European Journal of Obstetrics & Gynecology and Reproductive Biology 204 (2016) 78–82

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European Journal of Obstetrics & Gynecology and

Reproductive Biology
journal homepage: www.elsevier.com/locate/ejogrb

Double-balloon catheter and sequential oral misoprostol versus oral

misoprostol alone for induction of labour at term: a retrospective
cohort study
Sven Kehla,* , Christel Weissb , Ulf Dammera , Jutta Heimricha , Matthias W. Beckmanna ,
Florian Faschingbauera , Marc Sütterlinc
a
Department of Obstetrics and Gynaecology, Erlangen University Hospital, Germany
b
Department of Medical Statistics and Biomathematics, University Medical Centre Mannheim, Heidelberg University, Germany
c
Department of Obstetrics and Gynaecology, University Medical Centre Mannheim, Heidelberg University, Germany

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 efficacy of induction of labour using a double-balloon catheter and, if necessary,
Received 18 April 2016 sequential oral misoprostol without delay after removal of the catheter, in comparison with oral
Received in revised form 30 June 2016 misoprostol alone.
Accepted 26 July 2016
Study design: This retrospective cohort study included women undergoing induction of labour with oral
misoprostol or double-balloon catheter with sequential oral misoprostol in singleton pregnancies at
Keywords: term. The catheter was placed in the evening and removed when there was no onset of labour within 12 h.
Induction of labour
Then oral misoprostol was started within 3 h. Primary outcome measure was the caesarean section rate.
Double-balloon catheter
Misoprostol
Results: There were 13,082 deliveries during the study period with 3466 labour inductions out of which
Cervical ripening 1032 were eligible and analysed. The caesarean section rate was significantly lower in the double-balloon
Cervical ripening balloon catheter group (26.1% vs. 17.3, p = 0.021). Furthermore, in the combination group, the induction-to-
Sequential use delivery interval was shorter (median values 1144 vs. 1365 min, p = 0.001) and there were more deliveries
within 24 h (51.9 vs. 64.7%, p = 0.003) and 48 h (87.4 vs. 95.8%, p = 0.002). When stratifying for parity, there
were less caesarean sections in the combination group (37.2% vs. 24.2%, p = 0.015) in nulliparous women,
too. In both, nulliparous and parous women, the induction-to-delivery interval was shorter (1742 vs.
1400 min, 0.005; 1020 vs. 912 min, p = 0.018). Especially in parous women, the rates of delivery within
24 h (62.6% vs. 79.0%, p = 0.007) and 48 h (88.6% vs. 99.0%, p = 0.007) were higher in the combination
group.
Conclusion: Double-balloon catheter and sequential oral misoprostol without long delay in absent onset
of labour after removal of the catheter resulted in less caesarean section and shorter induction-to-
delivery interval in comparison with oral misoprostol alone.
ã 2016 Elsevier Ireland Ltd. All rights reserved.

Introduction devices is as effective as prostaglandins [3–5] and well accepted by

Induction of labour, a common obstetric procedure, is nowadays
being used more widely than ever before [1].
Mechanical and pharmacological methods are available to
promote cervical ripening and the onset of labour. Despite
mechanical methods have been replaced by pharmacological
methods, single and double-balloon catheters have been used
increasingly in the last years [2]. Labour induction with these
* Corresponding author at: Department of Obstetrics and Gynaecology, Erlangen
University Hospital, Universitätsstr. 21-23, 91054 Erlangen, Germany.
Fax: +49 9131 8533468.
E-mail address: sven.kehl@gmail.com (S. Kehl).
the women [6,7].
Modes of action involved in the mechanical and pharmacologi-
cal methods for cervical ripening differ. Investigations evaluating
the effect of a combination of the two practices have shown that
the simultaneous use is beneficial [3,8–10].
When balloon catheters are used for cervical ripening, there is
an onset of labour in 23.5–33% [11,12]. So, further agents are
necessary to achieve labour in most cases. Oxytocin was given in
most previous trials which explains its higher need [3–5]. Some
previous investigations demonstrated good results with sequential
prostaglandins [9].
In a recent publication, we could not find a relevant difference
between oral misoprostol and the sequential use of a double-balloon

http://dx.doi.org/10.1016/j.ejogrb.2016.07.507
0301-2115/ã 2016 Elsevier Ireland Ltd. All rights reserved.
 S. Kehl et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 204 (2016) 78–82
catheter and oral misoprostol [12]. However, in that trial, the balloon
catheter was inserted in the morning, removed after 12 h, and oral
misoprostol given the next morning. It could be demonstrated that
timing of application of balloon catheter is important. Balloon
catheter placed in the evening resulted in a shorter induction to
delivery interval for instance [13].
The aim of this study was therefore to evaluate the efficacy of
induction of labour using a double-balloon catheter and, if
necessary, sequential oral misoprostol without delay after removal
of the catheter, in comparison with oral misoprostol alone.
Patients and methods
This historical cohort study was undertaken in two university
hospitals, Erlangen and Mannheim (2010–2014), in Germany.
Labour inductions with oral misoprostol or double-balloon
catheter with sequential oral misoprostol in singleton pregnancies
at term (259 days of gestation) were included. The double-
balloon catheter (Cook Medical, Cervical Ripening Balloon; Cook
OB/GYN, Bloomington, Indiana, USA) was placed in the evening and
removed when there was no onset of labour within 12 h. Oral
misoprostol was started within 3 h after removal of the balloon
catheter. Women were excluded if the sequential use of double-
balloon catheter and oral misoprostol was different from the
described protocol. Further exclusion criteria were breech
presentation, favourable cervix (Bishop score >6), previous
caesarean section, premature rupture of the membranes, struc-
tural or chromosomal fetal malformation, intrauterine fetal death,
placenta praevia, or any other contraindication to vaginal delivery.
Gestational age was assessed from the menstrual history and
confirmed by measurement of fetal crown–rump length at a first-
trimester scan. The Bishop score was assessed before labour
induction.
The double-balloon catheter was inserted in accordance with
the manufacturer’s instructions in the evening. The balloons
situated on each side of the cervix were filled with up to 80 ml of
saline each. The external end of the mechanical device was taped
without traction to the woman’s thigh. As reported before, the
balloon catheter was removed in cases in which it did not fall out
spontaneously within 12 h. Reasons for removing the catheter
included the request by the woman but not rupture of the
membranes. If labour did not start after mechanical ripening, the
women received misoprostol orally within 3 h after removal.
Initially, the dosages were 50 mg with repeat doses 4 and 8 h later
if the first stage of labour had still not yet begun. A dosage of
100 mg was given up to three times if necessary, 24 h after
the start of misoprostol administration. Forty-eight hours
following the start of oral misoprostol, misoprostol (100 mg)
was administered vaginally every 4 h up to three times per day.
When labour was induced by misoprostol alone, the misoprostol
regimen described above started from the beginning. Neither
artificial rupture of the membranes nor routine oxytocin
administration were carried out routinely in the two participat-
ing hospitals.
The primary outcome parameter was the caesarean section
rate. Secondary outcome measures were the induction-to-delivery
interval (from placement of the balloon catheter or application of
misoprostol), the rate of vaginal deliveries within 24 and 48 h,
failed labour induction (defined as no vaginal delivery within 72 h)
as well as neonatal outcome parameters (e. g. arterial umbilical
cord pH and base excess [BE], Apgar score after 5 min, postpartum
admission to neonatal care unit).
This was a historical cohort study whereas ethical approval by
the institutional review board was not necessary. When the
women were admitted to the hospitals, they accepted use of their
data for analysis.
79
Total deliveries
n=13.082
Labour inducons
n=3.466
Assessed for eligibility
n= 1.032
Oral Misoprostol Double Balloon Catheter-
n=830 Oral Misoprostol
n=202
Fig. 1. Trial profile.
Student’s t-test and the Mann–Whitney U test were used to
compare two groups of continuous normally and non-normally
distributed variables, respectively. The Chi2 test or Fisher’s exact
test has been performed to analyse proportions. For these simple
tests a significance level of 5% was chosen. Furthermore, we
performed multiple logistic regression analysis in order to analyse
several variables (i.e. BMI, height and group) on a binary outcome
simultaneously to adjust for possible confounders. A multiple
linear regression analysis has been done to investigate women’s
BMI, height and the factor “treatment group” on the quantitative
outcome “induction-to-delivery interval”. For these multiple tests,
a significance level of 10% has been chosen. All statistical
calculations have been done with SAS software, release 9.3.
Results
In total, 13,082 women delivered at the participating hospitals
during the study period and labour was induced in 3466 (26.5%).
There were 1032 cases eligible for analysis (Fig. 1). Labour
induction was undertaken in 830 women with oral misoprostol
alone and in 202 cervical ripening was started with a double-
balloon catheter and continued with oral misoprostol in absent
onset of labour after removal of the balloon catheter.
The baseline demographics and pregnancy characteristics were
similar across both groups (Table 1). The women in the misoprostol
group were somewhat younger (29.8  5.6 vs. 30.8  5.4 years,
p = 0.049), smaller (166.3  6.6 vs. 167.8  6.9 cm, p = 0.004) and
less overweight (BMI 28.6  5.9 vs. 27.2  6.3, p = 0.004).
The indications for labour induction are given in Table 2. There
were more inductions for fetal growth restriction, placental
insufficiency or abnormal Doppler ultrasound in the double-balloon
catheter group (3.3% vs. 8.0%, p = 0.003). The other indications were
not significantly different between the two groups.
The pooled outcome parameters are demonstrated in Table 3.
The caesarean section rate, the primary outcome measure, was
significantly lower in the double-balloon catheter group (26.1 vs.
17.3%, p = 0.021). In the combination group, the induction-to-
delivery interval was shorter (median values 1365 [205–9001] vs.
1144 [152–7036] min, p = 0.001) and there were more women that
delivered their baby within 24 h (51.9% vs. 64.7%, p = 0.003) and
48 h (87.4% vs. 95.8%, p = 0.002).
The total median amount of misoprostol used was 150 mg in
both groups, but with a wider range in the oral misoprostol group
80 S. Kehl et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 204 (2016) 78–82

Table 1
Baseline demographics and pregnancy characteristics. Quantitative variables are presented by mean  standard deviation; for ordinal scaled parameters median and range
are given. For categorial factors, absolute and relative frequencies have been assessed. N = sample sizes of the relevant subgroups.

Characteristics Misoprostol (n = 830) Balloon catheter-misoprostol (n = 202) p value

Age (years) 29.8  5.6 30.8  5.4 0.049
Maternal height (cm) 166.3  6.6 167.8  6.9 0.004
Maternal weight (kg) 82.1  17.0 80.6  18.3 0.360
Body mass index 28.6  5.9 27.2  6.3 0.004
Pregnancy 2 (1–14) 2 (1–6) 0.437
Parity 0 (0–8) 0 (0–4) 0.934
Gestational age (days) 282.9  7.4 282.8  8.5 0.878
Birth weight (grams) 3484  472 3465  522 0.323
Bishop score 2 (0–6) 2 (0–6) 0.628

p < 0.05 was considered significant.

Table 2
Indication for labour induction.

Indications Misoprostol Balloon catheter-misoprostol p value

Pregnancy at or beyond 41 weeks 413 101 0.873
(50.1%) (50.8%)
Gestational diabetes 88 22 0.878
(10.7%) (11.1%)
On request 83 18 0.653
(10.1%) (9.0%)
Anhydramnios, oligohydramnios 50 13 0.807
(6.1%) (6.5%)
Suspected fetal macrosomia 33 4 0.209
(4.0%) (2.0%)
Reduced fetal movements 20 2 0.283
(2.4%) (1.0%)
Fetal growth restriction; placental insufficiency; abnormal doppler 27 16 0.003
(3.3%) (8.0%)
Preeclampsia, hypertensive disorders 49 12 0.964
(5.9%) (6.0%)
Abnormal CTG 27 5 0.578
(3.3%) (2.5%)
Intrahepatic cholestasis of pregnancy 12 3 1.000
(1.5%) (1.0%)
Other 22 3 0.449
(2.7%) (1.0%)

CTG: cardiotocography.
Data are presented as absolute and relative frequencies. p < 0.05 was considered significant.

(150 [50–1350] vs. 150 [50–700], p = 0.03). Epidural anaesthesia
was used more often in the combination group (34.1% vs. 42.8%,
p = 0.022). Using logistic regression analysis we found that the
caesaren section rate also depends on women’s BMI (p = 0.031) and
height (p = 0.001). However, the influence of the “treatment group”
remains significant (p = 0.031) in this multiple analysis indicating
that caesarean section rate actually depends on the method of
labour induction. The induction-to-delivery interval was shorter in
the double-balloon catheter group (p < 0.001). This difference
remained significant in the multiple regression analysis (treatment
group: p = 0.001, BMI p = 0.019 and height p = 0.177).
In Table 4, the outcome parameters were depicted according to
the parity. There were less caesarean sections in the double-
balloon catheter group (37.2% vs. 24.2%, p = 0.015) in nulliparous
women. Moreover, the induction-to-delivery interval was shorter
(1884.5  1207.9 vs. 1543.5  1054.2 min, p = 0.015) and there were
found less abnormal CTGs (suspicious or pathological according
FIGO Consensus Guideline) when sequential balloon catheter and
oral misoprostol was used (34.0% vs. 24.2%, p = 0.038). Using
multiple regression analysis the following p values were obtained
for the induction-to-delivery interval: p = 0.089 (treatment group),
p = 0.001 (BMI) and p = 0.472 (height). However, the rate of epidural
anaesthesia was higher (45.8% vs. 59.2%, p = 0.008). There was a
tendency for more women who delivered within 24 and 48 h in the
combination group (41.8 vs. 52.7% and 64.6 vs. 93.4%, respectively);
but these differences where not significant (p = 0.063 and p = 0.07,
respectively). A multiple logistic regression analysis revealed
p = 0.047 (treatment group), p = 0.001 (BMI) and p = 0.001 (height).
This confirms the treatment influence on the binary outcome
“caesarean section”.
In parous women, the caesarean section rate was not different
(9.1% vs. 7.0%, p = 0.782). But the induction-to-delivery interval was
shorter (1449.0  1128.0 vs. 1022.3  601.6 min, p = 0.002) and the
rates of deliveries within 24 h (62.6% vs. 79.0%, p = 0.007) and 48 h
(88.6% vs. 99.0%, p = 0.007) were higher in the combination group.
The difference regarding the induction-to-delivery interval
remained significant with a multiple regression analysis (treat-
ment group p = 0.001, BMI p = 0.419, height p = 0.017). The other
outcome parameters were not different between the two groups.
All five cases of chorioamnionitis were observed in the oral
misoprostol group in nulliparous women. There was no increased
risk when using balloon catheter and oral misoprostol sequentially.
Discussion
The indications for induction of labour have broadened in
recent years. So, obstetricians are increasingly faced with
unfavourable cervical conditions. New strategies are necessary
for successful labour induction since current methods often lead
to failed labour inductions. Combination of mechanical and
 S. Kehl et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 204 (2016) 78–82 81

Table 3
Outcome parameters.

Outcome parameters Misoprostol (n = 830) Balloon catheter-misoprostol (n = 202) p value

Mode of delivery (n, %)
Normal vaginal delivery 523 (63.0%) 147 (72.8%) 0.021
Surgical vaginal delivery 90 (10.8%) 20 (9.9%)
Caesarean section 217 (26.1%) 35 (17.3%)
Induction-delivery-interval (min)a 1673.5  11898.0 1306.3  193.1 <0.001
Vaginal delivery within 24 h (n, %)b 318 (51.9%) 108 (64.7%) 0.003
Vaginal delivery within 48 h (n, %)b 536 (87.4%) 160 (95.8%) 0.002
Failed induction of labour = no vaginal delivery within 72 h (n, %)b 22 (3.6%) 2 (1.2%) 0.113
No. of applications of misoprostol (median, range) 3 (1–12) 3 (1–9) 0.094
Total amount of misoprostol used (mg; median, range) 150 150 0.030
(50–1350) (50–700)
Arterial pH < 7.05 (n, %) 7 (0.8%) 0 0.357
Arterial pH < 7.10 (n, %) 23 (2.8%) 1 (0.5%) 0.065
BE 3.9 ( 16 – +4.5) 3.8 ( 14.9 – +1.2) 0.397
BE < –12 (n, %) 13 (1.6%) 2 (1.0%) 0.748
Apgar score at 5 min 10 (4–10) 10 (6–10) 0.011
Apgar score at 5 min < 7 (n, %) 5 (0.6%) 2 (1.0%) 0.628
BE < 12 and Apgar score at 5 min <7 (n, %) 1 (0.1%) 0 1.000
Abnormal carditocography (n, %) 209 (25.2%) 38 (18.8%) 0.057
Abnormal fetal blood analysis (n, %) 5 (0.6%) 2 (1.0%) 0.628
Epidural anaesthesia (n, %) 280 (34.1%) 86 (42.8%) 0.022
Oxytocin (n, %) 349 (42.7%) 99 (49.5%) 0.083
Meconium-stained amniotic liquor (n, %) 131 (15.8) 34 (16.8%) 0.674
Chorioamnionitis 5 (0.6%) 0 0.59
Postpartum transfer to neonatal care unit (n, %) 105 (12.7%) 28 (13.9%) 0.382

Quantitative variables are presented by mean  standard deviation; for ordinal scaled parameters median and range are given.
BE, base excess.
a
Caesarean sections and failed induction of labour are excluded.
b
Caesarean sections are excluded.

Table 4
Outcome parameters in nulliparous and parous women.

Outcome parameters Nulliparous (no previous delivery) Parous (previous delivery)

Misoprostol Balloon p Misoprostol Balloon p value

(n = 503) catheter-misoprostol value (n = 327) catheter-misoprostol
(n = 120) (n = 82)
Mode of delivery (n, %)
Normal vaginal delivery 237 (47.1%) 73 (60.8%) 0.015 286 (87.5%) 74 (90%) 0.782
Surgical vaginal delivery 79 (15.7%) 18 (15.0%) 11 (3.4%) 2 (2%)
Caesarean section 187 (37.2%) 29 (24.2%) 30 (9.1%) 6 (7%)
Induction-delivery-interval (min)a 1884.5  1207.9 1543.5  1054.2 0.015 1449.0  1128.0 1022.3  601.6 0.0016
Vaginal delivery within 24 h (n, %)b 132 (41.8%) 48 (52.7%) 0.063 186 (62.6%) 60 (79%) 0.007
Vaginal delivery within 48 h (n, %)b 273 (64.6%) 85 (93.4%) 0.070 286 (88.6%) 75 (99%) 0.007
Failed induction of labour (n, %)b 14 (4.4%) 2 (2.2%) 0.541 8 (2.7%) 0 0.368
No. of applications of misoprostol (median, range) 3 (1–12) 3 (1–9) 0.410 3 (1–12) 2 (1–6) 0.128
Total amount of misoprostol used (mg; median, 150 (50– 1150) 150 (50–700) 0.255 150 (50–1350) 100 (50–450) 0.052
range)
Arterial pH 7.3 (6.9–7.5) 7.3 (7.1–7.4) 0.014 7.3 (7.1– 7.5) 7.3 (7.1– 7.5) 0.064
Arterial pH < 7.05 (n, %) 5 (1.0%) 0 0.589 2 (0.6%) 0 1.000
Arterial pH < 7.10 (n, %) 18 (3.6%) 1 (0.8%) 0.145 5 (1.5%) 0 0.588
BE 3.9 ( 16 – +3.3) 4.35 ( 12 – +0.5) 0.881 3.6 ( 12.8 – +4.5) 2.9 ( 14.9 – 1.2) 0.169
BE < 12 (n, %) 9 (1.8%) 0 0.218 4 (1.2%) 2 (2%) 0.347
Apgar score at 5 min 10 (4–10) 10 (6–10) 0.099 10 (7–10) 10 (7–10) 0.045
Apgar score at 5 min <7 (n, %) 5 (1.0%) 2 (1.7%) 0.624 0 0 n.a.
BE < –12 and Apgar score at 5 min <7 (n, %) 1 (0.2%) 0 1.000 0 0 n.a.
Abnormal cardiotocography (n, %) 171 (34.0%) 29 (24.2%) 0.038 38 (11.6%) 9 (11%) 0.87
Abnormal fetal blood analysis (n, %) 5 (1.0%) 2 (1.7%) 0.625 0 0 n.a.
Epidural anaesthesia (n, %) 227 (45.8%) 71 (59.2%) 0.008 53 (16.4%) 15 (19%) 0.642
Oxytocin (n, %) 284 (57.6%) 81 (67.5%) 0.048 65 (19.9%) 18 (22%) 0.629
Meconium-stained amniotic liquor (n, %) 97 (19.3%) 23 (19.2%) 0.518 34 (10.4%) 11 (13.4%) 0.756
Chorioamnionitis 5 (1.0%) 0 0.589 0 0 n.a.
Postpartum transfer to neonatal care unit (n, %) 72 (14.3%) 19 (15.8%) 0.576 33 (10.1%) 7 (8.5%) 0.432

Quantitative variables are presented by mean  standard deviation; for ordinal scaled parameters median and range are given. p < 0.05 was considered significant.
a
Caesarean sections and failed induction of labour are excluded.
b
Caesarean sections are excluded, n.a. = not applicable.
82 S. Kehl et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 204 (2016) 78–82
pharmacological methods for inducing labour seems promising
therefore this study examined the sequential use of a double-
balloon catheter and oral misoprostol. When there was no onset of
labour after application of the mechanical device, oral misoprostol
was given afterwards without long delay.
This regimen was compared with oral misoprostol alone and
resulted in less caesarean sections. Moreover, the induction-to-
delivery interval was shorter and there were more deliveries
within 24 and 48 h. The lower caesarean section rate could only be
seen in the nulliparous women. In nulliparous as well as in parous
women, the induction-to-delivery interval was shorter in the
combination group. There were more childbirths within 24 and
48 h in parous women, too.
One strength of this trial is the high number of included cases.
However, it was a multicentre historical cohort study, not a
randomized controlled trial. In a recent multicentre randomized
controlled trial, sequential use of a double-balloon catheter and
oral misoprostol did not show any benefit [12]. In that trial,
however, oral misoprostol was given the second day, more than
12 h after removal of the balloon catheter. There was no difference
in the caesarean section rate, but the number of applications of
misoprostol and the total amount of misoprostol was lower in the
combination group. In the present trial, the strategy of sequential
use proved to be superior.
A recent investigation demonstrated that placement of the
balloon catheter in the evening and starting oral misoprostol
shortly after removal 12 h later in absent of labour was better than
application in the morning [13]. Since there was no delay, the
induction-to-delivery interval was shorter, the rate of childbirth
within 48 h was higher and there were less failed inductions. In this
trial, oral misoprostol was given within three hours after removal
of the balloon catheter, and there were better induction-to-
delivery intervals and rates within 24 and 48 h, too.
Ande et al. compared sequential use of single-balloon catheter
and vaginal misoprostol with vaginal misoprostol alone [9]. The
sequential use was more effective than misoprostol alone with less
caesarean sections (20% vs. 40%) and a shorter induction to delivery
interval (514  175 vs. 627  268, p = 0.014) [9]. These results are
similar with the findings of the present trial.
Most of the published investigations with balloon catheters for
induction of labour reported an increased need for oxytocin in
comparison with prostaglandins [3–5]. This is due to the different
strategies. Using balloon catheters led to onset of labour in almost
one in three to four cases [3–5,9,11,12]. Further methods for
inducing labour are necessary and most obstetricians used
oxytocin afterwards. We continued with oral misoprostol when
the cervix was still unfavourable. There was no routine adminis-
tration of oxytocin and therefore the rate of oxytocin application
was not different between the groups. This could also be found in
previous trials [9,12,13].
It was also emphasized that using balloon devices increases the
likelihood of epidural anaesthesia [3–5,11]. But this could not be
demonstrated in recent trials [8,9,13]. There were more epidural
anaesthesia in nulliparous women, but not in parous women in this
investigation.
Both, balloon catheters and oral misoprostol for induction of
labour, are well-accepted methods by the women [6,7,14]. This is
important since in addition to clinical outcomes, safety profile, and
cost-effectiveness, women’s expectations also need to be taken
into account. Placement of the balloon catheter in the evening
should be preferred since the sleep of the women is not interrupted
when there is no onset of labour. Labour induction with balloon
catheters is very safe and therefore monitoring during night not
necessary. Women prefer when they will not be disturbed at night
[15].
There were no serious complications in this trial. The rate of
abnormal cardiotocography was even higher in the oral misopros-
tol group in nulliparous women. But neither birth asphyxia nor
increased rates of infection were seen in one of the groups. Little
risk for hyperstimulation and infection could also be demonstrated
in further trials [3–5,9,12,13]. So, induction of labour through night
without continuous monitoring seems to be unproblematic in this
context.
There are not enough well-conducted studies investigating the
sequential use of balloon catheter and oral misoprostol for
evidence-based recommendation. So, further randomized con-
trolled trials that consider the timing of placement of balloon
catheter and the continuation with oral misoprostol shortly after
removal of the mechanical device should be undertaken.
Conclusion
Induction of labour with balloon catheter and sequential oral
misoprostol reduced the caesarean section rate in comparison with
oral misoprostol alone. Moreover, a shorter induction-to-delivery
interval and more deliveries within 24 and 48 h could be found in
the combination group.
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