DOI: 10.1111/1471-0528.

15047 Systematic review

www.bjog.org

Safety of the balloon catheter for cervical

ripening in outpatient care: complications during
the period from insertion to expulsion of a
balloon catheter in the process of labour
induction: a systematic review
M Diederen,a,* JSM Gommers,a,* C Wilkinson,b D Turnbull,c BWJ Mold
a
Faculty of Health, Medicine and Life Sciences, Maastricht University, ER Maastricht, the Netherlands b Department of Obstetrics and
Gynaecology, Women’s and Children’s Hospital, North Adelaide, SA, Australia c School of Psychology, The University of Adelaide, North
Terrace, Adelaide, SA, Australia d The Robinson Research Institute, School of Paediatrics and Reproductive Health, The University of
Adelaide, North Adelaide, SA, Australia
Correspondence: M Diederen, Faculty of Health, Medicine and Life Sciences, Maastricht University, Universiteitssingel 60, 6229 ER Maastricht,
the Netherlands. Email diederen.milou@gmail.com

Accepted 17 November 2017. Published Online 10 January 2018.

Background It has been suggested that cervical ripening with a
balloon catheter for labour induction can be done in an
outpatient setting in low-risk pregnancies. Introduction of such an
approach needs to be accompanied with monitoring of potential
complications. Therefore the existence and frequency of any
associated adverse event during cervical ripening needs to be
established.
Objective To assess the complication rate during cervical ripening
with balloon induction.
Search strategy We searched Embase, Medline, Cochrane
Collaboration and CINAHL using keywords ‘induction of labour’,
‘cervical ripening’, ‘balloon catheter’, ‘Foley balloon’, ‘transcervical
balloon’.
Selection criteria We included randomized controlled trials and
cohort studies containing original data on fetal and maternal
morbidity in pregnant women during cervical ripening with a
balloon catheter. Only articles for which authors were able to give
data for this exact time frame were included.
Data collection and analysis Two reviewers assessed independently
the eligibility of included studies, extracted data and performed a
quality assessment. A meta-analysis was performed to calculate the
estimated prevalence of the adverse events.
Main results In total 26 studies were included reporting on 8292
women. The estimated prevalence of the analysed adverse events
in the random effects model was between 0.0 and 0.26%, of which
‘pain/discomfort’ had the highest prevalence.
Conclusion This study suggests the risk of adverse events during
the period between insertion and expulsion of a balloon catheter
in cervical ripening to be low. These data facilitate further
evaluation and implementation of this procedure in an outpatient
setting for low-risk pregnancies.
Keywords Balloon catheter, cervical ripening, complications,
induction of labour, outpatient care, safety, systematic review.
Tweetable abstract Balloon catheter for cervical ripening appears
to be safe enough to evaluate its use in the outpatient setting.

Please cite this paper as: Diederen M, Gommers JSM, Wilkinson C, Turnbull D, Mol BWJ. Safety of the balloon catheter for cervical ripening in outpatient
care: complications during the period from insertion to expulsion of a balloon catheter in the process of labour induction: a systematic review. BJOG 2018;
125:1086–1095.

Approximately 25% of all term pregnancies are induced.1

Introduction
Induction of labour is one of the most commonly per-
formed obstetric interventions in well-resourced countries.
*Both authors contributed equally to this review.
Labour induction results in better clinical outcomes for
both women and their babies if the associated maternal/
fetal risks are lower than the risks of continuation of the
pregnancy.2 Cervical ripening is part of induction of labour
which aims to relax and soften the cervix prior to onset of

1086 ª 2017 Royal College of Obstetricians and Gynaecologists


uterine contractions. Worldwide the transcervical balloon
catheter is used as a mechanical method for cervical ripen-
ing. It stretches the cervix and stimulates the release of
local decidual and cervical prostaglandins. Two previous
reviews show that the balloon catheter is an effective
method for cervical ripening as compared with pharmaco-
logic induction with prostaglandins.3,4 The concept of out-
patient induction of labour is an attractive alternative to
inpatient care both economically and on the grounds of
patient satisfaction.5,6 The balloon catheter has lower rates
of excessive uterine activity in comparison with prostaglan-
dins, which could make it a more suitable and attractive
induction method for use in an outpatient setting.7–9 Out-
patient management for cervical ripening in low-risk preg-
nant women has therefore been proposed.10 Knowledge on
the safety of such a policy is crucial, especially the occur-
rence of adverse events between the moment of insertion
and expulsion of the balloon catheter, as women in this
period are not under strict hospital monitoring. The aim of
this systematic review is to assess the patient safety of
labour induction with a transcervical balloon catheter
between introduction and expulsion of the balloon, and to
thereby determine the risk of adverse events during the
period women would go home in an outpatient setting.
Methods
Data sources
We searched Embase, Medline, Cochrane Collaboration
and the Cumulative Index to Nursing and Allied Health
Literature (CINAHL) up to 10 October 2016 for ran-
domised controlled trials (RCTs) and cohort studies on
cervical ripening or labour induction with a balloon cathe-
ter. Search terms used were ‘induction of labour’, ‘cervical
ripening’, ‘balloon catheter’, ‘Foley balloon’ and ‘transcervi-
cal balloon’. These terms were developed in collaboration
with a medical librarian. No restrictions in relation to lan-
guage or date were applied. Details of the search strategy
are documented in Appendix S1.
Inclusion criteria
We only considered RCTs and cohort studies with more than
400 participants that contained original data on the occur-
rence of adverse events during labour induction by a tran-
scervical balloon catheter in pregnant women with
unfavourable cervices and live fetuses in vertex position. We
considered studies carried out in the inpatient hospital set-
ting and in the outpatient setting. Both high- and low-risk
pregnant women, referred to secondary care, receiving inter-
ventions with a balloon catheter regardless of sort (single ver-
sus double) or volume were included. Articles that explicitly
reported on the absence of adverse events in all participants
were also included. Studies were excluded if labour was
ª 2017 Royal College of Obstetricians and Gynaecologists
Safety balloon catheters for outpatient cervical ripening
induced for pregnancy termination or intrauterine fetal
death. Articles that combined use of the balloon catheter
with concurrent administration of other pharmacological
and mechanical methods or used the balloon catheter as a
second option after first induction failed were also excluded.
Studies that administered oxytocin or performed artificial
rupture of membranes (ARM) for augmentation of labour
after spontaneous expulsion or removal of the balloon cathe-
ter were not excluded. To be selected, the study had to record
at least one of the adverse events mentioned in Table 2 dur-
ing the in situ period of the balloon catheter. If studies met
the inclusion and exclusion criteria, the original authors were
contacted for specific information on the occurrence/record-
ing of adverse events between balloon insertion and expul-
sion. An article was excluded if adverse events were not
recorded for all study participants or if they did not occur in
this exact time frame. If authors were not traceable, the
article was also excluded.
Study selection
Two reviewers (M.D. and J.G.) independently reviewed the
titles and abstracts of all potential studies, followed by full-
text selection. Disagreement was resolved by discussion and
consensus; if needed, the opinion of a third author
(B.W.M.) was decisive.
Data abstraction and quality assessment
M.D. and J.G. emailed individual authors to request speci-
fic information on the time frame and course of the
adverse events reported in tables, graphs, and text, as well
as the indication for induction. If data on recording/occur-
rence of complications (see Table 2) during the in situ per-
iod of the balloon catheter were already provided in the
manuscript, this information was directly extracted from
the article. There were no discrepancies between the
author’s response and the published data. The included
data were extracted by the intention-to treat principle using
a data extraction file based on the Cochrane process.11 The
quality of eligible studies was evaluated independently by
the two reviewers according to the standardised critical
appraisal instruments from the Joanna Briggs Institute
Meta-Analysis of Statistics Assessment and Review
Instrument (JBI-MAStARI).12
Data analysis
Data on maternal and fetal morbidity during cervical ripen-
ing were pooled and individual cases of complications were
discussed. The proportion of complication rate was pooled
using the rme function (DerSimonian Laird estimator)
within ‘metafor’ package in R (version 3.3.1) and reported
with 95% confidence intervals (CI). We analysed our data
with double arcsine transformation (Freeman-Tukey)
because of the expectation that most studies will report a low
1087
 Diederen et al.
prevalence. To measure the amount of between-study varia-
tion that is due to systematic heterogeneity rather than
chance, the heterogeneity was evaluated by calculating the I2
metric. We used the PRISMA guidelines and checklist (2009)
for conducting this systematic review.13
Results
Study selection and characteristics
After duplicate selection, a total of 585 studies were
screened for eligibility by title and abstract, of which 97
studies were eligible for full-text assessment (Figure S1). In
total, 36 articles were excluded because: contact details of
authors were not traceable (n = 18), other pharmacologic
methods were used concurrently (n = 4), there was induc-
tion for intrauterine fetal death (n = 5), cohort size <400
(n = 2), no original data were used (n = 3) or other rea-
sons (n = 4). Appendix S2 provides a list of excluded arti-
cles. Overall, the methodologic quality of the studies was
good and therefore no studies were excluded after method-
ologic quality assessment. We emailed 61 authors with a
request for specific information on the occurrence of
adverse events between balloon catheter insertion and
expulsion. We got 27 responses, two of which indicated
that they were not able to supply information. The other
34 authors did not respond, even after sending reminders
and resending the mail to co-authors. One RCT was
included after study selection to update the results of the
review. In total, 26 studies (8292 women) were identified
as eligible for inclusion, of which 21 were RCTs, two
prospective, and three retrospective cohort studies. Two
studies were carried out (partially) in an outpatient setting
and 23 were conducted in an inpatient hospital setting. A
total of 22 studies reported on a single balloon catheter,
one study on a double balloon catheter, two studies com-
pared both catheter types, and this information was
unknown for one study. Balloon volumes ranged from 30
to 80 ml. Other study characteristics are shown in Table 1.
Adverse events during cervical ripening with a
balloon catheter
Table 2 shows the adverse events that occurred during cer-
vical ripening between insertion and expulsion of the bal-
loon catheter. Per adverse event, we only included data of
studies that recorded this adverse event for all study partic-
ipants. Therefore the total number of participants per
adverse event differs (Table 2). Table S1 shows which arti-
cles were included in the analyses per adverse event. The
following adverse events were reported: pain/discomfort;
unintended amniotomy; vaginal bleeding; balloon displace-
ment; non-reassuring fetal heart rate; allergic reaction;
voiding problems; balloon rupture; uterine hyperstimula-
tion; uterine hypertonus; decreased fetal movements and
1088
malpresentation. Figure 1 shows the proportion of compli-
cation rates using random effect models for adverse events
for which the occurrence rates are high enough to be
pooled reliably. As the occurrence rate was too low for the
other adverse events, we were not able to pool the data
reliably. The heterogeneity across the studies was substan-
tial (I2 varied between 48.63 and 85.42%).
Indication for induction
The reason for induction, listed per study and per adverse
event, is displayed in Table S2a and S2b. The overall reason
for induction was most often post-term pregnancy. The
reason for induction in women who had an adverse event
during cervical ripening was also most often post-term
pregnancy (Table S2a and S2b).
In the following, both adverse events that were reliably
pooled as well as the events that were not pooled are dis-
cussed. A more detailed discussion of the data of the
adverse events that have been pooled can be found in
Appendix S3.
Pain/discomfort
There were 17 studies (5754 women) that reported on
pain/discomfort. A total of six studies reported on the
occurrence in 31 women. The estimated prevalence of
pain/discomfort across the studies in the random effects
model was 0.26% (95% CI 0.00–1.01%). In some women
the catheter had to be removed,14–16 but mostly induction
of labour was continued normally.10,17
Unintended amniotomy
There were 12 studies (2989 women) that reported on
unintended amniotomy. Two studies reported on the
occurrence in 19 women. The estimated prevalence of
unintended amniotomy across the studies in the random
effects model was 0.04% (95% CI 0.00–0.69%). In these
women either a different method of induction was per-
formed 18 or induction was continued with the balloon
catheter and prophylactic antibiotics were started.19 No
infections due to the unintended amniotomy occurred.
Vaginal bleeding
There were 18 studies (6566 women) that reported on vagi-
nal bleeding. A total of 10 studies reported on the occur-
rence in 18 women. The estimated prevalence of vaginal
bleeding across the studies in the random effects model
was 0.07% (95% CI 0.00–0.33%). In some women, the
catheter had to be removed and ripening had to be pur-
sued with a different method.20 In other women, the bleed-
ing resolved spontaneously and induction with the catheter
was continued.10,21 In three cases a caesarean section (CS)
was performed due to severe bleeding and in one woman
due to a marginal placenta praevia.18,19,22 Two of these
ª 2017 Royal College of Obstetricians and Gynaecologists
 Safety balloon catheters for outpatient cervical ripening

Table 1. Study characteristics

Study Sample size Study design Sort catheter Volume (ml) Tension applied? Previous caesarean
section (%)

Afolabi et al.32 50 RCT SBC 30 Yes 0

Battarbee et al.33 546 Retrospective cohort SBC 80 Yes 0
Chavakula et al.34 53 RCT SBC 30 No 0
De Oliveira e Oliveira et al.17 80 RCT SBC 30 Yes 0
Gu et al.23 504 RCT SBC 30 (n = 252) Yes 0
80 (n = 252)
Henry et al.9 Outpatient 50 RCT SBC 30 Yes 0
Huisman et al.22 1014 Prospective cohort n/a n/a n/a 100
Jozwiak et al.15 411 RCT SBC 30 No 0
Jozwiak et al.7 107 RCT SBC 30 No 0
Jozwiak et al.35 54 RCT SBC 30 No 0
Kruit et al.10 Outpatient 185 Prospective cohort SBC 40 to 50 Yes 17
Inpatient 257 18
Kruit et al.36 89 RCT SBC 40 to 50 Yes 0
Kruit et al.19 432 Retrospective cohort SBC 30 to 60 Yes 0
Loekegaard et al.25 264 RCT DBC 80 and 80 n/a Partial
population (n/a)
Manish et al.27 154 RCT SBC 30 (n = 77) n/a 100
80 (n = 77)
Meetei et al.28 30 RCT SBC 30 n/a 100
Mundle et al. 18 300 RCT SBC 30 Yes 0
Ahmad Mohed Faizel et al.26 30 RCT SBC 60 Yes 100
Noor et al.37 44 RCT SBC 50 Yes 0
Pennell et al.8 110 RCT SBC 30 Yes 0
107 DBC 80 and 80 No
Prager et al.14 198 RCT SBC 50 Yes 0
Roudsari et al.38 59 RCT SBC 50 n/a 0
Salim et al.16 145 RCT SBC 60 Yes 0
148 DBC 80 and 80 No
Sciscione et al.24 1905 Retrospective cohort SBC 30 Yes 0
Ten Eikelder et al.20 921 RCT SBC 30 No 0
Ugwu et al.21 45 RCT SBC 30 Yes 0
Total sample size 8292

DBC, double balloon catheter; n/a, information not available; RCT, randomised controlled trial; SBC, single balloon catheter.

neonates had good Apgar scores and information of the
third one was not available to us.
Balloon displacement
There were 10 studies (2397 women) that reported on bal-
loon displacement. Four studies reported on the occurrence
in 12 women. The estimated prevalence of balloon dis-
placement across the studies in the random effect model
was 0.07% (95% CI 0.00–0.62%). In most women, a differ-
ent method of induction was used after displacement of
the balloon catheter. 8,9,20
Non-reassuring fetal heart rate
There were 17 studies (5351 women) that reported on
non-reassuring fetal heart rate after balloon insertion.
Five studies reported 15 cases of non-reassuring fetal
heart rate with an estimated prevalence across the studies
in the random effects model of 0.01% (95% CI 0.00–
0.22). In some women, the induction of labour was
continued normally9 or the balloon catheter was
removed.18,19 In other women a CS was performed.19,23,24
Only in two cases was a neonate born with low Apgar
scores and these neonates were admitted to the NICU for
no longer than 5 days.9,19
Allergic reaction
There were 16 studies (6832 women) that reported on
allergic reaction, of which two studies reported a total of
two allergic reactions.15,20 One woman with a known latex
allergy experienced mild symptoms but there was no

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 Diederen et al.

Table 2. Adverse events during cervical ripening phase time frame with a transcervical balloon catheter

Adverse events No. of studies reporting on Occurrence of AE Reference numbers of studies that report
adverse event (Total sample size) in ripening period on occurrence of AE in ripening period

Pain, discomfort 17 (5754)*, *** 31*** 10,14–17,22

Unintended amniotomy 12 (2989) 19 18,19
Vaginal bleeding 18 (6566)* 18** 7,10,15,17–22,37
Balloon displacement 10 (2397) 12 8,9,20,37
Non-reassuring fetal heart rate 17 (5351) 15 9,18,19,23,24
Allergic reaction 16 (6832) 2 15,20
Voiding problems 10 (3522)* 2 10
Balloon rupture 12 (3222)* 1 10
Uterine hypertonus 14 (3707) 1 7
Uterine hyperstimulation 20 (4812) 1 23
Decreased fetal movements 11 (4318)* 1 10
Malpresentation 16 (6046) 4 24,25,33
Intrapartum infection 15 (5023) 0 –
Placental abruption 16 (6154)* 0 –
Uterine tachysystole 19 (4450) 0 –
Uterine rupture 23 (7916) 0 –
Cord prolapse 21 (6960) 0 –
Fetal death 24 (8189) 0 –
Maternal death 22 (6875) 0 –
Genital laceration 13 (4420) 0 –

AE, adverse event; DBC, double balloon catheter.

*Kruit et al.10: only data for outpatient group on this adverse events.
**de Oliveira e Oliveira et al.17: one women with vaginal bleeding, this woman was excluded from their analysis but included in this review. The
sample size of the intention-to-treat was maintained.
***Salim et al.16: only data for DBC group on this adverse event; one women with discomfort in the DBC group, this woman was excluded from
their analysis but included in this review. The sample size of the intention-to-treat was maintained.

suspicion of anaphylactic shock. After removal, misoprostol
was given and a CS was performed. A neonate was deliv-
ered (Apgar scores 6/9) without NICU admission.20 Infor-
mation about the other woman was not available to us.
Voiding problems
There were 10 studies (3522 women) that reported on
voiding problems. Only one study reported that two
women had to return to the hospital because of difficulties
urinating at home.10 They presented with the Foley catheter
expulsed in the vagina, and after catheter removal they
could urinate normally again. Both women had a Bishop
score of 6 and induction of labour was continued with
amniotomy and oxytocin.
Balloon rupture
There were 12 studies (3222 women) that reported on bal-
loon rupture. Only one study reported one woman with
balloon rupture in the outpatient setting.10 She returned to
the hospital 4 hours after insertion because of balloon rup-
ture and subsequent catheter expulsion. As the Bishop
score was 7, induction of labour was continued with
amniotomy and oxytocin. A healthy neonate was delivered
vaginally.
Abnormal uterine activity
There were 20 studies (4812 women) that reported on uter-
ine hyperstimulation. Only one study reported one woman
with hyperstimulation (more than five uterine contractions
in 10 minutes in a consecutive 30-minute interval), who
did not respond to tocolytic agent and had a CS.
There were 14 studies (3707 women) that reported on
uterine hypertonus. One study reported one woman with
hypertonus after Foley catheter insertion, without CTG
abnormalities.7 The intervention was discontinued and arti-
ficial rupture of the membranes was done the next morn-
ing. Information about the outcome of the neonate was
not available.
Decreased fetal movements
There were 11 studies (4318 women) that reported on
decreased fetal movements, of which one study reported on
the occurrence of one event.10 This woman had a normal
CTG and induction of labour was continued uneventfully

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 Safety balloon catheters for outpatient cervical ripening

Figure 1. Prevalence of adverse events during cervical ripening phase with a transcervical balloon catheter.

ª 2017 Royal College of Obstetricians and Gynaecologists 1091

 Diederen et al.

Figure 1. Continued.

in an inpatient setting with the delivery of a healthy
neonate.
Malpresentation
There were 16 studies (6046 women) that reported on mal-
presentation. A total of three studies reported on the
occurrence in four women. In one case, altered presenta-
tion from vertex to breech was noticed just after the double
balloon catheter fell out the morning after insertion.25 A
healthy neonate was delivered by a CS. One study reported
one case of face presentation during their study period with
a single balloon catheter, after which a CS was performed.24

1092 ª 2017 Royal College of Obstetricians and Gynaecologists


Another study described two cases of non-cephalic presen-
tation which was noticed just after Foley catheter removal.
Prior to insertion of the Foley catheter, an ultrasound con-
firmed a cephalic presentation. Therefore it was assumed
that the rotation occurred during cervical ripening. Both
women delivered healthy neonates via a CS.
Discussion
Main findings
In this study, we reviewed the occurrence of adverse events
during the in situ period of the balloon catheter to assess
the safety for outpatient management of cervical ripening.
Among the 8292 women included, the estimated prevalence
of the analysed adverse events in the random effects model
was between 0.0 and 0.26%. Some adverse events resulted
in a CS, but mostly the induction of labour with the bal-
loon catheter was continued without any concerns. Almost
all the included studies used a single balloon catheter, thus
precluding a statement on the occurrence of adverse events
in the single versus double balloon group. This was also
the case in relation to applying tension or no tension on
the balloon catheter.
Strengths and limitations
As far as we know, this is the first systematic review that
analyses occurrence of adverse events during the in situ
period of the balloon catheter used for cervical ripening as
part of labour induction. We included only RCTs and large
cohort studies to prevent publication bias. We obtained
information by emailing authors for specific information
on their studies, which enabled us to collect data from a
large study population. Therefore our pooled data reflects
the real complication risk in the most robust way possible.
As we analysed a large number of both major and minor
adverse events, we were able to assess the occurrence rate
of a wide spectrum of complications during cervical ripen-
ing which makes our insight into the possible risks as com-
prehensive as possible. These adverse events were selected
because of their clinical importance in the context of out-
patient care and/or because they were commonly reported
in the literature.
This study also has its limitations. We only obtained
data from authors who replied to our request, which made
us dependent on the accuracy of the information provided
by them. Besides this, included studies were heterogeneous
in design, method of intervention, and demographic char-
acteristics. Some women had a previous CS and the vol-
umes of balloon catheters that were used varied between 30
and 80 ml. Unfortunately, there was no standardised set of
outcome measures related to safety while assessing the
included studies. Another limitation is that we did not
record adverse events that occurred during the period
ª 2017 Royal College of Obstetricians and Gynaecologists
Safety balloon catheters for outpatient cervical ripening
between balloon catheter expulsion and re-admission. This
may have led to us missing data and could result in a
higher occurrence rate of adverse events during outpatient
management. Additionally, exclusion of cohort studies
smaller than 400 participants might lead to an overestimate
of the prevalence.
Interpretation
The focus of this review is outpatient care, which has been
proposed for low-risk pregnancies. Notwithstanding, we also
included data on high-risk women in the inpatient setting
who have much higher risks of developing complications.
Therefore the real risk of developing an adverse event during
cervical balloon ripening in low-risk pregnancies will likely
be lower than our results imply. Besides this, high-risk
women with at least one previous CS were included, which
has been associated in previous studies with a higher occur-
rence of uterine rupture or scar dehiscence.26–28 Even though
outpatient cervical ripening would generally be unsuitable
for these high-risk women, the occurrence rate of ‘uterine
rupture/scar dehiscence’ was still zero. In the case of exces-
sive uterine activity, induction of labour with a balloon
catheter is mostly recommended because of low occurrence
rates.7–9 The data in this systematic review showed similar
results with only one case of uterine hyperstimulation and
one case of hypertonus during the in situ period. Further-
more, we found one case of malpresentation, which was
detected immediately after balloon catheter expulsion. This
does not seem to have direct implications for induction in
the outpatient setting, because this adverse event would
probably also have been detected in the hospital setting after
catheter expulsion, as there is not a regular check of the fetal
position with ultrasound during the night in the hospital.
These findings in our review would therefore not have any
direct consequences for outpatient care. Some of the adverse
events such as non-reassuring fetal heart rate and vaginal
bleeding occurred directly after balloon catheter insertion.
These adverse events would therefore be diagnosed in the
clinical setting and the women would not be suitable for out-
patient care. In the case of minor events, women will most
likely have enough time to come to the hospital to resolve
the problem and to continue the intervention. Although the
occurrence of minor events is important to bear in mind, it
does not directly restrain possible future implementation of
outpatient care. Another important adverse event is prolapse
of the umbilical cord, as this can induce fetal hypoxia. The
study of Hasegawa et al.29 concludes that the risk of umbili-
cal cord prolapse was significantly increased during the use
of transcervical balloons for cervical ripening. In contrast to
this, the included studies in this systematic review did not
report on the occurrence of cord prolapse during cervical
ripening. As mentioned before, induction of labour in the
outpatient setting is only suitable for low-risk pregnancies. A
1093
 Diederen et al.
possible risk might be that a pregnancy appears to be
uncomplicated but eventually unrecognised complica-
tions present. These women would be categorised as low-
risk and therefore seem suitable for home induction,
whereas the pregnancy is actually high-risk. Two recent
studies have shown that in apparently uncomplicated
pregnancies, small-for-gestational age occurred in 7.9 and
10.8%. 30,31 These neonates had higher rates of composite
neonatal morbidity and therefore inpatient induction of
labour in women with SGA infants is indicated as more
appropriate. Clinicians should be aware of this possible
risk. That being said, they should bear in mind that all
home-induced women return to the hospital for delivery.
In the case that a seemingly low-risk pregnant woman
presents with unrecognised complications, the actual
labour and delivery will be in the hospital where neonatal
care is available.
Conclusion
Our findings suggest a low-risk of developing an adverse
event in the period between insertion and expulsion.
The findings support the consideration of the implemen-
tation of outpatient cervical ripening with a balloon
catheter in low-risk pregnant women after a thorough
clinical assessment post-insertion. As severe complica-
tions cannot be excluded completely by our study, fur-
ther research, preferably in the form of observational
cohort studies, should be performed to support our
statement on outpatient balloon catheter use in low-risk
pregnancies.
Acknowledgements
We would like to thank all the authors of the included
studies for the efforts they made to provide us with the
requested information on their studies. We would like to
thank Michael Draper, Medical Librarian, for his contribu-
tion in conducting the search strategy. We would like to
thank Bjorn Winkens, Assistant Professor, for his contribu-
tion in the data analysis.
Disclosure of interests
Ben Willem Mol provides consultancy to ObsEva, Guerbet
and Merck. The other authors have no conflicts of interest.
Contribution to authorship
MD, JG, and BWM had the idea for the study. MD and JG
selected studies and performed data extraction and analysis.
MD and JG wrote the first draft of the manuscript. CW,
DT, and BWM co-wrote the article.
Details of ethics approval
This study did not require ethical approval.
1094
Funding
No funding was involved in the development of this sys-
tematic review.
Supporting Information
Additional Supporting Information may be found in the
online version of this article:
Figure S1. Flow chart of study selection.
Table S1. Studies that report on an adverse events dur-
ing cervical ripening with a transcervical balloon catheter.
Table S2. (a) Reason for induction of labour in women
presenting with adverse events, per study.
Table S2. (b) Reason for induction of labour in women
presenting with adverse events, per adverse event (AE).
Appendix S1. Search strategy.
Appendix S2. List of excluded full articles.
Appendix S3. A detailed discussion of the adverse events
of the pooled data. &
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3 Gelber S, Sciscione A. Mechanical methods of cervical ripening and
labor induction. Clin Obstet Gynecol 2006;49:642–57.
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