speculum. The Foley catheter was inserted through
the internal os and the balloon was filled with 60 cc of
normal saline.7 The catheter was taped to the patient’s
inner thigh under gentle traction.8 If the Foley cathe-
ter was unable to be inserted on the initial attempt,
another attempt was performed after 4 hours with
placement of the second dose of misoprostol. Once
the Foley bulb was spontaneously expelled, further
management of labor was at the discretion of the
health care provider. Foley balloons that were not
spontaneously expelled were deflated and removed
after 24 hours.
Oxytocin was initiated in all patients who did not
have at least three regular contractions in 10 minutes 4
hours after placement of the last misoprostol dose.
The oxytocin was administered by an infusion pump
system beginning at 2 milliunits/min and increased by
2 milliunits/min every 30 minutes until regular con-
tractions were established with three to five contractions
in each 10-minute interval. Continuous fetal heart rate
monitoring and uterine activity monitoring were per-
formed in all patients. Amniotomy was performed
during the course of labor at the discretion of the health
care provider and epidural anesthesia was administered
per the patient’s request.
The primary outcome was time from placement
of the first misoprostol dose to delivery. Secondary
outcomes included time to active phase (defined as
dilation 6 cm or greater), time from active phase to
delivery, cesarean delivery rate, uterine tachysystole
(defined as greater than five contractions in a 10 min-
ute-interval averaged over 30 minutes),9 estimated
blood loss estimated visually by the health care pro-
vider, chorioamnionitis (diagnosed clinically), cord
blood pH, 5-minute Apgar score, and neonatal inten-
sive care unit admission.
Previous studies have shown that the mean
induction to delivery time using misoprostol is 1868
hours,4–6,10 similar to data from our own hospital.
One randomized study4 showed a mean induction
to delivery time 3 hours shorter using the combina-
tion of Foley bulb and misoprostol as compared with
OBSTETRICS & GYNECOLOGY
misoprostol alone. We calculated that to achieve 80%
power to detect a difference of 3 hours between the
mean induction to delivery times of the two groups,
a total of 188 patients (94 in each group) would need
to be randomized using a two-sided t test and accept-
ing an a error of 0.05. Statistical analyses were per-
formed based on intention to treat. Student t test,
Fisher exact test, and Wilcoxon rank-sum test were
used as appropriate.
RESULTS
During the study period from September 30, 2015, to
July 14, 2016, 4,767 patients delivered at our institu-
tion and of these, 1,423 deliveries (29%) followed
induction of labor. Women undergoing induction of
labor were approached when study personnel were
available, and a total of 200 patients consented to
participate in the study and were randomized, 100 to
each group. Ninety-four of 100 patients assigned to
the combination group received the allocated inter-
vention; six patients did not receive the assigned
treatment because they either were in labor after
randomization or had vaginal bleeding. Only one
patient in the combination group did not get the Foley
as a result of difficulty inserting the catheter. Among
the 100 patients in the misoprostol-only group, 92
patients received the assigned allocation; eight pa-
tients received a Foley bulb after randomization
during labor in addition to misoprostol per health
care provider preference (Fig. 1).
There was no difference between groups with
respect to parity, body mass index, gestational age,
race, Bishop score, or indication for induction
(Table 1). More patients in the misoprostol group
received more than one dose of misoprostol (Table 2).
The primary outcome, time to delivery, was
significantly shorter in the combined misoprostol–
Foley group: 15.0 (11.0–21.8) hours (median [inter-
quartile range]) vs 19.0 (14.0–27.3) hours in the
misoprostol-only group (P5.001). This time differ-
ence remained significant after subanalysis by parity
or after excluding cesarean deliveries (Table 3).
There were no differences between groups with
respect to the rate or indications for cesarean deliv-
ery, total estimated blood loss, chorioamnionitis, or
rate of tachysystole (Table 4). Regarding neonatal
outcome, there was no difference between groups
with respect to venous cord pH, birth weight, 5-min-
ute Apgar score, and neonatal intensive care unit
admission. There was a higher rate of meconium
stained amniotic fluid in the misoprostol-only group
compared with the combined misoprostol–Foley
group (P5.025) (Table 5).
In addition to intent-to-treat analysis, the analyses
were repeated using actually treated. Median time
from induction to delivery was again significantly
shorter in the combined misoprostol–Foley group
(n594) vs the misoprostol-only group (n592): 16.0
(11.0–22.0) hours (median [interquartile range]) vs
18.9 (13.8–26.4), respectively (P5.009; Table 3).

Fig. 1. Trial flowchart.

Al-Ibraheemi. Misoprostol Ripening With or Without Foley. Obstet Gynecol 2018.

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Table 1. Patient Characteristics true whether analysis was performed by intention to
treat or per actual treatment or after excluding
Misoprostol Misoprostol patients who had cesarean delivery. Time from
Group +Foley Group induction to active phase of labor (but not from active
Characteristic (n5100) (n5100)
phase to delivery) was also significantly shorter in the
Age (y) 31.565.9 31.866.3 combination group. These findings suggest that the
BMI (kg/m2) 31.866.8 31.2265.7 value of the misoprostol–Foley combination lies in its
Parity ability to speed the process of cervical ripening
0 74 70
1 or greater 26 30
toward entering the active phase of labor. Although
Race there were no differences between groups with respect
White 29 26 to the rate of or indication for cesarean delivery, total
Black 19 21 estimated blood loss, chorioamnionitis, or neonatal
Hispanic 39 38 outcomes (except for a higher rate of meconium-
Asian 6 9
Others 7 6
stained amniotic fluid in the misoprostol group), our
Gestational age at 39.461.4 39.661.3 study was underpowered to address these outcomes.
delivery (wk) We also analyzed our results after excluding
Indication for induction patients who did not reach the active phase of labor
Oligohydramnios or 21 22 and again found that time to delivery was 3.5 hours
polyhydramnios
Post due date 21 21
shorter in the combined group. Because time to
Hypertensive 28 20 delivery in these patients could be skewed by timing
disorder of the physician’s decision to proceed with cesarean
Gestational diabetes 11 11 delivery, it was important to demonstrate that our
or diabetes results held true after excluding the patients who did
Advanced maternal 1 4
age
not reach the active phase.
Other 18 22 More patients in the misoprostol group required
Bishop score at 2.0 (1.25–4.0) 3.0 (2.0–4.0) more than one dose of misoprostol compared with the
misoprostol combined group. Clinically, according to our hospital
placement protocol, additional doses of misoprostol are withheld
Insurance
Private 59 53
if the patient is contracting more than three contrac-
Service 41 47 tions in 10 minutes. Thus, the combination of
BMI, body mass index.
misoprostol with Foley bulb likely led to increased
Data are mean6SD, n, or median (interquartile range). uterine activity and possibly to earlier administration
of oxytocin. We did not analyze the duration of
oxytocin administration, but regardless, the end result
There were 20 patients in the misoprostol group
was a shorter course of labor without an increased risk
and 18 in the combined misoprostol– Foley group
of tachysystole.
who did not reach the active phase of labor (cervical
There are many proposed methods for cervical
dilation 6 cm or greater; P..05). After excluding these
ripening and induction of labor including mechanical
patients and using intention-to-treat analysis, there
(eg, transcervical Foley bulb and osmotic dilators) and
was a significant difference between groups in time
pharmacologic methods (eg, prostaglandins, oxyto-
from induction to delivery: 15.5 (11.4–22.0) hours
cin). Misoprostol is a prostaglandin E1 analog and is
vs 19.0 (14.0–27.3) hours (median [interquartile
widely used off-label for cervical ripening.11 Low-dose
range]; P5.005) in the combined and misoprostol on-
(25 micrograms) intravaginal misoprostol appears to
ly groups, respectively. However, among these 162
be safe and effective for cervical ripening in term
patients who reached the active phase, there was no
pregnancies for patients without a history of cesarean
difference between groups in median time from active
delivery and its use is endorsed by the American Col-
phase to delivery (Table 4).
lege of Obstetricians and Gynecologists.2 Compared
with other cervical ripening methods, misoprostol has
DISCUSSION an increased rate of vaginal delivery within 24 hours
The induction to delivery time in term, singleton without significant differences in cesarean delivery
pregnancies is shorter with combined misoprostol and rates or fetal outcomes.12,13
Foley bulb by approximately 4 hours in both nullip- A transcervical Foley catheter has been helpful in
arous and multiparous patients. These results held preparing the cervix for induction, possibly by release

26 Al-Ibraheemi et al Misoprostol Ripening With or Without Foley OBSTETRICS & GYNECOLOGY

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Table 2. Obstetric Characteristics

Characteristic Misoprostol Group Misoprostol+Foley Group OR (95% CI) P*

No. of misoprostol doses .01

1 or less 67 87 —
Greater than 1 33 13 —
Anesthesia .27
None 4 6 —
Neuraxial 96 91 —
General 0 3 —
Mode of delivery
Vaginal 62 70 1.4 (0.8–2.6) .23
Spontaneous 48 59 1.6 (0.9–2.7) .12
Forceps 2 1 0.5 (0.04–5.5) .57
Vacuum 12 10 0.8 (0.3–2.0) .65
Cesarean 38 30 0.7 (0.4–1.3) .23
Indication for cesarean delivery
Nonreassuring fetal tracing 20 19 1.6 (0.6–4.1) .38
Arrest of dilation 3 5 2.3 (0.5–10.7) .28
Arrest of descent 5 4 1.0 (0.2–4.2) .98
Failed induction of labor 9 2 0.2 (0.05–1.2) .08
Other 1 0 — —
OR, odds ratio.
Data are n.
* Analyzed by x2 test.

of prostaglandins. In 1967, Embrey and Mollison14
reported a 94% successful induction rate after using
the Foley catheter for cervical ripening. Since then,
several studies have found transcervical Foley cathe-
ters as effective as prostaglandin preparations for rip-
ening without an increased risk of uterine rupture.15,16
A few trials have studied the combined use of
misoprostol with a Foley bulb for cervical ripening
and induction of labor with contradicting results. A
small randomized trial by Rust et al6 from 2001
included only 81 patients and, as opposed to our
study, found that the addition of a transcervical Foley
balloon to intravaginal misoprostol did not change the
ripening to delivery time or the cesarean delivery rate.
Additionally, in that study, misoprostol was inserted
every 3 hours and was associated with a 30% rate of
tachysystole. The mean gestational age of patients was
37 and 36 5/7 weeks in the misoprostol and combined
groups, respectively, with mean birth weights of
approximately 2,800 g. In a study by Chung et al,5
146 patients were randomized to three groups and
induction by misoprostol alone was compared with
Foley alone and with a combination of misoprostol
with Foley. There were no differences in the rates of
vaginal delivery (the primary outcome) or in times
from induction to delivery, although the study was
not powered for this outcome. In that study, misopros-
tol was inserted every 3 hours and was associated with
a high rate of tachysystole (47–63%).
Conversely, Carbone et al4 studied 117 patients
who were randomized to vaginal misoprostol or com-
bined misoprostol with Foley balloon for cervical
ripening and induction of labor. Similar to our own
findings, the authors found that the mean induction to
delivery time was 3 hours shorter in the combination
group compared with vaginal misoprostol alone.

Table 3. Primary and Secondary Outcomes: Length of Labor

Outcome Misoprostol Group Misoprostol+Foley Group P

Time from induction to delivery (h)

All patients 19.0 (14.0–27.3) 15.0 (11.0–21.8) .001
Nulliparous 21.3 (14.4–27.8) 18.0 (12.4–23.3) .01
Multiparous 14.8 (10.0–19.5) 12.0 (7.0–15.5) .03
Vaginal delivery 18.0 (13.4–24.1) 14.0 (11.0–18.3) .01
Cesarean delivery 25.0 (15.0–32.0) 18.0 (11.5–23.5) .03
Per actual treatment 18.9 (13.8–26.4) 16.0 (11.0–22.0) .009
Data are median (interquartile range) unless otherwise specified.

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Table 4. Secondary Outcomes by Intention to Treat

Outcome Misoprostol Group (n5100) Misoprostol+Foley Group (n5100) P

Time from induction to active phase (h) 13.3 (6.1–20.0) 10.6 (5.1–15.0) .02
Time from active phase to delivery (h) 2.0 (0.5–3.0) 2.0 (1.0–4.0) .16
Cesarean delivery rate 38 30 .30
Tachysystole rate 12 6 .22
Estimated blood loss (mL) 400 (263–800) 375 (300–800) .93
Chorioamnionitis 8 4 .37
Data are % or median (interquartile range) unless otherwise specified.

However, different from our own study, the majority induction has the potential to decrease maternal
(66%) of participants in this trial were black. Further- complications such as chorioamnionitis and thrombo-
more, results were not analyzed by parity or by mode embolic disease, save time for the health care pro-
of delivery. A recent study by Levine et al17 evaluated viders, save hospital costs and improve resource
the effectiveness of using mechanical and pharmaco- utilization, and increase patient satisfaction.
logic methods of labor induction. This randomized The strengths of our study include the random-
trial had four arms comparing misoprostol alone, Fo- ized design, a large sample size drawn from a single
ley catheter alone, a combination of Foley catheter institution, and a diverse population. Once the
with misoprostol, and a combination of Foley catheter patients were randomized to their respective groups,
with oxytocin. Similar to our own findings, induction further decisions regarding management of labor were
with the misoprostol–Foley combination resulted in determined by the patients’ health care providers in
shortening the induction to delivery time by 4 hours accordance with hospital policies. This increases the
30 minutes compared with the misoprostol-alone generalizability of our study.
group. Again, in contrast to our own study, the study A limitation of the study is that the participants,
population in this trial was remarkably homogenous, health care providers, and investigators were not
with more than 75% black patients and more than blinded to the treatment assignment. Placing a sham
60% with public insurance. Additionally, manage- catheter in the vagina was not considered because the
ment of labor was more standardized with rupture patient’s own health care provider was the one per-
of membranes advocated when cervical dilation forming the cervical examinations and managing her
reached 4 cm and active management of labor once obstetrically. Because investigators were not involved
it reached 5 cm dilation, possibly affecting the gener- in the obstetric management of the patients, blinding
alizability of this study. of the investigators was not considered crucial for this
Our finding of shortening the length of labor by 4 study.
hours has important implications for patients, health Another limitation is that a few patients did not
care providers, and hospitals. Shortening the time of receive their allocated assignment as a result of health
care provider preference. However, the results re-
mained essentially unchanged after analysis per treat-
Table 5. Neonatal Outcomes
ment protocol. Additionally, we did not study other
Misoprostol Misoprostol prostaglandin preparations (such as prostaglandin E2
Group +Foley gel) as a result of their high cost.
Outcome (n5100) Group (n5100) P In conclusion, our study supports cervical
ripening using misoprostol in combination with
Venous cord pH 7.2660.76 7.2860.07 .2
Birth weight (g) 3,2856480 3,3146426 .66 a Foley bulb as an effective method to shorten the
5-min Apgar score 9 (9.0–9.0) 9 (9.0–9.0) .25 course of labor induction compared with misopros-
Meconium .025 tol alone. We propose using this combination as the
None 85 96 first choice when inducing a patient with an unfa-
Light 6 3
vorable cervix.
Moderate 4 1
Thick 5 0
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