Journal of Gynecology Obstetrics and Human Reproduction 49 (2020) 101745

Available online at

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www.sciencedirect.com

Can we induce labor by mechanical methods following preterm

premature rupture of membranes?
Alexane Tourniera,* , Elodie Clouqueura , Elodie Drumezb , Céline Petita , Marion Guckerta ,
Véronique Houfflin-Debargea,c , Damien Subtila , Charles Garabediana,c
a
CHRU Lille, Clinique d’Obstétrique, F-59000, Lille,France
b
CHRU Lille, Département debiostatistiques, Univ. Lille, EA 2694 - Santé Publique: Épidémiologie et Qualité Dessoins, F-59000,Lille, France
c
Université de Lille, EA 4489, Environnement Périnatal et Santé, F-59000, Lille,France

A R T I C L E I N F O A B S T R A C T

Article history: Objective: To evaluate the use of the intracervical balloon compared with locally applied prostaglandins
Received 10 December 2019 for cervical ripening for induction in patients with preterm premature rupture of membranes.
Received in revised form 13 March 2020 Methods: Monocentric, retrospective (from 2002 to 2017) observational cohort study of singleton pregnancies
Accepted 26 March 2020
complicated by preterm premature rupture of membranes and induced between 34 and 37 weeks. The primary
Available online 15 May 2020
outcome measure was balloon catheter efficiency evaluated by Cesarean section rate. Secondary outcomes
were : interval from induction to delivery, labor duration, oxytocin use, intrauterine infection rate, maternal
Keywords:
complications (i.e., postpartum hemorrhage and endometritis), and neonatal complications.
Preterm premature rupture of membranes
Induction
Results: 60 patients had cervical ripening with prostaglandins alone and 58 had balloon catheter.
Balloon catheter Demographic characteristics were similar between the groups, except for induction term and neonatal
Prostaglandins weight. There was not a significant difference in occurrence of Cesarean section rate (p = 0.14). Nor were
Intrauterine infection there significant differences in time from induction to birth (p = 0.32) or in intrauterine infection rate (p =
0.95). Labor duration was shorter (p = 0.006) and total oxytocin dose lower (p = 0.005) in patients induced
by prostaglandins alone. Concerning neonatal outcomes, there were more transfers to intensive care (p =
0.008) and more respiratory distress (p = 0.005) among newborns induced by prostaglandins.
Conclusion: Compared with locally applied prostaglandins, balloon catheter induction is not associated
with an increase of Cesarean section rate in patients with preterm premature rupture of membranes.
© 2020 Elsevier Masson SAS. All rights reserved.

Introduction
Preterm premature rupture of membranes (PPROM) compli-
cates 3% of pregnancies. [1] The primary risk from PPROM is
exposure to intrauterine infection (IUI), with incidence estimated
from 15% to 25% [2]. Management of PPROM is mainly based on
prevention until 34 weeks’ gestation and then induction is
considered between weeks 34 and 37, based on varying national
guidelines [2–4].
Cervical ripening and labor induction can be performed by
oxytocin, prostaglandins, or mechanical approaches (i.e., single or
double balloon catheter). The balloon catheter technique is
efficacious compared with other methods, with the advantage of
reducing uterine hyperstimulation, which is primarily responsible
for causing abnormal fetal heart rates. [5–7] Despite this, one
concern with using mechanical methods is infection risk. While the
efficacy and safety —including IUI risk— of intracervical balloons has
been confirmed for use with intact membranes [8], few studies have
examined balloon-related IUI in premature rupture of membranes
(PROM) [9–12]. Whether its effect is reduced in PPROM due to the
absence of any effect on the membrane —and thus on endogenous
prostaglandin secretion— is unknown.
Thus, the study objective was to evaluate effectiveness of the
balloon catheter for induction in PPROM and determine whether
balloon catheter for cervical ripening increases the Ceasarean
section rate, compared with locally applied prostaglandins. The
secondary objective was to assess the safety of the balloon catheter
and mainly IUI rate in PPROM.
Materials and methods

This was a monocentric, retrospective cohort study in Lille

* Corresponding author at: CHU Lille, Department of Obstetrics, Avenue Eugène
Avinée, F-59000,Lille, France. (tertiary care hospital), France, examining patient records kept
E-mail address: Alexane.tournier2@gmail.com (A. Tournier). from 2002 to 2017. Patients were included if they had a singleton

http://dx.doi.org/10.1016/j.jogoh.2020.101745
2468-7847/© 2020 Elsevier Masson SAS. All rights reserved.
2 A. Tournier et al. / J Gynecol Obstet Hum Reprod 49 (2020) 101745

pregnancy with PPROM before term (<35 weeks) and were considered statistically significant. Data were analyzed using SAS
induced, after more than a week of management, by either locally software (version 9.4; SAS Institute Inc., Cary, NC).
applied (vaginal) prostaglandins or intracervical balloon. Patients
were excluded in the case of intrauterine fetal death, if they were Ethics
induced for suspicion of IUI, and if they did not need cervical
ripening (Bishop > 6). The study was approved by the Comité local de la Commission
PPROM was clinically defined as fluid loss or ultrasound Nationale Informatique et Libertés (CNIL) (reference DEC16-210).
showing oligoamnios (maximum vertical pocket <2 cm). It was
confirmed with positive Actim Prom test (Medix Biochemica), Results
detecting the insulinlike growth factor binding protein-1 (IGFBP-
1). Following current standard of care, PPROM-diagnosed patients Over 211 patients induced for PPROM, 120 patients had an
received antenatal corticosteroids and prophylactic antibiotics unfavorable cervix and were induced between 34 and 37 weeks
(seven days of Amoxicillin), as soon as they were diagnosed. (Fig. 1). 91 patients had a bishop > 6 and were induced by oxytocin
PPROM management during the study period, prior to implemen- alone. Two patients were induced for suspicion of IIU and were
tation of homecare management, was conventional hospitaliza- excluded from the study. Therefore, 118 patients (55.9%) were
tion. [13] included : 60 in the vaginal prostaglandin group (50.8%) and 58 in
Labor induction occurred between 34 and 37 weeks, as the balloon catheter group (49.2%). Among the latter, 42 were
recommended by the American College of Obstetrics and induced by double balloon and 16 with single balloon. Twenty-
Gynecology. [2] Patients in the study had an unfavorable cervix nine (50%) patients induced by balloon catheter required a second
(Bishop score  6) and required cervical ripening, by either line of induction with prostaglandins. Demographics and
prostaglandin E2 or balloon catheter. There were two periods : the
primary mode of cervical ripening was prostaglandins (gel or
intravaginal device) until 2013, after which the intracervical
balloon became the method of reference and was systematically
used, whatever the bishop score, the fetal heart rate or the fetal
presentation. Balloon catheter remained in situ 12 h. The double
balloon type (Cook Cervical Ripening Balloon reference J-CRBS-
184000) was used initially, followed in 2015 by the single 50 mL
inflated balloon (Cook Universa Foley catheter Fr 16 reference
028518-CE), which has the same efficacy and a lower cost [14,15].
After the first ripening method, vaginal prostaglandins could be
used as second induction agent if cervix was still unfavorable.
Oxytocin was only used after the balloon catheter or the
prostaglandins, if contractions or cervical dilation was insufficient.
During labor, antibiotic prophylaxis with amoxicillin was system-
atic. Management was the same in patients with a previous
Cesarean delivery.

The primary study outcome balloon catheter efficiency evaluated by

Cesarean section rate

Secondary outcomes were: and interval from induction to

delivery, labor duration (latent phase, active phase i.e. dilation >
5 cm and second stage), oxytocin use, IUI rate, maternal
complications (i.e., postpartum hemorrhage and endometritis),
and neonatal complications (respiratory distress, hyaline
membrane disease, neonatal infection, intraventricular hemor-
rhage, necrotizing enterocolitis, neonatal death). IUI was
defined according to the criteria set by Higgins et al.: tempera-
ture >38  C on two occasions, or >39  C with fetal tachycardia
(>160 beats per minute for >30 min), purulent cervical
discharge, or maternal leukocytosis (>15,000 cells/mL). [16,17]
Endometritis was defined as a temperature >38  C associated
with uterine pain or purulent cervical discharge, and with no
other source of hyperthermia.

Statistical analyses

Data are presented as value (percentage) for categorical

variables and mean  standard deviation (SD) or median
interquartile range (IQR) for continuous variables. Normality of
distribution was checked graphically and using the Shapiro–Wilk
test. Between-groups comparisons were made using the Chi-
square test for categorical variables or Student’s t-tests (or Mann–
Whitney tests for non-Gaussian distribution) for continuous
variables. Statistical analyses used a two-tailed α, with p < 0.05 Fig. 1. xxx.
 A. Tournier et al. / J Gynecol Obstet Hum Reprod 49 (2020) 101745
pregnancy characteristics were similar between the groups except
for induction term and neonatal weight (Tables 1 and 3); induction
term differed between the groups, which was 35 weeks, 6 days
(range: 35 weeks, 2 days to 36 weeks, 3 days) for patients induced
by prostaglandins vs 36 weeks, 2 days (range: 36 weeks, 1 day to 36
weeks, 6 days) for patients induced by balloon catheter (p < 0.001).
Neonatal weight also differed with 2580 g for prostaglandins vs
2700 g for balloons (p = 0.017). Bishop score at induction was
comparable between the two groups: 3 (range: 2–4) for
prostaglandins alone vs 3 (range: 2–4) for balloon catheter (p =
0.87).
There was not a significant difference between-groups in
delivery mode (20.0% cesarean for prostaglandins group vs 10.3%
for balloon catheter group p = 0.14; Table 2). The time from
induction onset to birth did not differ significantly between the
prostaglandin (29 h) and balloon catheter (28 h) groups (p = 0.32).
Among the secondary outcomes, there was not a significant
difference in occurrence of IUI (11.7% for vaginal prostaglandins vs
12.1% for balloon catheter; p = 0.95). Labor duration among
patients induced by prostaglandins alone was shorter compared
with that of patients induced by balloon catheter (275 vs 283 min,
respectively; p = 0.006); this result was found for each labor stage.
Regarding labor characteristics, there was not a significant
between-groups difference in rate of oxytocin use, although a
higher total dose was observed for patients induced by balloon
catheter (1.3 IU vs 0.6 IU for the prostaglandin group; p = 0.005).
Table 3 shows neonatal outcomes based on induction method.
In the prostaglandin group, there were more transfers to intensive
care (22% vs 5.2% in the balloon catheter group; p = 0.008) and
more respiratory distress (16.7% vs 1.7% in the balloon catheter
group; p = 0.005).
Among the 11 cases of intrauterine infection, 5 bacteria were
found during the antenatal period using vaginal swab and 6
bacteria during the postpartum period. Among these cases, two
patients had both antenatal and postnatal bacteria, and this
bacterium was the same in one case. All patients had antibiotics
during labor. Among the intrauterine infection cases, two
presented maternal infection and one neonatal infection.
Discussion
PPROM management includes induction between 34 and 37
weeks’ gestation [2] and the primary complication of PPROM is IUI
risk. According to our study, induction by balloon catheter is not
associated with an increase of this risk compared with induction
by vaginal prostaglandins. Nor did we find a difference in delivery
mode or time from onset of induction to birth. However, labor
Table 1
Sample characteristics based on cervical ripening method.
Variable Prostaglandin group n = 60
Age (years) 25.5 (21.0
Prepregnancy BMI (kg/m2) 22.0 (19.0
Smoking 13 (21.7)
Nulliparous 25 (41.7)
Prior Cesarean delivery 2 (3.3)
IUGR 5 (8.3)
Obstetrical pathology 14 (23.3)
Premature labour, 6 (10.0)
Gestational diabetes, 5 (8.3)
Obstetric cholestasis 1 (1.7)
Gestational age at PPROM* (weeks) 31.9 (27.1
Positive bacteriological culture on vaginal swab at PPROM 5 (8.5)
Oligoamnios at PPROM 9 (15.0)
Gestational age at induction* (weeks) 35.9 (35.4
IUGR = intrauterine growth restriction.
Data expressed as n (%) or median* (interquartile range).
3
duration was shorter, and total dose of oxytocin lower, for patients
induced by prostaglandins alone, whereas superior neonatal
outcome was observed in the balloon catheter group.
Few studies have investigated induction methods in patients
with rupture of membranes prior to 37 weeks’ gestation; among
these, most have focused on the optimal gestational age for birth,
comparing expectative management to immediate delivery
between 34 and 37 weeks. [18–20] In those studies, induction
mode was either oxytocin or prostaglandins. Various national
guidelines do not recommend one induction method over another.
Rather, they draw conclusions based on the efficacy and
acceptability of oxytocin and prostaglandins, and on the relative
lack of data on balloon catheter [2–4,21].
Mechanical induction by single or double balloon catheter has
been primarily discussed in the contexts of infection risk and
mechanism of action. The main concern is a theoretical risk of
infection due to the presence of a foreign body in the cervix,
particular when the membranes have ruptured. [22] McMaster
et al. conducted a meta-analysis of 26 randomized trials with 5563
patients with intact membranes, finding a similar rate of infection
between Foley and prostaglandin groups; each had approximately
7.2% IUI, 3.5% endometritis, and 3.5% neonatal infections [8].
Amorosa et al. compared use of a Foley catheter with oxytocin vs
oxytocin alone in a randomized trial of 128 patients with
premature rupture of membranes (PROM) after 34 weeks’
gestation [11]. These authors found no difference in delivery
mode nor in induction-to-delivery time between the groups, with
no significant difference in IUI rate (10% in the Foley group vs 5% in
the oxytocin alone group; p = 0.31). Conversely, in a randomized
trial of 201 patients with PROM after 34 weeks’ gestation, Mackeen
et al. found an increased IUI rate in the oxytocin + Foley group
compared with oxytocin alone (8% vs 0%, respectively; p < 0.01).
The Cesarean section rate (27% vs 19% respectively, p = 0.35) and
the induction–delivery delay was similar between groups in that
study. [12] After 37 weeks’ gestation, Cabrera et al. retrospectively
evaluated 42 patients induced by Foley, compared with 82 induced
by oxytocin alone [10]. Using logistic regression, that group found
the occurrence of IUI to be associated with nulliparity and use of
internal tocometry, rather than use of balloon catheter. In a
randomized trial of 202 patients, Kruit et al. compared induction
following PROM after 37 weeks by Foley vs prostaglandins and did
not find any difference in either rate of cesarean delivery rates
(23.6 vs. 18.2% respectively ; p = 0.36), time from induction to birth
(1311 vs. 1,435 min; p = 0.31) or rate of IUI (2.2 vs 2%, respectively; p
= 1.00) [9].
The second concern with balloon catheter in PPROM is its
efficacy when the membranes are ruptured. Indeed, rupture of
Balloon group n = 58 p value
31.0) 28.0 (24.0 34.0) 0.094
26.0) 22.0 (20.0 25.0) 0.37
9 (15.5) 0.39
32 (55.2) 0.14
3 (5.2) NA
4 (6.9) 1.00
9 (15.5) 0.28
2 (3.4) NA
5 (8,6) NA
0 NA
32.8) 29.2 (25.1 32.6) 0.22
4 (7.0) 1.00
5 (8.6) 0.28
36.3) 36.3 (36.1 37.0) <0.001
4 A. Tournier et al. / J Gynecol Obstet Hum Reprod 49 (2020) 101745

Table 2
Induction characteristics in PPROM patients based on cervical ripening method.

Variable Prostaglandin group n = 60 Balloon group n = 58 p value

Bishop score* 3.0 (2.0 4.0) 3.0 (2.0 4.0) 0.87
Need for a second line of induction 24 (40.0) 29 (50.0) 0.27
Number of prostaglandins* 1.00 (1.00 2.00) 1.00 (0.00 2.00) <0.001
Time from onset of induction to delivery room* (hours) 24.0 (8.2 38.8) 21.8 (14.8 39.5) 0.48
Time from induction to delivery* (hours) 29.0 (13.3 48.9) 28.0 (20.9 46.7) 0.32
Oxytocin use 33 (57.9) 41 (71.9) 0.12
Total dose of oxytocin* 0.6 (0.3; 2.0) 1.3 (0.8; 2.8) 0.005
Labor duration (min)* 275.0 (150.0 360.0) 383.0 (234.0 494.0) 0.006
Latent phase * 180.0 (90.0 300.0) 240.0 (180.0 360.0) 0.027
Active phase * 40.0 (20.0 60.0) 60.0 (40.0 80.0) 0.026
Second stage * 11.0 (5.0 28.0) 28.0 (14.0 48.0) 0.006
Instrumental delivery 6 (10.0) 8 (13.8) 0.32
Cesarean delivery 12 (20.0) 6 (10.3) 0.14
Intrauterine infection 7 (11.7) 7 (12.1) 0.95
Regional anesthesia 54 (90.0) 56 (96.5) 0.27
Postpartum hemorrhage 7 (11.7) 7 (8.6) 0.58
Postpartum endometritis 2 (3.3) 2 (3.4) NA

Data expressed in n (%) or median* (interquartile range).

NB: for oxytocin removal of Cesareans prior to transport to birth room (N = 114 avec n prostaglandin = 57 and n ballon = 57).

Table 3
Neonatal outcomes in PPROM patients based on cervical ripening method.

Variable Prostaglandin group n = 60 Balloon group n = 58 p value

Neonatal Weight (grams)* 2580 (2345 ; 2755) 2700 (2540 ; 2900) 0.017
5-min Apgar score < 5 1 (1.7) 0 (0.0) NA
Arterial cord pH < 7.101 3 (5.4) 2 (3.8) NA
Admission to ICU2 13 (22.0) 3 (5.2) 0.008
Respiratory distress 10 (16.7) 1 (1.7) 0.005
Neonatal infection 1 (1.7) 1 (1.7) NA
Hyaline membrane disease 7 (11.7) 2 (3.4) 0.16

ICU = Intensive Care Unit.

Data expressed as n (%) or median* (interquartile range).
1
9 missing from 118.
2
1 missing from 118.

membranes is associated with local secretion of prostaglandins,
facilitating spontaneous labor. However, the balloon catheter
also aids secretion of local prostaglandins, via membrane
stripping. Due to the mechanism of rupture, it is possible that
the optimal physiological amount of prostaglandins has already
been reached. The effect of the balloon would therefore be
limited. In our analyses, we observed balloon catheter induction
to have the same efficacy as prostaglandins. Labor lasted 8 min
longer in the balloon catheter group, which is clinically
negligible. Consistent with Wang et al., we observed a decrease
in the use of oxytocin in prostaglandin induction compared with
a mechanical method. [7]
This study is original since other authors studied induction with
balloon catheter in term PROM and never in PPROM, to our
knowledge. It is all the more interesting as risk of IUI increase with
length of latency. Although our novel study revealed valuable
findings on the safety and efficacy of balloon catheter induction in
the management of PPROM, it was not without several limitations.
First, the two groups were not strictly comparable because their
induction terms differed by 3 days (although this difference is not
clinically meaningful) and the neonatal weight also differed. It
might be the reason of the statistical difference in neonatal
outcomes. Second, our sample size was relatively small, [10,11] and
thus did not allow analysis of rare events (e.g., endometritis,
neonatal infections). A larger number of patients may have
revealed a significant difference on outcomes such as delivery
mode. In fact, there were twice as many Cesarean deliveries in the
prostaglandin group (20%) than in the balloon group (10%; p = 0.14).
The sample size for the outcomes are not of sufficient number to
rule out a type II error for the small differences in the variables
measured. Third, there is a classification bias given that 50% of the
balloon group received prostaglandins. A subgroup analysis was
not statistically relevant considering our sample size. Forth, we
cannot rule out the possibility of an IUI classification bias in the
prostaglandin group; indeed, hyperthermia is a known side effect
of dinoprostone. [5] Moreover, the assessment of the IUI was not
blinded so views of the clinicians could affect the diagnosis of IUI.
Nevertheless, we used a standardized IUI definition, based on the
criteria by Higgins et al. and objective data [16]. Finally, a mid-
study change in standard practice within our center, implementa-
tion of homecare management, may have affected our patients’
microbial ecology.
Conclusion
Compared with locally applied prostaglandins, induction by
intracervical balloon is not associated with a significantly higher
risk of Cesarean section. Thus, balloon catheter appears to be an
option for PPROM management. These results should be confirmed
in a randomized study with a larger sample.
Funding
Funding was not obtained for this study.
Declaration of Competing Interest
The authors report no conflict of interest.
 A. Tournier et al. / J Gynecol Obstet Hum Reprod 49 (2020) 101745
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