Original Research
Foley Plus Oxytocin Compared With
Oxytocin for Induction After
Membrane Rupture
A Randomized Controlled Trial
A. Dhanya Mackeen, MD, MPH, Danielle E. Durie, MD, Monique Lin, MD, Christopher K. Huls,
Emma Qureshey, MD, Michael J. Paglia, MD, PhD, Haiyan Sun, MS, and Anthony Sciscione, DO
OBJECTIVE: To evaluate the use of a transcervical Foley
catheter plus oxytocin infusion compared with oxytocin
infusion alone for labor induction and cervical ripening in
women 34 weeks of gestation or greater with prelabor
rupture of membranes.
METHODS: This is a randomized, multicenter trial of
women with a live, singleton gestation at 34 weeks of
gestation or greater with prelabor rupture of membranes,
an unfavorable cervical examination (less than 2 cm or 80%
effaced), and no contraindication to labor. Participants were
randomly allocated to a transcervical Foley catheter inflated
to 30 cc with concurrent oxytocin infusion or oxytocin
From the Department of Obstetrics and Gynecology, Division of Maternal-Fetal
Medicine and Biostatistics Core, Geisinger, Danville, Pennsylvania; the
Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine,
Lehigh Valley Health Network, Allentown, Pennsylvania; the University of
Colorado School of Medicine, Aurora, Colorado; the University of Arizona
College of Medicine, Phoenix at Banner University Medical Center, Phoenix,
Arizona; and Christiana Care Health System, Newark, Delaware.
Both Geisinger and Lehigh Valley Health Network received small internal grants
to assist with the conduct of the study at those individual sites. The internal grant
at Geisinger was also applied for the statistical analyses for the entire study.
Presented at the 37th Annual Meeting of the Society for Maternal-Fetal Medicine,
January 23–28, 2017, Las Vegas, Nevada.
The authors thank Natacha Antunes, Kristina Blessing, Ana Bodea Braescu, Dr
Kendra Gray, Vicki Greenberg, Carrie Kitto, Dr Sandra Madueke-Laveaux,
Gloria Mullen, Dr Roger Packard, Dr Trevor Quinor, Rachel Rodel, Duane
Shaffer, Mallory Snyder, and Mary Sobotor for assisting with the conduct of
the study at the individual study sites; and the resident, research, and labor
and delivery staff at all participating institutions.
Each author has indicated that he or she has met the journal’s requirements for
authorship.
Corresponding author: A. Dhanya Mackeen, MD, MPH, 100 N Academy
Avenue, Danville, PA 17822; email: admackeen@geisinger.edu.
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 Ó by The American College of Obstetricians
and Gynecologists. Published by Wolters Kluwer Health, Inc.
Unauthorized reproduction of this article is prohibited.
MD,
infusion alone. Oxytocin administration was standardized
across sites. The primary study outcome was interval from
induction to delivery. To detect a 2.5-hour difference in the
interval from induction to delivery, we required outcome
data on 194 women, assuming 80% power and a two-tailed
a of 5%. Analysis was by intent to treat.
RESULTS: We enrolled 201 women: 93 were allocated
to Foley and 108 to oxytocin. Demographics were
similar between the groups. Time to delivery was not
significantly different between groups: in the Foley
group, it was 13.9 hours (66.9 SD) compared with
14.4 hours (67.9 SD) in the oxytocin group (P5.69).
There were more cases of clinical chorioamnionitis
(8% compared with 0%, P,.01) in the Foley group com-
pared with the oxytocin group. There were no differ-
ences for other infectious morbidities or any other
variable studied.
CONCLUSION: In patients with prelabor rupture of
membranes, the use of a transcervical Foley catheter in
addition to oxytocin does not shorten the time to
delivery compared with oxytocin alone, but may increase
the incidence of intraamniotic infection.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov,
NCT01973036.
(Obstet Gynecol 2018;131:1–8)
DOI: 10.1097/AOG.0000000000002374
P
relabor rupture of membranes (PROM) compli-
cates between 3% and 19% of all pregnancies
and 8–10% of pregnancies at term.1 Of those with
term PROM, approximately 40% will not spontane-
ously enter labor by 24 hours.2 Multiple studies have
demonstrated that prolongation of latency greater
than 24 hours is associated with increased incidence
of chorioamnionitis and neonatal sepsis.1–3 Results
from the largest randomized trial to date of expectant
OBSTETRICS & GYNECOLOGY 1
management compared with labor induction in
women with term PROM demonstrated that expectant
management was associated with a significantly
increased incidence of clinical chorioamnionitis, post-
partum fever, and longer neonatal length of stay (LOS)
in the neonatal intensive care unit compared with
induction of labor with oxytocin.2 Expedient delivery
appears to be the optimal management strategy for
women with term PROM.
In the setting of PROM, oxytocin and prostaglan-
dins have similar efficacy4 and a transcervical Foley
catheter may result in a shorter time to delivery with-
out increased risk of infectious morbidity compared
with misoprostol.5,6 However, evidence comparing
a Foley catheter with oxytocin in PROM is limited.
Two smaller studies examined the efficacy of a Foley
catheter (with or without concurrent oxytocin) in the
setting of PROM and found no difference in time to
delivery or infectious morbidity compared with
oxytocin.7,8 A concern with mechanical cervical
ripening in the setting of PROM is increased risk of
intraamniotic infection and other infection morbidity,
which is not increased when membranes are intact.9
Although the Foley catheter has been established as
safe and effective in women with intact membranes,
its efficacy has not been established in women with
PROM.
Oxytocin is not the method of choice for cervical
ripening in women with intact membranes and an
unfavorable cervix, so we hypothesized that it is
unlikely to be the optimal choice in women with
ruptured membranes and an unfavorable cervix. The
objective of this study was to assess whether cervical
ripening with a Foley catheter plus oxytocin decreases
the interval to delivery and associated complications
compared with oxytocin alone in women at 34 weeks
of gestation or greater with PROM.
MATERIALS AND METHODS
This trial was conducted as a multicenter, randomized
controlled investigation in accordance with the
published Consolidated Standards of Reporting Trials
guidelines10 with full institutional review board
approval at four institutions: Geisinger (Danville and
Wilkes-Barre, Pennsylvania), Lehigh Valley Health
Network (Allentown, Pennsylvania), Banner University
Medical Center (Phoenix, Arizona), and Christiana
Care Health System (Newark, Delaware). Women with
a live, singleton gestation at 34 weeks of gestation or
greater with PROM, an unfavorable cervical examina-
tion (less than 2 cm or 80% effaced), and no contrain-
dication to labor were approached for study
participation. Obstetric care providers on labor and
2 Mackeen et al Foley Plus Oxytocin vs Oxytocin Alone in PROM
Copyright Ó by The American College of Obstetricians
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Unauthorized reproduction of this article is prohibited.
delivery performed cervical examinations and assess-
ments for PROM. Women who experienced PROM
before 34 weeks of gestation were eligible for this
study if they did not meet any exclusion criteria once
they were eligible for labor induction at 34 weeks of
gestation. Women had to spontaneously rupture mem-
branes at least 60 minutes before starting induction.
Spontaneous rupture of membranes was defined as
a clinical history with the presence of at least two of
the following four criteria: pooling, ferning, Nitrazine,
or oligohydramnios. In the absence of a clinical his-
tory, ultrasonographically diagnosed oligohydramnios
and pooling were necessary for the diagnosis of rup-
ture of membranes. Oligohydramnios was defined as
a total amniotic fluid index less than 5 cm or a maxi-
mum vertical pocket less than 2 cm. Additionally, the
fetus had to be cephalic and the mother English-
speaking with a plan for vaginal delivery. Maternal
exclusion criteria included those in active labor and
those with suspected intraamniotic infection, abrup-
tion or significant hemorrhage, latex allergy, greater
than one prior cesarean delivery, any contraindication
to vaginal delivery, or human immunodeficiency virus
or acquired immunodeficiency syndrome. Active
labor was defined as contractions more frequent than
every 5 minutes (or 12 contractions or greater in 1
hour) associated with 1 cm or greater cervical change.
In the absence of 1 cm or greater cervical change after
2 hours, patients with contractions could be included
in the study. Fetal exclusion criteria were multifetal
gestations, lethal fetal anomalies, intrauterine fetal
demise, and category II or III fetal heart rate tracings.
Women who met the previously mentioned
requirements were invited to participate; those who
gave written informed consent were enrolled and
randomized. Randomization was based on a one-to-
one computer-generated schema in random-sized blocks
stratified by multiparity or primiparity, preterm or term
gestation, and hospital site. The randomization schema
was created by Geisinger and maintained through
a Microsoft Access database at each individual site.
Participants were randomly allocated to oxytocin
infusion alone or to a Foley catheter with concurrent
oxytocin infusion. Allocation was not concealed. All
women received an intravenous oxytocin infusion that
was standardized across sites. Oxytocin was started at
a dose of 2 milliunits/min and increased by 2 milli-
units/min every 30 minutes to achieve an adequate
contraction pattern, as per the institution’s definition,
to a maximum dose of 30 milliunits/min. For women
randomized to Foley, a 16-French latex Foley catheter
with a 30-cc balloon was introduced past the internal
cervical os into the lower uterine segment using
OBSTETRICS & GYNECOLOGY
a sterile speculum and ring forceps or sterile vaginal
examination with or without a sterile Foley guidewire.
The balloon was inflated with 30 cc sterile water or
saline, pulled back until taut, and the Foley was taped
to the inside of the maternal thigh under tension. If the
initial attempt at Foley placement was not successful,
the obstetric care provider could attempt to reintro-
duce the catheter within 1 hour of the first attempt.
If the second attempt remained unsuccessful, oxytocin
infusion was continued. Catheter checks were per-
formed hourly by traction. If the Foley had not been
expelled within 12 hours, it was deflated and removed.
Timing of anesthesia administration, use of fetal
scalp electrodes, and intrauterine pressure catheters
were at the discretion of the treating team. Antibiotics
were administered as per evidence-based indications
for group B streptococci prophylaxis or clinically
suspected intraamniotic infection.11 Cesarean delivery
was performed at the managing team’s discretion for
maternal or fetal indications. If the patient was not in
labor after 24 hours, the management was per the
discretion of the attending physician.
Outcomes data were either documented in an
ongoing fashion by the labor and delivery team or
abstracted from the medical records by research per-
sonnel not involved with data analysis. Data were
abstracted by the individual sites and recorded on the
study case report form, which was sent to the primary
site for centralized data entry. Data entry was double-
checked. The primary outcome was the interval from
induction to delivery. The start of the induction was
either the time the Foley catheter was inserted or the
time the oxytocin was started, whichever occurred first.
Linear regression was used to adjust for body mass index
{BMI, calculated as weight (kg)/(height [m])2}, delivery
mode, and stratification variables. Secondary outcomes
included interval from induction to vaginal delivery,
interval from induction to delivery excluding those with
PROM before 34 weeks of gestation, cesarean delivery
rate, rate of vaginal delivery within 12 and 24 hours,
indication for cesarean delivery, infection complications
(eg, clinically suspected chorioamnionitis, endometritis,
and maternal sepsis), maternal LOS (from admission to
discharge and delivery to discharge), and neonatal out-
comes (eg, 5-minute Apgar score less than 5, neonatal
infectious evaluation and diagnosis of sepsis, LOS, neo-
natal intensive care unit admission, and neonatal inten-
sive care unit LOS). Chorioamnionitis was defined as
temperature 38°C (or 100.4°F) or greater with at least
two of the following: uterine tenderness, maternal tachy-
cardia (heart rate 100 beats per minute or greater), fetal
tachycardia (heart rate 160 beats per minute or greater),
foul odor of the amniotic fluid, or maternal leukocytosis
VOL. 131, NO. 1, JANUARY 2018 Mackeen et al
Copyright Ó by The American College of Obstetricians
and Gynecologists. Published by Wolters Kluwer Health, Inc.
Unauthorized reproduction of this article is prohibited.
(greater than 15,000 cells/mL3).12 To ensure that our
results would be more generalizable, we also planned
to analyze our data using a less stringent definition of
chorioamnionitis, that is, maternal temperature plus one
of the aforementioned criteria. Because preterm PROM
is associated with increased risk of intraamniotic
infection, we planned to exclude all those who were
hospitalized with preterm PROM before 34 0/7 weeks
of gestation from the analysis of chorioamnionitis. At the
conclusion of our study, a new definition for suspected
intraamniotic infection arose, so we assessed our data
with regard to this definition as well. Suspected intra-
amniotic infection was defined as temperature 39°C or
greater (or temperature 38°C or greater sustained for
30 minutes) with one additional finding: fetal tachycar-
dia, purulent cervical drainage, or maternal leukocyto-
sis.13 Endomyometritis was defined as temperature 38°C
or greater plus one of the following: fundal tenderness,
maternal tachycardia, purulent cervical discharge, and
no other source of fever.
Planned sample size for this investigation was based
on detecting a clinically significant difference in the
induction-to-delivery interval. Data from several pub-
lished sources comparing the use of oxytocin in this
clinical setting were used for the sample size estimation.
A mean of 11.666.2 hours for the oxytocin group was
assumed.14–17 We were required to collect outcome
data on 194 women, assuming 80% power and 5% sig-
nificance to detect a 2.5-hour difference in the induction
to delivery time between the groups using a two-sided
two-sample equal-variance t test. The sample size calcu-
lation further assumed one interim analysis (for the data
safety monitoring board) using the O’Brien-Fleming
spending function. The significance level was set at
.003 and .049 at the first and final analyses, respectively.
Analysis was by intention to treat. An as-treated analysis
was also performed. Proportional data were compared
with the x2 or Fisher exact test as appropriate. Contin-
uous data were compared with either the Student t test
or the Wilcoxon rank-sum test if data were not nor-
mally distributed. All data are expressed as means
and SDs unless otherwise noted. Analysis of covariance
was used to assess differences between treatment
modality groups adjusted for important covariates
(stratification factors, BMI, and cesarean delivery).
Kaplan-Meier curve analysis was performed to assess
the time to delivery censored for cesarean delivery.
Statistical significance was defined as two-sided P,.05.
Statistical analyses were performed with SAS 9.4.
RESULTS
From March 2014 to July 2016, we randomized 201
women, 93 to Foley (88 received Foley) and 108 to
Foley Plus Oxytocin vs Oxytocin Alone in PROM 3
 Fig 1. Flow diagram.
Mackeen. Foley Plus Oxytocin vs
Oxytocin Alone in PROM. Obstet
Gynecol 2018.

oxytocin (113 received oxytocin alone; Fig. 1).
Demographic and antenatal characteristics were simi-
lar between groups (Table 1). There were 46 partic-
ipants enrolled at Geisinger, 84 at Lehigh Valley
Health Network, 49 at Banner University Medical
Center, and 22 at Christiana Care Health System.
The most common reason for Foley catheter removal
was spontaneous expulsion (84%).
Approximately 44% of women in both groups
received antibiotics during labor: group B streptococci
prophylaxis was the most common indication (Foley
64% compared with oxytocin 73%, P5.35). The use of
epidural anesthesia was also similar between the two
groups (Foley 88% compared with oxytocin 95%,
P5.06). Ten patients experienced PROM before 34
weeks of gestation.

Table 1. Demographic and Antenatal Characteristics

Characteristic Foley Group (n593) Oxytocin Group (n5108)

Age (y) 27.5 (23.4–32.2) 27 (22.8–31.4)

Race: non-Hispanic white 56 (60) 61 (56)
Education
High school or less 24 (26) 39 (36)
Some college 18 (19) 22 (20)
College graduate 22 (24) 22 (20)
Unknown 29 (31) 25 (23)
Insurance
Public 37 (40) 43 (40)
Private 52 (56) 62 (57)
Both 2 (2) 2 (2)
Marital status: single 49 (53) 58 (54)
Parity: nulliparous 56 (60) 70 (65)
Admission BMI (kg/m2) 32.8 (28.3–37.6) 30.9 (27.3–35.6)
Admission indication
PROM at less than 34 0/7 wk of gestation 6 (6) 4 (4)
PROM at 34 0/7 wk of gestation or greater 87 (94) 104 (96)
Preterm (GA less than 37 wk) 21 (23) 22 (20)
GBS status: negative 63 (68) 79 (73)
Prior cesarean delivery 7 (7) 5 (5)
Latency antibiotics 14 (15) 12 (11)
Antenatal corticosteroids 7 (7) 6 (6)
BMI, body mass index; PROM, prelabor rupture of membranes; GA, gestational age; GBS, group B streptococci.
Data are median (interquartile range) or n (%).

4 Mackeen et al Foley Plus Oxytocin vs Oxytocin Alone in PROM OBSTETRICS & GYNECOLOGY

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Table 2. Induction-to-Delivery Interval (Unadjusted)

Foley Group Oxytocin Group

Type of Delivery (n593) (n5108) P

All deliveries (h) 13.966.9 14.467.9 .69

Vaginal deliveries (h) 12.265.3 12.666.4 .63
All deliveries excluding those with preterm PROM before 34 wk of gestation (h) 14.267.0 14.468.0 .81
PROM, prelabor rupture of membranes.
Data are mean6SD unless otherwise specified.

Although the average induction time was shorter
in the Foley group as compared with the oxytocin
group (Table 2), this difference of approximately 0.4
hours is neither clinically nor statistically significant.
As planned, we performed an adjusted linear regres-
sion analysis and there remained a nonsignificant
shorter time to delivery of 0.9 hours (95% CI 22.8
to 1.0; P5.35) in those who were treated with Foley
as compared with oxytocin when adjusting for
preterm, parity, hospital site, BMI, and cesarean
delivery. An as-treated analysis was performed and
revealed a mean time to delivery of 6.9 hours (SD
12.7) for the 88 patients treated with Foley and 7.9
hours (SD 12.6) for the 113 patients treated with
oxytocin (P5.59). The overall proportion of women
delivered within 12 and 24 hours was similar
between the Foley and oxytocin groups (Table 3).
No significant differences were noted between study
groups with respect to mode of delivery or indica-
tions for cesarean delivery (Table 3). The mean time
to delivery did not differ significantly between
treatment groups when assessing only multiparous
women (11.6 hours [65.7 SD] Foley compared with
11.9 hours [66.1 SD] oxytocin, P5.87); the same was
true for nulliparous women (15.5 hours [67.3 SD]
Foley compared with 15.7 hours [68.4 SD] oxytocin,
P5.88). In a Kaplan-Meier analysis, no significant
differences were noted between women receiving
Foley compared with oxytocin with respect to time
to delivery (Fig. 2).

Table 3. Delivery, Maternal, and Neonatal Outcomes

Outcome Foley Group (n593) Oxytocin Group (n5108) P

Delivery outcomes
Vaginal delivery within 12 h 34 (37) 46 (43) .38
Vaginal delivery within 24 h 61 (66) 80 (74) .19
Cesarean delivery 25 (27) 21 (19) .35
Indication for cesarean delivery
Elective 3 (12) 3 (15) 1.0
Category II or III fetal heart rate tracing 11 (44) 6 (30) .34
Active phase arrest 9 (36) 8 (40) .78
2nd-stage arrest 8 (32) 10 (48) .28
Maternal outcomes
Chorioamnionitis 7 (8) 0 ,.01
Endometritis 0 0 —
Culture-proven maternal sepsis 0 0 —
Maternal treatment with postpartum antibiotics 10 (11) 5 (5) .10
Maternal LOS from admission to discharge (d) 3 (2–4) (n591) 3 (2–3) (n5108) .17
Maternal LOS from delivery to discharge (h) 47.8 (41.2–58.7) (n592) 48.1 (38.8–57.2) (n5107) .34
Neonatal outcomes
5-min Apgar score less than 5 1 (1) 1 (1) 1.0
Neonatal infectious evaluation 33 (35) 25 (23) .05
Culture-proven neonatal sepsis 0 0 —
Time from delivery to discharge (h), mean (SD) 52.4620.0 49.7616.9 .30
NICU admission 21 (23) 20 (19) .48
NICU LOS (d) 5.0 (1.0–6.0) (n521) 5.5 (3.5–7.5) (n520) .21
NICU LOS from admission to hospital discharge (d) 5.0 (2.0–7.0) (n521) 5.5 (3.5–7.5) (n520) .37
LOS, length of stay; NICU, neonatal intensive care unit.
Data are n (%) or median (interquartile range) unless otherwise specified.

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 excluding those with PROM before 34 weeks of gesta-
tion, none of those 10 patients had chorioamnionitis, so
we kept them in the analysis.

Fig 2. Kaplan-Meier plot of overall time to delivery in
hours. Plus sign indicates censoring for cesarean delivery.
Mackeen. Foley Plus Oxytocin vs Oxytocin Alone in PROM.
Obstet Gynecol 2018.
Except for chorioamnionitis, there were no differ-
ences for other delivery outcomes, other infection
morbidities, or any other outcome studied, including
endometritis and neonatal sepsis (Table 3). The rate of
intrauterine pressure catheter placement (36% Foley
compared with 32% oxytocin, P5.54) and vaginal
examinations (6.8 Foley compared with 6.2 oxytocin,
P5.06) did not differ between groups. Although there
was a significantly higher rate of fetal scalp electrode
use in the Foley group (28% compared with 13%
oxytocin, P,.01), logistic regression analysis showed
that fetal scalp electrode use was not related to
chorioamnionitis, regardless of definition used
(P5.37). As planned, we applied several definitions of
chorioamnionitis and intraamniotic infection; regard-
less of the definition used, there were significantly more
cases of infection in those who were treated with Foley
as compared with those who were treated with
oxytocin (Table 4). Those with suspected intraamniotic
infection had an induction-to-delivery interval that was
9 hours longer than those without suspected infection.
Although we initially planned to analyze these data
DISCUSSION
In patients with PROM, the use of a transcervical
Foley catheter in addition to oxytocin does not
shorten the time to delivery compared with oxytocin
alone, but may increase the incidence of intraamniotic
infection.
A few studies have evaluated the efficacy and
safety of the Foley catheter in the setting of PROM
with mixed results: one noted a significantly shorter
time to delivery with the Foley catheter compared
with misoprostol6; the randomized controlled trial
found similar induction to delivery times and rates
of infection morbidity.5
A retrospective study comparing a Foley catheter
(with or without oxytocin) with oxytocin alone showed
no difference in infection morbidity between groups.18
A recent randomized trial comparing Foley plus
oxytocin and oxytocin only in the setting of PROM
in nulliparous women also found a nonsignificant
difference in time to delivery without any statistically
significant difference in chorioamnionitis. This smaller
study differed from ours in several ways. They did not
mandate cervical examination before randomization
(and the cervix was not examined in 17 patients who
were randomized and analyzed); the Foley catheter
was inflated to 60 cc, and their oxytocin protocol
differed from ours. Likely the 128 patients included
in their study were not sufficient to find a statistically
significant difference in chorioamnionitis, although
twice as many patients in the Foley plus oxytocin
group had chorioamnionitis compared with the
oxytocin alone group (10% compared with 5%,
P5.31). Lastly, they did not define their diagnosis of
chorioamnionitis.8

Table 4. Clinical Diagnosis of Infection Based on the Specific Definition Used

Overall Rate of Foley Oxytocin

Definition n Chorioamnionitis (n593) (n5108) P

Chorioamnionitis based on maternal temperature 38˚C or greater and two 201 7 (3) 7 (8) 0 ,.01
of the following: maternal tachycardia, fetal tachycardia, purulent
discharge, amniotic fluid with foul odor, maternal leukocytosis
Chorioamnionitis based on maternal temperature 38˚C or greater and one 201 11 (5) 9 (10) 2 (2) .03
of the following: maternal or fetal tachycardia, purulent discharge,
amniotic fluid with foul odor, maternal leukocytosis
Suspected intraamniotic infection defined as temperature 39˚C or greater 201 8 (4) 7 (8) 1 (1) .03
or sustained temperature 38˚C or greater with one additional finding:
fetal tachycardia, purulent cervical drainage, or maternal leukocytosis
Data are n (%) unless otherwise specified.

6 Mackeen et al Foley Plus Oxytocin vs Oxytocin Alone in PROM OBSTETRICS & GYNECOLOGY

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 Strengths of our study were several. This was
a multicenter randomized controlled trial with a diverse
patient population. We applied a computerized random-
ization database stratified by hospital site, parity, and
preterm status. All patients had an initial cervical
examination before consideration for inclusion in the
study. All four sites applied the same oxytocin protocol.
Data entry was double-checked for accuracy. The
chorioamnionitis definition was standardized and based
on objective data. Charts of all identified cases of
chorioamnionitis were reconfirmed by the site principal
investigator.
This study also had some limitations. We
calculated that 194 women were required to detect
a difference in delivery time of 2.5 hours between
the two groups. However, the difference in deliv-
ery interval in our group was only 0.4 hours,
neither statistically nor clinically significant. Some
debate about the appropriate primary outcome for
labor induction and cervical ripening studies. We
opted to assess the time from induction to delivery
(without excluding cesarean delivery) because we
felt time to delivery (regardless of mode) was the
most applicable outcome in clinical practice. There
were no significant differences in the incidence of
cesarean delivery between the groups. We also
assessed time to vaginal delivery and vaginal
delivery within 12 and within 24 hours.
Given our initial assumptions for power calcula-
tion, this study has 70% power to detect a difference
of 2.5 hours for the 155 patients who delivered
vaginally.
We were not able to assess whether any partic-
ular aspect of Foley catheter use increases the risk of
chorioamnionitis, for example, method of insertion,
length of time with the Foley in place, or whether
there is a technique that could be applied to decrease
the risk of infection, for example, cervical preparation
with Betadine before catheter insertion. Although we
had hoped to assess histopathologic examination as
a secondary outcome, we did not dictate that placen-
tal pathology be sent in all participants because this
was not the primary aim of the study. Only one third
of the placentas in our study were sent for pathologic
evaluation.
The fact that clinical intraamniotic infection
differed between treatment groups should make us
question whether use of a Foley catheter is appropri-
ate in those with ruptured membranes. A post hoc
power analysis was done showing that we had 81%
power to show a difference in chorioamnionitis based
on the strict definition we used (ie, maternal fever
plus two criteria).
VOL. 131, NO. 1, JANUARY 2018 Mackeen et al
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and Gynecologists. Published by Wolters Kluwer Health, Inc.
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In conclusion, transcervical Foley plus oxytocin
infusion does not significantly shorten the interval to
delivery as compared with oxytocin infusion alone
for labor induction in women at 34 weeks of
gestation or greater with PROM. Additionally,
the Foley catheter may increase the risk of
chorioamnionitis.
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8 Mackeen et al Foley Plus Oxytocin vs Oxytocin Alone in PROM OBSTETRICS & GYNECOLOGY

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