|

Received: 22 August 2018    Accepted: 12 August 2019

DOI: 10.1111/aogs.13712

ORIGINAL RESEARCH ARTICLE

Balloon catheter vs oxytocin alone for induction of labor

in women with a previous cesarean section: A randomized
controlled trial

Mélie Sarreau1,2  | Helene Isly3,4 | Patrice Poulain3,4 | Brigitte Fontaine2 |

Olivier Morel5,6 | Pascal Villemonteix7 | Pierre Mares8,9 | Eve Mousty8,9 |
Alain Godard10 | Stephanie Ragot11,12,13 | Fabrice Pierre1,11
1
Department of Obstetrics and Gynecology, University Hospital of Poitiers, Poitiers, France
2
Department of Obstetrics and Gynecology, Regional Hospital of Angoulême, Angoulême, France
3
Department of Obstetrics and Gynecology, University Hospital of Rennes, Rennes, France
4
Faculty of Medicine, University of Rennes, Rennes, France
5
Department of Obstetrics and Gynecology, University Hospital, Nancy, France
6
Faculty of Medicine, University of Lorraine, Nancy, France
7
Department of Obstetrics and Gynecology, Regional Hospital of Nord de Sèvres, Bressuire, France
8
Department of Obstetrics and Gynecology, University of Nîmes, Nîmes, France
9
Faculty of Medicine, University of Nîmes, Nîmes, France
10
Department of Obstetrics and Gynecology, General Hospital Camille Guérin, Chatellerault, France
11
Faculty of Medicine, University of Poitiers, Poitiers, France
12
Clinical Epidemiology and Health Research Center, University of Poitiers, Poitiers, France
13
National Health and Medical Research Institute (INSERM), CIC 1402, Poitiers, France

Correspondence
Mélie Sarreau, Department of Obstetrics
and Gynaecology, University Hospital of
Poitiers, 2 Rue de la Milétrie, 86021 Poitiers,
France.
Email: meliesarreau@hotmail.com
Funding information
The study was supported by the
“Programme Hospitalier de Recherche
Clinique Interrégional 2010” of the French
Ministry of Health (A00409‐30).
Abstract
Introduction: To compare the efficacy and maternal‐neonatal morbidity between
balloon catheter and oxytocin for induction of labor in women with a previous cesar‐
ean section and an unfavorable cervix.
Material and methods: This open‐label randomized controlled trial took place in
seven French hospitals. Inclusion criteria were medical indication for labor induc‐
tion in pregnant women, ≥37 weeks, with lower segment cesarean section, Bishop
score ≤4, no pre‐labor rupture of membranes, singleton fetus in cephalic presenta‐
tion. Women were allocated randomly to induction with a 50‐mL balloon catheter for
12 hours or a low‐dose oxytocin infusion. Primary outcome was the rate of vaginal
birth. Secondary outcomes were maternal and neonatal complications.
Results: The study enrolled 204 women from 26 December 2010 to 31 December
2013: 101 were allocated to receive balloon catheter and 103 to oxytocin. Vaginal
birth rate was 50% (n = 51) in the balloon catheter group vs 37% (n = 38) in the ox‐
ytocin group (P  =  0.050). Maternal and neonatal morbidity did not differ between
balloon catheter and oxytocin groups: two uterine dehiscences vs one, one vs four

Abbreviations: BC, balloon catheter; PROM, premature rupture of membranes; VBR, vaginal birth rate.

Acta Obstet Gynecol Scand. 2019;00:1–8. © 2019 Nordic Federation of Societies |  1

wileyonlinelibrary.com/journal/aogs  
of Obstetrics and Gynecology
 |
2       SARREAU et al.

maternal infections, five vs two hemorrhages and 11 vs five neonatal transfers, respec‐
tively. Heterogeneity of treatment effect for vaginal delivery was observed across ini‐
tial Bishop scores. Balloon catheter was more effective for low values of bishop score.
Conclusions: Balloon catheter tended to be associated with a higher probability of vag‐
inal delivery as compared with low‐dose intravenous oxytocin when used for induction
of labor in women with a previous cesarean section and low Bishop score at induction.

K E Y WO R D S
balloon catheter, cesarean section, induction of labor, oxytocin, vaginal delivery

1 |  I NTRO D U C TI O N
The frequency of cesarean sections has been increasing worldwide
in recent decades, as noted by the World Health Organization and
numerous national societies of gynecology and obstetrics.1,2
In the last guidelines of the Royal College of Obstetricians and
Gynaecologists, planned vaginal birth after cesarean (VBAC) was
considered appropriate for and a good option to offer to the majority
of women with a singleton pregnancy.3
Induction of labor after cesareans is generally accepted in var‐
ious national guidelines but is associated with an increased risk of
3-5
uterine rupture, estimated at near 1%. Moreover, an unfavor‐
able cervix (cervical effacement  ≤25%, cervical dilation 0  cm or
posterior cervix) is frequently observed at the onset of induction
and is known to increase the risk of cesarean delivery. 6 Cervical
ripening can be obtained by mechanical or pharmacological meth‐
ods. The Foley balloon catheter (BC) is an old mechanical method
reported to be associated with less hyperstimulation of the uterus
and fewer pathological fetal heart rate abnormalities than pros‐
7,8
taglandins. Regarding efficacy, vaginal birth rates (VBR) were
comparable with these two methods in women with no previous
cesareans.7-10
According to international, European and a national consensus
conference, in women with prior cesarean section, prostaglandins
are not prohibited despite the increased risk of uterine rupture asso‐
ciated with their use; however, they should be used with caution.3-5
Regarding BC use in this population, guidelines do not prohibit it but
3-6,11,12
there are no data to recommend it.
In this study we aimed to compare efficacy and maternal‐neona‐
tal morbidity between BC and oxytocin alone for induction of labor
on unfavorable cervix in women with prior cesarean section.
2 | M ATE R I A L A N D M E TH O DS
This multicenter, prospective, open‐label, randomized controlled
clinical trial took place in seven French hospitals from 26 December
2010 to 31 December 2013.
Eligible participants were pregnant women at a term exceeding
37 weeks, who had a medical indication for induction of labor, a single
Key message
This work justifies the recommendation of the use of a bal‐
loon catheter as a method of choice for induction of labor
for women with a previous cesarean and low Bishop score
as an alternative to low‐dose oxytocin.
previous cesarean delivery with a lower segment cesarean section,
a singleton pregnancy in vertex presentation, an unfavorable cervix
(Bishop score ≤4) and no premature rupture of membranes (PROM).
Women were not included if they were younger than 18  years
old or if they met one of the following exclusion criteria: placenta
previa, PROM, uterine scar other than lower segment cesarean sec‐
tion, cervical infection (except carriage of Streptococcus agalactiae),
multiple pregnancy, breech or transverse presentation, indication
for a repeat cesarean or a latex allergy.
All women with a previous cesarean receiving antenatal care
during the third trimester of pregnancy received written informa‐
tion explaining the study aim. When induction of labor was medically
indicated, women who agreed to participate were prospectively
included.
Women were randomly assigned by a centralized web‐based
management system (Clinsight, Ennov; SAS Institute) to cervical rip‐
ening and induction of labor with either a BC or oxytocin perfusion
alone, in a 1:1 ratio. The randomization sequence was computer‐
generated with variable blocks of four, stratified by center.
To avoid selection bias, healthcare providers (investigators,
nurses and midwives) and patients were masked to group assign‐
ment until inclusion criteria were confirmed on the website.
A sterile 18F balloon catheter (ref. 1859H18; Bard, Covington,
GA, USA) was introduced into the cervix of the women allocated
to its use, with the aid of a vaginal speculum after cervical cleaning
with an aseptic solution. Several of the maternity units were already
familiar with the use of these BC for cervical ripening. Four of them
participated in our retrospective preliminary study, which used a
similar type of BC and method of placement.13 BC was placed on
the side opposite to the placenta insertion site. It was then inserted
up to the internal cervical os and inflated with 50 mL sterile water,
SARREAU et al.
without applying any traction. After placement, the fetus was mon‐
itored with cardiotocography for 2 hours to evaluate tolerance. The
cervix was examined after BC removal, 12  hours after placement,
or after either the onset or the spontaneous expulsion of the BC
into the vagina. Even if the Bishop score remained <7 after 12 hours,
induction was pursued by oxytocin perfusion. If PROM occurred
during or after the balloon placement, the BC was removed. The
woman remained in her randomization group, as this was an ex‐
pected side effect, and usual care continued. Based on the severity
of bleeding, the clinician could induce labor by oxytocin perfusion or
perform a cesarean section.
Oxytocin perfusion was the only means used for both cer‐
vical ripening and induction of labor in the oxytocin group. In the
BC group, oxytocin perfusion use was left to the discretion of the
obstetrician.
In both groups, oxytocin perfusion with a serum pump began at
1‐4 mIU or 0.1‐0.4 mL/min, and oxytocin augmentation was titrated
so that it did not exceed the maximum rate of four contractions per
10‐minute period. In women with vaginal carriage of S. agalactiae or
PROM, antibiotic prophylaxis with amoxicillin began before induc‐
tion of labor. Amniotomy was also left to the discretion of the obste‐
trician. Whatever the allocated method, a 12‐hour delay was allowed
in cases of PROM without spontaneous labor, except if the Bishop
score was favorable (≥7). If Bishop score was  <7 after 12  hours of
PROM, labor was induced by oxytocin perfusion anyway.
Primary outcome was VBR. Thus, a vaginal delivery defined the
success of treatment and a cesarean delivery a failure of treatment.
Secondary outcomes were maternal intrapartum and postpar‐
tum morbidity, neonatal morbidity, and maternal pain and satisfac‐
tion, evaluated by a visual analog scale. Maternal morbidity was
defined by instrumental vaginal delivery, uterine hyperstimula‐
tion (>6 contractions per 10 minutes or a contraction lasting more
than 3  minutes), temperature during labor  >38°C or postpartum
infection (urinary or endometritis confirmed by bacteriological
sample), fetal heart rate abnormalities (International Federation
of Gynecology and Obstetrics [FIGO] classification), postpartum
hemorrhage (>1000  mL), transfusion, hemostatic surgery (vascu‐
lar ligature, hysterectomy), thrombosis or uterine rupture. Other
maternal data recorded were time from the outset of the allocated
treatment to delivery, cervix dilation at placement of epidural
analgesia, doses and infusion rate of oxytocin, and duration of
hospitalization.
Neonatal morbidity was defined by a 5‐minute Apgar score <7,
arterial cord blood pH  <7 or lactates  >5  mmol/L, admission to the
neonatal intensive care unit, respiratory distress, meconial inhala‐
tion, suspected infection (confirmed by a positive bacteriologic sam‐
ple or a C‐reactive protein value >20 mg/L).
2.1 | Statistical analyses
Assuming that in the population of women with a prior cesarean sec‐
tion and receiving oxytocin perfusion to induce labor, the VBR would
be 60%, we calculated that a sample size of 106 women per group
|
      3
would be needed to show an increase in the vaginal delivery rate to
80% with the use of a BC at a two‐sided alpha level of 0.05 and a
study power of 90%.
All analyses were performed on an intention‐to‐treat basis.
Quantitative data are described by means and standard devia‐
tions (SD) or medians and interquartile range. Categorical data are
presented as frequencies and percentages.
Comparison of vaginal delivery rate (primary outcome) between
BC and oxytocin groups was performed using a chi‐square test. We
did a multiple logistic regression for the primary outcome. Covariates
were selected in a backward selection procedure if P < .10 in the uni‐
variate analysis. Interactions between selected variables and treat‐
ment were tested one by one.
All comparisons were two‐sided with P <0.05 defined as statis‐
tically significant. We used SAS software version 9.4 (SAS Institute)
for all the analyses.
2.2 | Ethical approval
The study protocol was approved for all centers by the ethics com‐
mittee at Poitiers University Hospital (Ethics Committee Ouest III,
Poitiers, France, registration number 2010‐A00409‐30), and the
study was conducted in compliance with Good Clinical Practice
guidelines. All participants gave written informed consent before
inclusion in the trial. The trial was registered in the international
clinical trial registry ClinicalTrials.gov, Identifier: NCT01711060.
3 | R E S U LT S
From 26 December 2010 to 31 December 2013, 207 women were
assessed for eligibility and 205 were included and randomized.
Due to one consent withdrawal, the analysis considered 101
women in the BC group and 103 women in the oxytocin group
(Figure 1).
Baseline characteristics were similar between the two groups
(Table  1). A large majority of women had no history of vaginal de‐
livery. The most frequent indication for induction of labor was post‐
term pregnancy.
The VBR was 50% (n = 51) in the BC group vs 37% (n = 38) in the
oxytocin group (P = 0.050).
Time from the onset of the allocated treatment was around
12  hours longer as expected between two methods. Time from
placement of epidural analgesia to delivery was similar in both
groups. Cervical dilation was greater at epidural placement in the
BC group (Table 2).
In the BC group, the median Bishop score increase between BC
insertion and the end of cervical ripening was 3.0 [1.0; 4.0] points.
Failure of induction was the most frequent indication for cesarean
delivery and was significantly less frequent in BC group. The frequency
of fetal distress did not differ between the two groups (Table 2).
Maternal and neonatal morbidity did not differ significantly be‐
tween the two groups Table 2. Adverse outcomes were two uterine
 |
4       SARREAU et al.

Enrolment

Assessed for eligibility (n = 207)

Excluded (n = 2)
♦ Not meeting inclusion criteria (n = 2)

Randomized (n = 205)

Allocation

Allocated to BC intervention (n = 101) Allocated to oxytocin infusion intervention (n = 104)

♦ Received allocated intervention (n = 95)
♦ Did not receive allocated intervention (n = 6)
- Spontaneous labour before intervention (n = 4)
- Failure to place BC (n = 1)
- Refusal of the woman to place the catheter (n = 1)
♦ Received allocated intervention (n = 102)
♦ Did not receive allocated intervention (n = 2)
- Spontaneous labour (n = 1)
- Overbooked labour ward (n = 1)

Follow-Up

Discontinued intervention (n = 3) No lost to follow-up

♦ Removal for pain (n = 1) No discontinued intervention

♦ Removal for bleeding (n = 1)
♦ PROM while device in place (n = 1)

Analysis

No exclusion for intention to treat analysis Excluded from intention to treat analysis
(withdrew consent) (n = 1)

F I G U R E 1   Study flow chart. BC, balloon catheter; PROM, premature rupture of membranes. *Recruitment stopped before the 212
planned women were included because there was no more funding [Colour figure can be viewed at wileyonlinelibrary.com]

dehiscences occurring during labor in the BC group compared with
one in the oxytocin group. No complete uterine rupture was ob‐
served. One woman in the BC group had an infection, compared
with four in the oxytocin group, and respectively five vs two hem‐
orrhages, 11 vs five neonatal intensive care unit transfers, and four
vs one neonatal infection Table 2). Other adverse outcomes were
complications of cesareans, independent of the method of labor in‐
duction: one uterine laceration during surgery, one bladder injury,
one scar abscess of the cesarean incision and one post‐cesarean
hemoperitoneum that required secondary surgical revision.
Minor adverse outcomes in the BC group were seven cases of
bleeding (<20  mL), with one of these seven cases requiring BC re‐
moval, one a failure to place the catheter, one early removal of BC
for pain, five deflation of BC for pain (50 mL to 30 mL) and one a re‐
moval due to PROM. Labor began before 12 hours of BC placement
for 23 women. Although only half the obstetricians had previously
used this device, 92% found it easy to place.
Maternal pain evaluated by the visual analog scale did not differ
between the BC and oxytocin groups and satisfaction was roughly
the same in the two groups (Table 2).
Independent variables considered in the multivariate analysis to
explain vaginal delivery were allocated mode of induction of labor,
body mass index, previous vaginal delivery, insulin‐dependent diabetes
mellitus, Bishop score, fetal distress during labor and center.
Testing interaction between treatment and each of these vari‐
ables highlighted a significant interaction between treatment and
Bishop score (P =0.0095); none of the other interactions were sig‐
nificant (P =0.2076 with body mass index, P =0.7428 with previous
vaginal delivery, P  =0.9041 with insulin‐dependent diabetes melli‐
tus; P =0.2724 for fetal distress during labor). Regarding the result
of the multivariate analysis, the association between treatment and
vaginal delivery was not interpretable for the overall population due
to the interaction. Figure  2 shows the heterogeneity of the effect
of BC according to Bishop score: vaginal delivery was enhanced by
BC for low values of Bishop score, only. Dichotomization of Bishop
score according to its median, which was equal to 2, showed a VBR
significantly higher with BC in women with a Bishop score ≤2: 52%
(26/50) vs 22% (13/58) without BC (P  =  0.001). In the subgroup
with a Bishop score >2 VBR did not differ between the two treat‐
ments: 49% (25/51) in the BC group and 56% in the oxytocin group
(P = 0.52).
4 | D I S CU S S I O N
In this multicenter, randomized, open‐label trial among pregnant
women with a previous cesarean delivery and a medical indication
for cervical ripening and induction of labor, vaginal delivery was
SARREAU et al. |
      5

TA B L E 1   Baseline characteristics of participants, according to cesarean section and unfavorable cervix. The strengths of our trial
treatment group included the multicenter design, the electronic randomization strat‐

Balloon catheter Oxytocin egy and the intention‐to‐treat‐analysis. Another original feature of
  (n = 101) (n = 103) our study was the assessment of the women's satisfaction regarding
labor induction and perceived pain,
Maternal age (years; mean ± SD) 30.9 ± 4.7 31.8 ± 5.2
The past decade has witnessed growing interest in the use of
Body mass index (kg/m²; mean ± SD) 27.3 ± 6.2 26.7 ± 5.9
Foley or BC to induce labor. 8,14-17 Few studies have examined the
Previous vaginal delivery
efficacy of this mechanical method in women with a previous cesar‐
0 79 (78%) 82 (80%)
ean.13-18 Moreover, many of those studies were retrospective and
1 10 (10%) 13 (13%)
included women at a lower risk of cesarean than ours; in particular,
≥2 12 (12%) 8 (8%) women with a Bishop score <6 and with several vaginal births.19 In a
Gestational age (weeks; median [IQR]) 40 [38‐41] 41 [39‐41] randomized study including 70 women, Ziyauddin et al14 reported a
Gestational age ≥41 weeks 47 (47%) 55 (53%) vaginal delivery rate at 71% in the BC group and 60% in the prosta‐
Indications for prior cesarean glandin groups. Cohort studies of vaginal delivery after induction of
Failure to induce labor 6 (6%) 12 (12%) labor by BC found a VBR of 71% of the 208 Dutch women studied
(dilation <5 cm) retrospectively by Joswiak et  al,15 in the subgroup of 135 women
Failure to progress (first or second 29 (29%) 22 (21%) induced with a BC in a prospective French study by Sananès et al16
stage) and 54% in our retrospective study of 151 women.13 The average
Fetal distress 28 (28%) 29 (28%) VBR in the more recent systematic review of Kehl et al was 56.4%.18
Elective 38 (38%) 40 (39%) Our study observed a low rate of failure (3%) (including failure
Interval between previous cesar‐ 41 [31; 73] 48 [33; to insert, PROM, bleeding) similar to that reported in the literature.7
ean and delivery of this pregnancy 69] No safety difference was found between the two tested groups.
(months; median [IQR])
The risk of uterine rupture has been described to be lower with BC
Indications for induction of labor
than with prostaglandins.11,12,18,20-22 Nonetheless, most studies do
Prolonged pregnancy 47 (46%) 45 (44%) not clearly describe the severity of the rupture and no distinction
Hypertensive disorders 13 (13%) 17 (16%) was made between complete ruptures (tears extending across the
Intrauterine growth restriction 11 (11%) 8 (8%) entire thickness of the uterine wall) and incomplete ruptures or de‐
Insulin‐dependent diabetes mellitus 17 (17%) 12 (12%) hiscences (myometrial tears, with the peritoneum and membranes
Macrosomia 4 (4%) 2 (2%) remaining intact). No complete ruptures occurred in our study; we
No fetal movement 3 (3%) 8 (8%) reported two uterine dehiscences identified during labor in the BC
Other pathological pregnancy 6 (6%) 11 (11%) group and one in the oxytocin group; this is consistent with an es‐
(cholestasis, maternal pathology, timated rate after labor induction of 1.2%.18,20-22 Due to the low
thrombocytopenia, alloimmuniza‐ number of participants and the low expected frequency of com‐
tion, antenatal fetal pathology)
plete rupture, our study did not have enough power to show any
Carriage of Streptococcus agalactiae 18 (18%) 12 (12%) difference between the two groups regarding this severe and rare
Initial Bishop score (median [25th; 3 [1; 3] 2 [1; 3] complication.
75th])
Some studies have reported an increased risk of neonatal in‐
Note: Prolonged pregnancy: 41 weeks, or 41 weeks + 2 or + 4 or fections and endometritis associated with BC, with quite impre‐
6 days, depending on the study center. Hypertensive disorders were
cise infection assessments. 23 Carefully standardizing investigators’
defined as hypertension before or during pregnancy or preeclampsia.
practices for streptococcus screening, antibiotic prophylaxis and the
Intrauterine growth restriction was defined as estimated fetal weight
<3rd percentile. definition of infection, we did not find any increase in the risk of
Abbreviation: IQR, interquartile range. infection in the BC group.
Our study has several limitations. When planning the study, we
more frequent with BC than with oxytocin alone for the overall assumed a VBR of 60% in the group with oxytocin alone, based on
study population. However, treatment effect was heterogeneous results from studies of women with a Bishop score <7.14-18,20-22 Our
across initial Bishop scores for vaginal delivery and BC seemed to be results found a substantially lower rate (37%), undoubtedly due to the
effective for low values of Bishop score only. Bishop score inclusion criterion we used (≤4). Nonetheless, we had an
We deliberately did not plan a comparison with prostaglandins, acceptable power of 82% to show an increase of 20% in the VBR (as
as their use might expose participants to a higher risk of uterine rup‐ planned in our protocol) from this rate of 37% among 204 women.
ture. We considered such a risk unacceptable. Another methodological limitation is the risk of bias linked to
To our knowledge, our study is one of the only randomized con‐ the absence of blinding. Nonetheless, there are clear and explicit
trolled trials that has sought to determine the efficacy of BC for criteria for cesarean delivery in this context and we consider it
labor induction in such a large population of women with previous improbable that the decision to perform a cesarean was influenced
 |
6       SARREAU et al.

TA B L E 2   Outcomes and other fetal and maternal data in the two randomized treatment groups: intention‐to‐treat unadjusted analysis

Balloon catheter Oxytocin Odds ratio or Absolute differ-

  (n = 101) (n = 103) ence estimate (95% CI) P

Delivery

Vaginal delivery (Primary outcome) 51 (50%) 38 (37%) 1.74 [1.00‐3.05] 0.050

Operative vaginal delivery 15/51 10/38    

Indication for cesarean section

Failure to induce labor (cervix <5 cm) 12/50 (24%) 33/65 (50%) 0.31 [0.14‐ 0.69] 0.0005

Failure to progress (first or second stage) 19/50 (38%) 17/65 (26%) 1.73 [0.78‐ 3.83] 0.66

Fetal distress 18/50 (36%) 14/65 (21%) 2.05 [0.90‐ 4.68] 0.40

Other 1/50 1/65   0.99

Maternal morbidity

Maternal intrapartum infection

Temperature > 38°C during labor 7 (7%) 4 (4%) 1.84 [0.52‐ 6.50] 0.33

Suspected intrapartum infection 1 (1%) 4 (4%) 0.25 [0.03‐ 2.25] 0.37

Postpartum hemorrhage (>1000 mL) 5 (5%) 2 (2%) 2.63 [0.50‐ 13.88] 0.24

Intensive care unit discharge 0 0    

Other maternal complications

Partial uterine rupture 2 (2%) 1 (1%) 2.06 [0.18‐ 23.09] 0.62

Complete uterine rupture 0 0    

Cord prolapse 1 (1%) 2 (2%) 0.50 [0.04‐ 5.66] 0.99

Transfusion 0 1 (1%) — 0.99

Hemostatic surgery/uterine artery embolization 0 1 (1%) — 0.99

Uterine hyperstimulation 0 1 (1%) — 0.99

Neonatal morbidity

Pathological fetal heart (FIGO classification) 22 (22%) 17 (17%) 1.41 [0.70‐ 2.84] 0.40

Apgar score 5 min ± SD 10 ± 1 10 ± 1 1.24 [0.79‐ 1.95] 0.50

Apgar score 5 min <7 0 2 — 0.50

pH cord <7.0 (n = 151)a  0/76 1/75 — 0.31

pH cord <7.10 (n = 151)a  3/76 7/75 0.40 [0.10‐ 1.61] 0.18

Transfer to ICU 11 (11%) 5 (5%) 2.40 [0.80‐ 7.16] 0.11

Complications with or without transfer to ICU

Respiratory distress 3 (3%) 8 (8%) 0.36 [0.09‐ 1.41] 0.13

Meconium inhalation 0 0    

Suspected infection 4 (4%) 1 (1%) 4.21 [0.46‐ 38.30] 0.38

Other (antenatal or congenital fetal pathology) 8 (8%) 9 (9%) 0.90 [0.33‐ 2.43] 0.82

Other fetal and maternal data

Epidural analgesia 90 (91%) 92 (90%) 0.98 [0.40‐ 2.37] 0.86

Dilation at epidural placement (cm; ± SD) 2.9 ± 1.5 1.8 ± 1.3 1.1 [0.7‐ 1.5] <0.0001

Time from the outset of the allocated treatment to delivery (hours; 6.3 ± 3.1 6.6 ± 3.9 −0.3 [−1.3 to 0.7] 0.82
±SD)

Duration between beginning of treatment until delivery (hours) 20.2 ± 5.4 8.5 ± 3.0 11.7 [10.5‐ 12.9] <0.0001
(n = 92/100)

Oxytocin (IU; ± SD) (n = 80/83) 3.3 ± 2.9 4.4 ± 7.4 −1.1 [−2.8 to 0.6] 0.34b

Duration of hospitalization (days) 4.9 ± 1.6 5 ± 1.6 0.94 [0.79‐ 1.12] 0.45

Neonatal weight (g; ± SD) 3347 ± 577 3402 ± 527 55 [−97 to 207] 0.48

Pain evaluation during procedure (mean ± SD) 3.0 ± 2.6 3.1 ± 2.8 −0.1 [−0.8 to 0.6] 0.38

Satisfaction regarding labor induction (VAS/10) 6.9 ± 3.1 6.9 ± 3.3 0.0 [−0.9 to 0.9] 0.75

Note: Failure to induce labor was defined as no modification of a 5‐cm or less dilated cervix for more than 5 hours despite regular contractions and
standardize oxytocin use.
Abbreviations: ICU, intensive care unit; VAS, visual analog scale.
a
11 missing values for neonatal cord gases and 42 cases with lactates reported instead of pH (lactates >5: 3/20 in BC vs 6/22 in oxytocin group).
b
This comparison was not interpretable due to the many missing data for oxytocin doses.
SARREAU et al.
ORCID
Mélie Sarreau  https://orcid.org/0000-0003-4852-1465
REFERENCES
F I G U R E 2   Vaginal birth rate in balloon catheter or oxytocin
group, according to Bishop score at inclusion. Black bars represent
balloon catheter group and grey bars represent oxytocin group.
Numbers between brackets represent: number of women with
vaginal delivery/total number of women in the treatment group of
the stratum
by the method of induction of labor. A third methodological limita‐
tion is that we did not anticipate the presence of an interaction be‐
tween treatment and Bishop score and did not plan to analyze the
results in sub‐groups defined a priori according to Bishop score.
A balloon marketed specifically for the induction of labor exists, but
at the time of the study, its manufacturer did not recommend its use in
women with a previous cesarean. We carefully chose the protocol of
use, taking into account both published data24-26 and our own experi‐
ence.13 We planned to take into consideration tolerance by inflating the
BC with only 50 mL sterile water and keeping it in place for 12 hours.
Data show that 80 mL inflation for 24 hours is more painful and yields a
similar cesarean rate even if it decreases the time of labor induction.24-28
5 | CO N C LU S I O N
Our study shows that in this population of women with a previous
cesarean, use of a BC seems to be effective and might make it pos‐
sible to avoid the use of prostaglandins in women with an unripened
cervix (Bishop score 0‐2).
Further research is needed to investigate the safety of this
promising mechanical method and also its efficacy and cost‐ef‐
fectiveness in specific indications (such as intrauterine growth re‐
striction). A randomized control trial in obese women would be of
particular interest in view of the lack of efficacy of prostaglandins
in this population. 29
AC K N OW L E D G M E N T S
We thank Joe Ann Cahn for editing the manuscript.
C O N FL I C T O F I N T E R E S T
None.
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How to cite this article: Sarreau M, Isly H, Poulain P, et al.
Balloon catheter vs oxytocin alone for induction of labor in
women with a previous cesarean section: A randomized
controlled trial. Acta Obstet Gynecol Scand. 2019;00:1‐8.
https​://doi.org/10.1111/aogs.13712​