Original Research ajog.

org

OBSTETRICS
Cervical ripening balloon with and without oxytocin in
multiparas: a randomized controlled trial
Alison M. Bauer, MD; Justin R. Lappen, MD; Kimberly S. Gecsi, MD; David N. Hackney, MD, MS

BACKGROUND: The optimal method for induction of labor for
multiparous women with an unfavorable cervix is unknown.
OBJECTIVE: We sought to determine if induction of labor with simul-
taneous use of oxytocin and a cervical ripening balloon, compared with
sequential use, increases the likelihood of delivery within 24 hours in
multiparous women.
STUDY DESIGN: We performed a randomized controlled trial from
November 2014 through June 2017. Eligible participants were multipa-
rous women with a vertex presenting, nonanomalous singleton gestation

34 weeks undergoing induction of labor. Women were excluded for
admission cervical examination >2 cm, ruptured membranes, cho-
rioamnionitis or evidence of systemic infection, placental abruption, low-
lying placenta, >1 prior cesarean delivery, or contraindication to vaginal
delivery. Patients were randomly allocated to the following cervical
ripening groups: simultaneous (oxytocin with cervical ripening balloon) or
sequential (oxytocin following cervical ripening balloon expulsion). The
primary outcome was delivery within 24 hours of cervical ripening balloon
placement. Secondary outcomes included induction-to-delivery interval,
time to cervical ripening balloon expulsion, mode of delivery, and adverse
maternal or neonatal outcomes.
RESULTS: In all, 180 patients were randomized (90 simultaneous, 90
sequential). Baseline demographic and obstetric characteristics were
similar between study groups. Women in the simultaneous group were
significantly more likely to deliver within 24 hours of cervical ripening
balloon placement compared to the sequential group (87.8% vs 73.3%,
P ¼ .02). The simultaneous group also had a significantly shorter
induction-to-delivery interval and greater cervical dilation at cervical
ripening balloon expulsion. There were no differences in mode of delivery,
chorioamnionitis, or adverse maternal or neonatal outcomes.
CONCLUSION: In multiparous women with an unfavorable cervix, the
simultaneous use of cervical ripening balloon and oxytocin results in an
increased frequency of delivery within 24 hours and a shorter induction-to-
delivery interval.
Key words: cervical ripening balloon, Foley balloon, induction of labor,
labor induction, multipara, oxytocin

Introduction
Induction of labor is a common proced-
ure, with >1 in 5 pregnant women in the
United States undergoing induction.1
The likelihood of vaginal delivery after
induction of labor is increased if the
cervix is favorable (Bishop score >8).2,3
Therefore, when patients present for an
induction of labor and are found to have
an unfavorable cervix, cervical ripening is
indicated. Cervical ripening balloons are
commonly used for mechanical ripening,
and have low cost and reduced risk of
uterine tachysystole compared with
prostaglandins.2 Several trials have
explored variations to the standard cer-
vical ripening balloon,4e8 including the
use of adjunctive pharmacologic induc-
tion agents, as reducing induction-to-
delivery intervals have the potential to
Cite this article as: Bauer AM, Lappen JR, Gecsi KS,
et al. Cervical ripening balloon with and without oxytocin
in multiparas: a randomized controlled trial. Am J Obstet
Gynecol 2018;219:294.e1-6.
0002-9378/$36.00
ª 2018 Elsevier Inc. All rights reserved.
https://doi.org/10.1016/j.ajog.2018.05.009
decrease health careerelated costs and
improve patient satisfaction.9e13
In 2008, a randomized controlled trial
comparing cervical ripening balloon with
and without oxytocin for cervical ripening
found that concurrent oxytocin did not
affect the primary outcome of delivery
within 24 hours.9 However, subgroup
analyses demonstrated an increased like-
lihood of delivery within 24 hours for
multiparous patients who were treated
with concurrent oxytocin.9 Randomized
controlled trials comparing simultaneous
cervical ripening balloon and oxytocin to
sequential oxytocin after cervical ripening
balloon demonstrated shortened intervals
from ripening to delivery in both nullip-
arous patients,10 and in a combined group
of nulliparous and multiparous patients.12
Conversely, a trial comparing cervical
ripening balloon alone, misoprostol
alone, cervical ripening balloon and con-
current misoprostol, or cervical ripening
balloon and concurrent oxytocin found
that concurrent cervical ripening balloon
and oxytocin did not significantly differ
from single-agent ripening methods after
adjusting for parity.11 To our knowledge,
only 1 prospective study has been
conducted to date specifically for multip-
arous patients requiring cervical ripening,
which found no difference in time to de-
livery with concurrent cervical ripening
balloon and oxytocin administration.13
Since the optimal method for induc-
tion of multiparous women is not
known, the objective of this study was to
determine if induction of labor with
simultaneous use of oxytocin and a cer-
vical ripening balloon, compared with
sequential use of oxytocin following cer-
vical ripening balloon expulsion, in-
creases the likelihood of delivery within
24 hours. We hypothesized that concur-
rent use of oxytocin and cervical ripening
balloon compared with sequential use
will increase the likelihood of delivery
within 24 hours and shorten induction-
to-delivery interval in multiparous
women undergoing induction of labor.
Materials and Methods
We performed a randomized controlled
trial at University Hospitals Cleveland
Medical Center in Cleveland, OH, from
November 2014 through June 2017. The
study was approved by the University
Hospitals Cleveland Medical Center

294.e1 American Journal of Obstetrics & Gynecology SEPTEMBER 2018

ajog.org OBSTETRICS Original Research

were able to be approached for enroll-

AJOG at a Glance ment due to study team availability on
Why was this study conducted? labor and delivery to obtain informed
To determine if induction of labor with simultaneous use of oxytocin and a consent.
cervical ripening balloon, compared with sequential use, increases the likelihood A 16F latex-free 30-mL Foley catheter
of delivery within 24 hours in multiparous women. was placed transcervically either digitally
or visually with a speculum per institu-
Key findings tional protocol, and the Foley balloon
Women who received simultaneous oxytocin with cervical ripening balloon were was inflated with 35 mL of normal saline
significantly more likely to deliver within 24 hours of cervical ripening balloon (per manufacturer package capacity).
placement and had a significantly shorter induction-to-delivery interval. The balloon was then retracted so that it
rested against the internal os, and the
What does this add to what is known? Foley was taped to the patient’s leg on
Other studies have assessed adjunctive therapies for cervical ripening balloons in tension. The Foley balloon remained in
nulliparous and mixed parity cohorts. This is the first prospective trial assessing place until it was spontaneously expelled,
cervical ripening balloon and simultaneous oxytocin in multiparous women who or was removed after 12 hours. Gentle
require cervical ripening. traction was applied hourly by the nurse
to check if the balloon was still in place.
After the Foley balloon was expelled or
Institutional Review Board for Human ruptured membranes prior to induction, removed, amniotomy was performed
Investigation (IRB#05-14-30) and was >1 prior cesarean, low-lying placenta unless the fetal head was ballotable or
registered on ClinicalTrials.gov (within 2 cm of the cervical os), or any unless delivery was thought to be
(NCT03138252) in May 2014 before contraindication to labor, vaginal imminent and adequate antibiotic pro-
enrollment. This study received no delivery, cervical ripening balloon phylaxis had not yet been administered
external funding and participants did placement, or administration of to patients who screened positive for
not receive compensation for participa- oxytocin were excluded. Participants group B streptococcus. If the patient was
tion. This study was conducted in con- who received an induction method prior randomized to the sequential group,
cert with the Consolidated Standards of to randomization were excluded. oxytocin was initiated after the cervical
Reporting Trials (CONSORT) guidelines On admission to labor and delivery, ripening balloon was removed or
and the suggested CONSORT guidelines consenting participants were random- expelled. If the patient was randomized
for obstetric research.14,15 Written ized to receive either sequential cervical to the simultaneous group, oxytocin was
informed consent was obtained from all ripening balloon followed by oxytocin initiated when the cervical ripening
trial participants before study entry. All (sequential groupecontrol) or simulta- balloon was placed. Oxytocin was
authors take responsibility for the neous cervical ripening balloon with administered per the MacDonald
completeness of the reporting and oxytocin (simultaneous groupe Women’s Hospital protocol, which stip-
adherence of the report to the study experimental). A random number ulates that oxytocin is initiated at a rate
protocol. generator (Random.org) was used to of 2 mU/min and can be increased by 2
Participants were identified and generate the randomization plan and an mU/min every 30 minutes to a
recruited either on admission to labor allocation ratio of 1:1 was utilized maximum dose of 30 mU/min. The
and delivery for induction or at prenatal without blocking of subjects into sub- oxytocin was then continued until de-
visits when being scheduled for an in- groups. The allocation for each study livery. Throughout the labor course, all
duction of labor. Patients were not participant was located in sequentially patients receiving oxytocin underwent
approached regarding enrollment until numbered, sealed opaque envelopes in a continuous uterine activity and fetal
after the plan for induction of labor had locked office on the labor and delivery heart rate monitoring.
already been made. Eligible participants unit until allocation was assigned, which The primary outcome was delivery
included women who were at least 18 occurred immediately before the study within 24 hours of cervical ripening
years of age, had a singleton non- intervention. The random allocation balloon placement. Secondary outcome
anomalous fetus at least 34 weeks’ sequence was created by the principal measures included: cervical dilation and
gestational age in vertex presentation investigator and was destroyed after the effacement after cervical ripening
with a clinical or ultrasound estimated sealed envelopes were generated. Study balloon expulsion, time to expulsion of
fetal weight of <4500 g, had a prior patients were enrolled and subsequently cervical ripening balloon, time to de-
spontaneous vaginal delivery, and had allocated by resident and attending livery (from cervical ripening balloon
cervical dilation no >2 cm on admission physicians on labor and delivery. In this placement), mode of delivery, time to
to labor and delivery. Participants with pragmatic trial, providers were not vaginal delivery, vaginal delivery within
placental abruption, chorioamnionitis, blinded to study group assignment after 24 hours; perinatal complications
systemic infection prior to induction, allocation. Not all eligible participants including postpartum hemorrhage,

SEPTEMBER 2018 American Journal of Obstetrics & Gynecology 294.e2

Original Research OBSTETRICS
FIGURE
Consolidated standards of reporting trials flow diagram
Consolidated Standards of Reporting Trials flow diagram.
CRB, cervical ripening balloon.
Bauer et al. Cervical ripening balloon and oxytocin in multiparas. Am J Obstet Gynecol 2018.
chorioamnionitis, third- or fourth-
degree perineal laceration or cervical
laceration; and neonatal outcomes
including 1- and 5-minute Apgar scores
and neonatal intensive care unit (NICU)
admission. Additional variables that
were abstracted and analyzed included
maternal age, maternal race, maternal
parity, maternal body mass index,
gestational age at delivery, and indication
for induction of labor. There were no
changes to trial outcomes or study
methods after the trial commenced.
Study data were collected and managed
using REDCap electronic data capture
tools hosted at university hospitals.16
Chorioamnionitis was diagnosed in
the presence of maternal temperature

38.0 C and at least 1 of the following:
maternal leukocytosis (>15,000 cells),
maternal tachycardia (>100 beats per
minute), fetal tachycardia (>160 beats
per minute), uterine tenderness, or foul
odor of the amniotic fluid. Postpartum
294.e3 American Journal of Obstetrics & Gynecology SEPTEMBER 2018
hemorrhage was defined as blood loss
>500 mL following vaginal delivery and
blood loss >1000 mL following cesarean
delivery. Intrauterine growth restriction
was defined as an estimated fetal weight
<10th percentile for gestational age by
ultrasound evaluation.
Using previous data, the rates of
vaginal delivery within 24 hours were
75% and 55%, respectively, for women
receiving cervical ripening balloon with
oxytocin compared with cervical ripening
balloon alone.9 Under assumption of
80% power and an alpha of 0.05, we
calculated we would need 90 patients in
each arm to demonstrate a 40% increase
(from 55e75%) in rate of primary
outcome in the treatment group.
Data were analyzed according to
intention-to-treat principle using soft-
ware (STATA, Version 13.1; StataCorp,
College Station, TX) for statistical anal-
ysis. Univariate analyses assessing cate-
gorical and continuous variables were
ajog.org
assessed using Fisher exact and 2-sample
Wilcoxon rank sum tests, where appro-
priate. A 2-tailed alpha of 0.05 was used to
determine statistical significance. No
interim analyses were planned or per-
formed. The trial was stopped after the
sample size was acquired.
Results
A total of 3153 patients underwent in-
duction of labor during the study period.
A total of 1301 of these patients were
multiparous and were assessed for eligi-
bility during the study period, and 195
patients randomized (Figure). Fifteen
patients were found not to meet study
inclusion criteria after randomization
based upon cervical dilation >2 cm on
admission to labor and delivery and were
excluded. A total of 90 patients in the
sequential group and 90 patients in the
simultaneous group were analyzed.
There were no withdrawals or patients
lost to follow-up.
ajog.org
TABLE 1
Demographic characteristics of study participants
Maternal age, y
African American race
Gravida
Prior term deliveries
Prior preterm deliveries
Gestational age at
delivery, wk
Indication for induction of labor
Elective
Postdates
Gestational or pregestational DM
Chronic or gestational
HTN, or PEC
Intrauterine growth restriction
Decreased fetal movement
Nonreassuring fetal testing
Oligohydramnios
Other maternal medical condition
Trial of labor after cesarean
Maternal BMI, kg/m2
Class-3 obesity, BMI
40 kg/m
Cervical dilation on admission, cm
Admission cervical dilation <1 cm
Cervical effacement on admission, %
Admission cervical effacement <50%
17
Simplified Bishop score
Data presented in n (%) or median (interquartile range).
Analysis was performed using Fisher exact test or 2-sample Wilcoxon rank sum test where appropriate.
BMI, body mass index; CRB, cervical ripening balloon; DM, diabetes mellitus; HTN, hypertension; PEC, preeclampsia.
Bauer et al. Cervical ripening balloon and oxytocin in multiparas. Am J Obstet Gynecol 2018.
Baseline demographic characteristics
of the study population are depicted in
Table 1. There were no significant differ-
ences in baseline demographic factors
between study groups. Primary and sec-
ondary study outcomes are listed in
Table 2. Patients who received simulta-
neous oxytocin and cervical ripening
balloon were significantly more likely to
deliver within 24 hours compared with
patients who received oxytocin following
cervical ripening balloon expulsion
(87.8% vs 73.3%, P ¼ .02; odds ratio,
OBSTETRICS Original Research
cervical ripening balloon also had signif-
icantly increased cervical dilation after
cervical ripening balloon expulsion
CRB followed by CRB with oxytocin, compared with patients in the sequential
oxytocin, sequential simultaneous group. There were no statistically signifi-
n ¼ 90 n ¼ 90 cant differences in vaginal delivery within
31 (24e35) 30 (25e33) 24 hours, cervical effacement after cervi-
77 (85.6) 76 (84.4) cal ripening balloon expulsion or time to
cervical ripening balloon expulsion.
4 (3e5) 4 (3e5)
There was no significant difference
2 (1e3) 2 (1e3) in rate of cesarean delivery, post-
0 (0e0) 0 (0e0) partum hemorrhage, chorioamnionitis,
39 (37.5e39.4) 39.1 (38e40) 1-minute Apgar score, 5-minute Apgar
score <7, or NICU admission between
study groups (Table 2). There were 3
vacuum-assisted vaginal deliveries in the
14 (15.6) 22 (24.4) sequential group. There was 1 third-
11 (12.2) 8 (8.9) degree perineal laceration in the simul-
8 (8.9) 9 (10.0) taneous group, and there were no
fourth-degree perineal or cervical lacer-
28 (31.1) 26 (28.9)
ations. In the simultaneous group, there
was 1 peripartum hysterectomy for a
5 (5.6) 8 (8.9)
previously undiagnosed placenta increta,
7 (7.8) 4 (4.4) and there was 1 unanticipated NICU
5 (5.6) 8 (8.9) admission for a patient who required
2 (2.2) 3 (3.3) general anesthesia for cesarean. These
were adverse events reported to the
10 (11.1) 2 (2.2)
institutional review board, but were not
6 (6.67) 10 (11.11) found to be study related.
36.5 (30e41) 36 (31e40)
2
30 (33.3) 26 (28.9) Comment
In this randomized controlled trial of
1 (1e1.5) 1 (1e1.5) multiparous women requiring cervical
15 (16.7) 18 (20) ripening, we demonstrated that the
50 (30e50) 50 (30e50) simultaneous use of a cervical ripening
balloon with oxytocin results in a greater
34 (37.8) 27 (30)
frequency of delivery within 24 hours
2 (1e2) 2 (1e2) and a shorter induction-to-delivery in-
terval than sequential use of cervical
ripening balloon followed by oxytocin.
Between study groups, there was no
difference in any maternal or neonatal
morbidity. The simultaneous use of
2.61; 95% confidence interval, cervical ripening balloon with adjunctive
1.19e5.73). Patients who received pharmacologic agents should be incor-
simultaneous oxytocin and cervical porated into the management for
ripening balloon also had a significantly multiparous women with an unfavorable
shorter induction-to-delivery interval cervix undergoing labor induction.
compared with patients who received The optimal method of cervical
oxytocin following cervical ripening ripening and induction of labor for
balloon expulsion, and a significantly multiparous women is unknown, as
shorter induction-to-vaginal delivery in- prior publications have assessed cervical
terval compared with patients who ripening balloon and adjunctive agents
received oxytocin following cervical in nulliparous populations or cohorts of
ripening balloon expulsion. Patients who mixed parity. Previous trials assessing
received simultaneous oxytocin and adjunctive agents to cervical ripening
SEPTEMBER 2018 American Journal of Obstetrics & Gynecology 294.e4
Original Research OBSTETRICS ajog.org

TABLE 2
Primary and secondary outcomes
CRB followed by oxytocin, CRB with oxytocin,
sequential simultaneous
n ¼ 90 n ¼ 90 P
Delivery within 24 h of CRB placement 66 (73.3) 79 (87.8) .023
Time to delivery from CRB placement, h 16.88 (12.7e24.4) 13.13 (10.8e17.7) .004
Vaginal delivery within 24 h of CRB placement 54 (60.0) 69 (76.7) .07
Time to vaginal delivery from CRB placement, h 16.3 (12.1e21.5) 12.5 (10.6e17.5) .01
Time to CRB expulsion, h 3.25 (1.5e4.6) 2.59 (1.3e4) .32
CRB removed after 12 h 3 (1.7) 2 (1.1) 1.00
Cervical dilation after CRB expulsion, cm 3.5 (3e4) 4 (3.5e4.5) .001
Cervical effacement after CRB expulsion, % 50 (50e60) 50 (50e60) .05
Duration of oxytocin administration, h 12.83 (8.3e17.6) 12.65 (10.7e17.6) .47
Maximum dose of oxytocin administered, mU/h 14 (10e20) 14 (9e16) .27
Total cesarean deliveries 21 (23.3) 13 (14.4) .18
Cesarean delivery for nonreassuring 13 (14.4) 5 (5.6) .08
fetal heart tracing
Postpartum hemorrhage 8 (8.9) 6 (6.7) .78
Chorioamnionitis 5 (5.6) 5 (5.6) 1.00
1-min Apgar score 8 (8e9) 8 (8e9) .45
5-min Apgar score <7 2 (2.2) 3 (3.3) 1.00
Neonatal intensive care unit admission 6 (6.7) 11 (12.2) .31
Data presented in n (%) or median (interquartile range).
Analysis was performed using Fisher exact test or 2-sample Wilcoxon rank sum test where appropriate.
CRB, cervical ripening balloon.
Bauer et al. Cervical ripening balloon and oxytocin in multiparas. Am J Obstet Gynecol 2018.

balloon have demonstrated conflicting
results. Three randomized controlled
trials demonstrated no significant dif-
ference in delivery within 24 hours or
induction-to-delivery time in patients
who received simultaneous oxytocin and
cervical ripening balloon compared with
sequential use.9,11,13 Pettker and col-
leagues9 randomized 183 women of
mixed parity to sequential or simulta-
neous cervical ripening balloon and
oxytocin and found no significant dif-
ference in time to delivery or likelihood
of delivery within 24 hours, though in a
subgroup analysis of multiparous pa-
tients, found significantly more women
who received simultaneous oxytocin and
cervical ripening balloon delivered
within 24 hours. Levine and colleagues11
randomized 491 women of mixed parity
to induction with misoprostol alone,
cervical ripening balloon and oxytocin,
cervical ripening balloon and miso-
prostol, or cervical ripening balloon
alone. They found that both nulliparous
and multiparous women who received
a cervical ripening balloon and miso-
prostol or oxytocin had a significantly
shorter time to delivery and were
significantly more likely to deliver within
24 hours compared with misoprostol or
cervical ripening balloon alone. Though
when their data were censored for ce-
sarean delivery and adjusted for parity,
the combination method of cervical
ripening balloon and oxytocin was no
longer statistically significantly different
from single-agent induction methods.11
Connolly and colleagues13 randomized
142 multiparous women to receive either
sequential or simultaneous cervical
ripening balloon and oxytocin and
found that there was no difference in
time to delivery between groups.
However, 2 other randomized
controlled trials did demonstrate a sig-
nificant increase in delivery within 24
hours and significantly shorter
induction-to-delivery interval in patients
who received simultaneous oxytocin and
cervical ripening balloon.10,12 Schoen and
colleagues12 randomized 323 women of
mixed parity to receive either sequential
or simultaneous oxytocin and cervical
ripening balloon, and found that
multiparous women who received
simultaneous oxytocin and cervical
ripening balloon were more likely to
deliver within 24 hours and the time to
delivery was significantly shorter. Con-
nolly and colleagues10 randomized 166
nulliparous women to receive either
sequential or simultaneous cervical
ripening balloon and oxytocin and found
that simultaneous administration resul-
ted in a significantly shorter time to

294.e5 American Journal of Obstetrics & Gynecology SEPTEMBER 2018

ajog.org
delivery among nulliparous patients.
Given the varying results in the existing
medical literature, the optimal method
for induction of labor in multiparous
women is still unknown, and our trial
adds to the existing medical literature.
Strengths of this study include that it
was a prospective, randomized
controlled trial. Strengths also include
that we were able to obtain complete
data, without loss to follow-up, and we
used an objective, reproducible measure
as our primary outcome. Additionally,
our institution has consistent guidelines,
so management of labor, use of cervical
ripening balloon, and oxytocin were
standardized, minimizing the potential
for variation between providers. Limi-
tations of our trial deserve mention. As a
pragmatic trial, it was not feasible to
mask providers to the intervention
group. Cervical ripening was proto-
colized for both groups, and given labor
management guidelines minimizing
intraprovider variation, the potential for
type of cervical ripening to bias labor
management or induction-to-delivery
interval is minimized, though cannot
be excluded. Although there has been
evidence to support using a Foley
balloon inflated with greater volume,
our hospital prohibits the use of latex
products, and the balloons at our insti-
tution are smaller with a 35-mL capacity.
The same balloons were used in both
groups, but this may limit comparison of
results to other trials and generalizability
of particular factors, such as the degree
of cervical dilation after balloon expul-
sion. The inability to recruit all eligible
patients is a potential source of selection
bias, though since we were able to recruit
72% of all eligible participants, this does
not likely alter the generalizability of our
results. Finally, this study was not pow-
ered to assess adverse maternal and
neonatal outcomes, which are rare,
though no differences were observed.
While our primary outcome had sig-
nificant results, another potential limi-
tation of our study is that we used
delivery within 24 hours as our primary
outcome, as we assumed the vast ma-
jority of multiparous patients would
have a vaginal delivery. Using total de-
liveries within 24 hours has the
OBSTETRICS
advantage that at onset of labor it is un-
known who will have a vaginal delivery
and who will not, though this introduces
potential bias to our findings due to
censorship of intrapartum cesarean de-
liveries. Though vaginal delivery within
24 hours was not formally statistically
significant (P ¼ .07), time from
induction-to-vaginal delivery was statis-
tically significant (P ¼ .01).
Concurrent administration of
oxytocin while undergoing cervical
ripening with a cervical ripening balloon
is plausible given that cervical ripening
balloon works mechanically, though
there is release of prostaglandins, while
oxytocin stimulates contractions phar-
macologically. Though the magnitude of
change may be small, the clinical impli-
cations of a shorter induction-to-
delivery interval are significant.
In summary, simultaneous adminis-
tration of oxytocin and cervical ripening
balloon for cervical ripening in multip-
arous patients results in a greater fre-
quency of delivery within 24 hours and a
shorter induction-to-delivery interval
without increasing maternal or neonatal
morbidity. The simultaneous use of
oxytocin with cervical ripening balloon
should be incorporated into the man-
agement for multiparous women who
require cervical ripening while under-
going induction of labor. n obstetric research. Obstet Gynecol 2013;122:
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Author and article information
From the Division of Maternal-Fetal Medicine (Drs Bauer,
Lappen, and Hackney), Department of Obstetrics
and Gynecology (all authors), University Hospitals,
Cleveland, OH.
Received Jan. 24, 2018; revised April 19, 2018;
accepted May 7, 2018.
The authors report no conflict of interest.
Presented as a poster at the 38th Annual Pregnancy
Meeting of the Society for Maternal-Fetal Medicine,
Dallas, TX, Jan. 29eFeb. 3, 2018.
Corresponding author: Alison M. Bauer, MD. Alison.
Bauer@UHhospitals.org
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