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\begin{document}

\title{Safety and efficacy of the double balloon catheter and the prostaglandin
pessary: A multicentre randomised controlled trial}



\author[1]{Yang Huang Grace Ng}%
\author[2]{Anisah Aisyah  Aminuddin}%
\author[1]{Toh Lick Tan }%
\author[2]{Ramesh  Kuppusamy}%
\author[1]{Shephali Tagore}%
\author[3]{George Seow-Heong Yeo}%
\affil[1]{KK Women's and Children's Hospital}%
\affil[2]{University of Malaya Medical Centre}%
\affil[3]{KK Womens and Childrens Hospital}%


\vspace{-1em}



  
  \date{May 14, 2024}


\begingroup
\let\center\flushleft
\let\endcenter\endflushleft
\maketitle
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\selectlanguage{english}
\begin{abstract}
Objective We compare the adverse events in the 12 hours after double
balloon catheter(DBC) or first prostaglandin(PGE) inserted and the
efficacy of DBC to that of PGE in labour induction. Design Multi-centre
Randomised controlled Trial (RCT), in 2 centers with 2 arms: (i)DBC
(ii)prostaglandin pessary. Setting 2 tertiary hospitals, Singapore and
Malaysia Population Southeast-Asian women Method This is a prospective
cohort randomised controlled study. 210 women were recruited in each
center and assigned randomly to cervical ripening with either DBC or
prostaglandin pessary. Main outcome The adverse events in the 12 hours
after DBC or first PGE inserted and the efficacy of a DBC to that of a
prostaglandin in labour induction were evaluated. Results There were
significantly less women with uterine hyperstimulation in the double
balloon catheter group (2 vs 24, p=\textless{}0.0001) compared to the
prostaglandin group. There were no women with uterine hyperstimulation
and non-reassuring fetal status in the double balloon group while there
were 5 women with uterine hyperstimulation and fetal distress in the
prostaglandin group. Use of pain relief was significantly less in the
double balloon catheter group (p=0.009). There were no significant
differences in both groups in mode and time to delivery, although
significant less time was needed to achieve os dilation more than 4cm in
the double balloon catheter group (p=\textless{}0.0001). Conclusion DBC
remains a good alternative method for inducing women in view of low
adverse events and a good safety profile with low risk of
hyperstimulation. Keywords: Double balloon
catheter;prostaglandin;hyperstimulation;induction of labour
ClinicalTrials.govIdentifier:NCT02620215.URL:https://clinicaltrials.gov/ct2/show/NCT02620215%
\end{abstract}%



\sloppy


\emph{Safety and efficacy of the double balloon catheter and the
prostaglandin pessary: A multicentre randomised controlled trial}

Co authors

\begin{enumerate}
\tightlist
\item
  Ng Yang Huang Grace, MBChB, MRCOG. Department of Maternal Fetal
  Medicine, KK Women's and Children's Hospital, Singapore. 100 Bukit
  Timah Road, Singapore 229899
\item
  Anisa Aisyah Aminuddin, MRCOG. Department of Obstetrics and
  Gynaecology, University of Malaya Medical Centre. Kuala Lumpur,
  Malaysia. Lembah Pantai,59100. Kuala Lumpur, Malaysia.
\item
  Tan Toh Lick, MBBS, MRCOG. Department of Obstetrics and Gynaecology,
  KK Women's and Children's Hospital 100 Bukit Timah Road, Singapore
  229899. Thomson Women's Clinic.
\item
  Ramesh Kuppusamy, FRCOG, Department of Obstetrics and Gynaecology,
  University of Malaya Medical Centre. Kuala Lumpur, Malaysia. Lembah
  Pantai,59100. Kuala Lumpur, Malaysia.
\item
  Shephali Tagore, MBBS, MRCOG, Department of Maternal Fetal Medicine,
  KK Women's and Children's Hospital, Singapore. 100 Bukit Timah Road,
  Singapore 229899
\item
  George Seow Heong Yeo, FRCOG, FAMS, Department of Maternal Fetal
  Medicine, KK Women's and Children's Hospital, Singapore. 100 Bukit
  Timah Road, Singapore 229899
\end{enumerate}

\textbf{Correspondence:} Dr Ng Yang Huang Grace, Associate Consultant,
Department of Maternal Fetal Medicine, KK Women's and Children's
Hospital, 100 Bukit Timah Road, Singapore 229899. Tel: 62255554 Email:
Grace.ng.yang.huang@singhealth.com.sg

Shortened running Title: Safety and efficacy of the DBC and the PGE

\textbf{Abstract}

\emph{Objective}

We compare the adverse events in the 12 hours after double balloon
catheter(DBC) or first prostaglandin(PGE) inserted and the efficacy of
DBC to that of PGE in labour induction.

\emph{Design}

Multi-centre Randomised controlled Trial (RCT), in 2 centers with 2
arms: (i)DBC (ii)prostaglandin pessary.

\emph{Setting}

2 tertiary hospitals, Singapore and Malaysia

Population

Southeast-Asian women

\emph{Method}

This is a prospective cohort randomised controlled study. 210 women were
recruited in each center and assigned randomly to cervical ripening with
either DBC or prostaglandin pessary.

\emph{Main outcome}

The adverse events in the 12 hours after DBC or first PGE inserted and
the efficacy of a DBC to that of a prostaglandin in labour induction
were evaluated.

\emph{Results}

There were significantly less women with uterine hyperstimulation in the
double balloon catheter group (2 vs 24, p=\textless{}0.0001) compared to
the prostaglandin group. There were no women with uterine
hyperstimulation and non-reassuring fetal status in the double balloon
group while there were 5 women with uterine hyperstimulation and fetal
distress in the prostaglandin group. Use of pain relief was
significantly less in the double balloon catheter group (p=0.009). There
were no significant differences in both groups in mode and time to
delivery, although significant less time was needed to achieve os
dilation more than 4cm in the double balloon catheter group
(p=\textless{}0.0001).

\emph{Conclusion}

DBC remains a good alternative method for inducing women in view of low
adverse events and a good safety profile with low risk of
hyperstimulation.

Keywords: Double balloon
catheter;prostaglandin;hyperstimulation;induction of labour
ClinicalTrials.govIdentifier:NCT02620215.URL:https://clinicaltrials.gov/ct2/show/NCT02620215

Tweetable abstract: The double balloon catheter is a good alternative
method for inducing women in view of low adverse events and a good
safety profile with low risk of hyperstimulation.

\emph{Introduction}

In light of recent evidence in the literature advocating for elective
induction of uncomplicated singleton pregnancies at 39 weeks of
gestation, \textsuperscript{{[}1{]}} we can expect that induction of
labour (IOL), which is one of the most common procedures a woman may
experience in pregnancy, will become even more frequently employed. As
such, there is a pressing need to study the most optimal method of
cervical ripening among pharmacological, mechanical or surgical methods.

There are increasing amounts of evidence of safety and efficacy of
mechanical IOL including an updated publication of the Cochrane Database
of Systematic Reviews in 2012 \textsuperscript{{[}2{]}} and a NICE
interventional procedure guidance on the double balloon catheter
(DBC).\textsuperscript{{[}3{]}} A well-conducted meta-analysis by Du et
al. published in 2016 demonstrated that mechanical IOL with cervical
ripening balloons appeared to have similar efficacy profiles, and
greater safety and cost-effectiveness than prostaglandin (PGE2) agents.
A randomised-controlled study on 98 women in 2018 specifically
addressing patient experience between IOL methods found that pain during
induction was significantly lower with the double-balloon cervical
ripening balloon while other satisfaction and acceptability scores were
similar. \textsuperscript{{[}4{]}}

To the best of our knowledge, current large randomised controlled trials
have not directly examined the immediate effects or potential adverse
events that occur in the first 12 hours of double-balloon catheter or
first prostaglandin insertion in IOL. \textsuperscript{{[}5,
6,7,8,{]}}Outcomes on the efficacy and safety during this period will be
valuable to support its clinical application in high risk pregnancies.
We conducted a multi-centre study to specifically evaluate the use of
DBC in IOL in a Southeast-Asian population with regards to adverse
effects in 12 hours after insertion while using a non-incremental
balloon-filling regime.

\textbf{Methods}

This is a prospective cohort randomized controlled study conducted at
the KK Women's and Children's Hospital (KKH) and University Malaya
Medical Center (UMMC), teritary hospitals each with an approximate 11000
deliveries annually. The study was conducted from January 2015 to
January 2018. Local institutional review board approval was achieved in
both centers. 210 women were recruited in each center.
ClinicalTrials.gov Identifier: NCT02620215. Funding for the study was
supported by SingHealth Duke-NUS OBGYN Academic Clinical Program (ACP)
Grant.

The main hypothesis is DBC has no major adverse events including
hyperstimulation and non-reassuring fetal status in a 12-hour period
after DBC insertion, and its efficacy is non-inferior to prostaglandin
insertion. This will allow it to fulfil a current void in offering safer
outpatient induction. We attempt to address this hypothesis by
monitoring the periods of regular uterine contractions
(\textgreater{}1:10) measuring the frequency, length of contractions and
its association with adverse events during this period after
intervention. We also examined the efficiency of DBC in achieving a
favourable cervix for rupture of membranes or active labour at the end
of 12 hours compared with PGE2.

NICE guidelines on induction of labour \textsuperscript{{[}9{]}} defined
uterine hyperstimulation as contractions more than 5 in 10 min for more
than 20 min or contractions lasting more than 2 min in duration. A
retrospective study involving prostaglandin induction of
labour\textsuperscript{{[}10{]}} showed that hyperstimulation occurred
in 5.8\% of cases. Arbitrarily, we considered a relative 80\% decrease
in hyperstimulation risk (estimated hyperstimulation with DBC 1\%) as
clinically significant. Hence, assuming a significance level of 5\% and
power of 80\%, and allowing for a 5\% dropout rate, we estimated that
210 subjects would be needed per group (one-sided test).

Randomization of the women is achieved with third party sealed envelope
allocation. 210 envelopes containing DBC allocation and another 210
identical envelopes containing prostaglandin pessary allocation were
prepared by a third party. The 420 envelopes were shuffled according to
a computer randomization code after sealing and labelled with a
randomization allocation number from 1 to 420. Half of the envelopes
were handed to the each center's principal investigator, and kept in the
clinical store on labour ward together with the stock of DBC and
prostaglandin pessary.

Women requiring term IOL were identified in both centers and screened
with the inclusion and exclusion criteria (Box 1. Inclusion and
exclusion criteria). Once the written informed consent was obtained a
research assistant would disclose the intervention allocation.

In the group allocated the DBC, the catheter was inserted into the
cervical canal either under direct visualization with a sterile speculum
examination or via vaginal examination. After both balloons have entered
the cervical canal, the uterine balloon was filled with 40 ml of saline,
the catheter was then retracted and a vaginal examination was done to
ensure the DBC is in the cervical canal and the vaginal balloon was
inflated to 40 ml of saline. Both balloons were then inflated to 80 ml
each. The tubing was then taped to the woman's thigh. After the DBC was
put in place, a cardiotocogram was performed for 60 to 120 minutes and
the woman was allowed to ambulate. The double balloon catheter was left
in place for a maximum of 12 hours as per the manufacturer's advice.
Failed induction of labour was defined when labour was not initiated
after removal of the DBC.

In the group allocated the vaginal prostaglandin pessary, the pessary
was inserted and placed in the posterior vaginal fornix. After insertion
of the pessary, a cardiotocogram was performed for 60 to 120 min and the
woman was allowed to ambulate. After 6 hours, if the woman is not in
labour and the bishop score was still less than 6, a second dose of
prostaglandin was inserted and monitored as previously described. Failed
induction of labour was defined when labour was not initiated after
insertion of 2 pessaries.

The women were continuously monitored for uterine activity and
non-reassuring fetal status. During the first 12 hours of the
intervention, women were monitored for hyperstimulation defined when
there was more than 5 contractions for 10 min and hypertonus defined as
a single contraction lasting for more than 2 minutes. The type of pain
relief use was recorded (entonox, intramuscular pethidine or epidural).
Any vaginal bleeding that was more than a ``show'' was recorded.
Features of any non-reassuring heart rate was recorded and this was
defined in accordance to the NICE intrapartum care
guidelines.\textsuperscript{{[}11{]}} Decisions for caesarean section
based on cardiotocographs were made by obstetrician consultants on
labour ward.

After the DBC was removed or expelled, and if vaginal examination
revealed that the cervical os was more than 3 cm, membranes were
ruptured and oxytocin infusion was started for women who were not in
labour. For the prostaglandin group, during a vaginal examination, if
the cervical os was more than 3 cm, membranes were ruptured and oxytocin
infusion started 6 hours after the last dose of prostaglandin. Oxytocin
was administered using a standard regime in each hospital. Once in
active labour, standardized intrapartum care was given according to
hospital protocol.

All decisions for caesarean sections were made by obstetrician
consultants on labour ward. Failure to progress in first stage of labour
was defined as the absence of cervical change for 4 hours or more in the
presence of adequate uterine contractions and cervical dilation of at
least 4 cm. During second stage of labour women who were undelivered
with no progress with active pushing after at least 2 hours in
multiparous women and 3 hours in nulliparous women were diagnosed as
failure to progress.

Statistical analysis of outcomes data was performed with Chi squared
test and R software.

\textbf{Results}

During the study period, 420 patients were recruited, 210 from each
center. (Figure 1. Study Enrolment flowchart.)

In the DBC group, 3 women were excluded because of age criteria and
deviation from study protocol. One patient was excluded because of
prelabour rupture of membranes after randomisation and before the DBC
was inserted and 4 patients had incomplete data. During labour, 5
patients had malpresentation and had to undergo a caesarean section,
these patients were excluded from the analysis. In the prostaglandin
group, 4 patients were excluded because of age criteria and deviation
from study protocol, 4 patients were dilated to more than 3 cm after the
randomisation and before the insertion of the vaginal prostaglandin and
excluded. One patient was not induced as she declined induction of
labour after the randomisation. During labour, 3 patients had
malpresentation and had to undergo a caesarean section, they were also
excluded from the analysis. The demographics and baseline
characteristics were similar in both groups (Table 1). Indications for
induction of labour was not significant in both groups (Table S1).

The use of entonox is significantly more in the prostaglandin group than
the DBC group, while the use of intramuscular pethidine and epidural was
similar in both groups. The average induction to pain relief needed
interval was 6.57 (\selectlanguage{ngerman}± 2.83) hours in the prostaglandin group and 7.6 (±
2.72) hours in the DBC group. In the double balloon catheter group, 141
patients (71.9\%) did not need pain relief during the first 12 hours of
induction (Table 2).

Adverse events during the first 12 hours of induction were recorded
(Table 3). All patients who had hyperstimulation had intrauterine
resuscitation with a change to left lateral position and intravenous
hydration. Three patients needed tocolysis with intravenous terbutaline,
none required delivery due to persistent non-reassuring fetal status.
There were two cases of hyperstimulation occurred in the DBC arm, but
none had an impact on the fetal status. There were no incidences of
intrauterine deaths in both groups.

Although there was no difference in the time to delivery in both groups,
the time for dilation to 4 cm was significantly less in the DBC group
than the vaginal prostaglandin group (p\textless{}0.0001) (Figure 2.).
Oxytocin use for augmentation of labour was significantly higher in the
DBC group. 52 patients in the prostaglandin group, underwent spontaneous
rupture of membranes (p\textless{}0.0001). There were no significant
differences in the mode of delivery in both groups (Table 4). In the
prostaglandin group, a significant number of women had a cesarean
section because of failed IOL (p=0.0369), while a significant number of
patients who had the DBC allocation had a caesarean for failure to
progress in the first stage of labour.

Neonatal outcomes were similar in both study groups (Table S2).

\textbf{Discussion}

\emph{Main Findings}

To the best of our knowledge, this is the largest multi-centre Asian
population randomised controlled trial undertaken to evaluate the safety
of the DBC as well as the efficacy of the DBC compared to the vaginal
prostaglandin. Our findings show that the number of adverse events in
hyperstimulation and the use of entonox were significantly less in the
women allocated to the DBC group. Our study also showed similar labour
outcomes in both groups with regards to recourse to caesarean
deliveries. Average time to eventual delivery in both groups was
similar.

\emph{Strengths and Limitations}

The strength of the study include the multi-centre and randomisation
design with good power and patient numbers. A limitation of the study
was that it was impossible to blind the allocation to the investigator
or the patient. However, the investigator had no part in observing any
adverse events. The CTGs were interpreted and the need for intervention
determined by the attending clinicians. Hyperstimulation was
specifically defined and recorded by a third party studying the CTGs and
blinded to the patient's allocated group. The patient also reported
contractions intervals, pain scores, satisfaction scores with validated
standard pain and satisfaction assessment tools to minimize the
potential bias. Allocations were omitted from the database so as to
blind the analyst in order to prevent manipulation.

\emph{Interpretation}

Our findings are similar to Du et al. \textsuperscript{{[}12{]}} who
also showed a 10 times lower risk of hyperstimulation in the
double-balloon catheter group to the prostaglandin group. However, the
time to first use of pain relief and the percentage not requiring pain
relief in the first 12 hours was still similar in both groups, likely an
inherent development in labour induction.

A recent systematic review \textsuperscript{{[}13{]}} on the safety of
the balloon catheter used a random effects model. It included 26 studies
(8292 women) which estimated the prevalence of adverse events to be 0 to
0.26\%, ``pain and discomfort' being most common. In this study, none of
the included studies used a double balloon catheter. Our study provides
more data to support the good safety profile of the double balloon
catheter. Solt et al. \textsuperscript{{[}14{]}} compared the Bishop
score increment between a DBC and a single balloon catheter, he
concluded that the DBC was more effective that the single balloon
catheter with decreased time to delivery and decreased caesarean section
rates. The usage of a single balloon catheter in induction of labour is
off-licensed, and also requires traction.

Outpatient cervical ripening can be an attractive option because of the
potential for lower costs and patient satisfaction. This is only
possible if the method does not have an adverse effect on the fetus and
does not require medical interventions. Less fetal monitoring may be
required when DBC is used. In this regard, it may still be difficult for
the double catheter balloon to fulfil this role fully, even without
hyperstimulation, given the requirement for analgesia in the first 12
hours in 28.1\% of the patients.

Wilkinson et al \textsuperscript{{[}9{]}} ran a pilot randomised trial
comparing inpatient and outpatient balloon induction, they found that
patients in the outpatient arm felt less isolated and emotionally alone
while medical staff including midwives and doctors were more comfortable
with the use of a catheter as an option for outpatient ripening with
90\% supporting outpatient ripening with the catheter. A local
study\textsuperscript{{[}5{]}} also showed that the use of DBC showed
similar satisfaction and acceptability in the Singapore population, with
71\% of patients recommending the DBC as the mode for IOL.

Du et al's systemic review \textsuperscript{{[}12{]}} of 9 randomized
controlled studies concluded similar efficacy profiles between the
double balloon catheter and the prostaglandin E2. Our study also showed
similar labour outcomes in both groups with regards to recourse to
caesarean deliveries, but identified the difference in reasons however.
Caesarean delivery for failed induction was more common in the
prostaglandin group and failure to progress in the first stage of labour
more common in the DBC group. Average time to eventual delivery in both
groups was similar. Our study, in particular, demonstrated a more
predictable course of induction and significantly shorter time required
with the DBC from the initiation of IOL to achieving a cervical dilation
of more than 4 cm (91.3\% vs 67.6\%, p=\textless{}0.0001), although
artificial rupture of membranes and augmentation are more frequently
required. We believe this could offer significant advantage to
obstetricians in planning inductions for their patients, as well as
better patient satisfaction. A cost-efficacy study may be useful in
evaluating a best method of induction.

Currently, there are 9 randomized controlled
trials\textsuperscript{{[}6,15,16,17,18,19,20{]}} involving a double
balloon catheter. The balloon-filling regime is not standardized. In
this trial, we used a standardized non-incremental balloon-filling
regime prescribed according to the manufacturer's advice. This decreased
delays in achieving full inflation and decreased the time requiring
intensive monitoring of the fetus; hence, we would recommend this as the
standard balloon-filling regime for the double balloon catheter.

\textbf{Conclusion}

Our study shows low uterine hyperstimulation and a good safety profile
of the double balloon catheter in the induction of labour, with a more
predictable and shorter course of induction. DBC may have a place in
high risk pregnancies such as growth restricted fetuses.

\textbf{Acknowledgements}

We would like to thank all the participants of the trial, KK Women and
Children's Hospital and UMMC hospital labour ward staff providing
assistance in data collection. We would like to thank Dr Janice Tung for
her contribution to the study.

\textbf{Disclosure of Interest}

No potential conflict of interest was reported by the authors.

\textbf{Contribution to Authorship}

NYHG was involved in conception, planning and carrying out the study
with recruitment of women, analysing the results and writing the
manuscript. AAA was involved in carrying out the study and recruitment
of the patients, collection of data for the study in UMMC and reviewing
of the manuscript. TTL was involved in the conception and planning of
the study and editing the manuscript. RK was involved in the conception,
planning of the study, carrying out of the study in UMMC and reviewing
the manuscript. ST was involved in the conception, planning, carrying
out of the study and editing of the manuscript. GYSH was involved in the
conception, planning, carrying out of the study and reviewing the
manuscript.

\textbf{Details of Ethics approval}

Singapore Centralised Institutional Review Board, Date of approval:
16-Oct-2015, Reference number 201506-00112

\textbf{Funding}

Funding for the study was supported by SingHealth Duke-NUS OBGYN
Academic Clinical Program (ACP) Grant.

References:

Grobman WA, Rice MM, Reddy UM, Tita AT, Silver RM, Mallet G et al. Labor
induction versus expectant management for low-risk nulliparous
women.~New England Journal of Medicine2018; DOI: 10.1056/NEJMoa1800566

Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M.
Mechanical methods for induction of labour. Cochrane Database Syst Rev.
2012 Mar 14;3.

National Institute for Health and Clinical Excellence (NICE). Insertion
of a double balloon catheter for induction of labour in pregnant women
without previous caesarean section: Interventional procedures guidance.
London: National Institute for Clinical Excellence; 2015.

Lim SE, Tan TL, Ng GYH, Tagore S, Kyaw EEP, Yeo GSH. Patient
satisfaction with the cervical ripening balloon as a method for
induction of labour: a randomised controlled trial.~Singapore Med J.
2018;59(8):419--424. doi:10.11622/smedj.201809.

Løkkegaard E1, Lundstrøm M, Kjær MM, Christensen IJ, Pedersen HB, Nyholm
H. Prospective multi-centre randomised trial comparing induction of
labour with a double-balloon catheter versus dinoprostone. J Obstet
Gynaecol. 2015 Feb 18:1-6.

Wilkinson C, Bryce R, Adelson P, Turnbull D.A randomised controlled
trial of outpatient compared with inpatient cervical ripening with
prostaglandin E\selectlanguage{english}2 (OPRA study). BJOG. 2015 Jan;122(1):94-104.

Howard K, Gerard K, Adelson P, Bryce R, Wilkinson C, Turnbull D. Women's
preferences for inpatient and outpatient priming for labour induction: a
discrete choice experiment. BMC Health Serv Res. 2014 Jul 30;14:330.
doi: 10.1186/1472-6963-14-330.

Wilkinson C, Bryce R, Adelson P, Turnbull D. A comparison of inpatient
and outpatient balloon catheter cervical ripening pilot randomised
controlled trial. BMC 2015:15;126.

National Institute for Health and Clinical Excellence (NICE). Induction
of labor: clinical guideline no. 70. London: National Institute for
Clinical Excellence; 2008.

Egarter CH, Husslein PW, Rayburn WF. Uterine hyperstimulation after
low-dose prostaglandin E2 therapy: tocolytic treatment in 181 cases.
ACOG 1990:163(3):794-79.

National Institute for Health and Clinical Excellence (NICE).
Intrapartum care for healthy women and babies: clinical guideline no.
190. London: National Institute for Clinical Excellence; 2014

Du YM, Zhu LY, Cui LN, Jin BH, Ou JL. Double-balloon catheter versus
prostaglandin E2 for cervical ripening and labour induction: a
systematic review and meta-analysis of randomised controlled trials.
BJOG 2016; DOI: 10.1111/1471-0528.14256. Epub 2016 Aug 17

Diederen M, Gommers J, Wilkinson C, Turnbull D, Mol B. 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
Aug;125(9):1086-1095. doi: 10.1111/1471-0528.15047. Epub 2018 Jan 10

Solt I, Wolf MF, Ben-Haroush S, Kaminskyi S, Ophir E, Bornstein J. Foley
catheter versus cervical double balloon for labor induction: a
prospective randomized study,~J Matern Fetal Neonatal Medicine. 2019;
11:1-8

Salim R,~Zafran N,~Nachum Z,~Garmi G,~Kraiem N,~Shalev E. Single-balloon
compared with double balloon catheters for induction of labor: a
randomized controlled trial Obstet Gynecol.~2011 Jul;118(1):79-86

Mei-Dan E, Walfisch A, Suarez-Easton S, Hallak M.~Comparison of two
mechanical devices for cervical ripening: a prospective quasi-randomized
trial.~J Matern Fetal Neonatal Med 2012;~25:6,~723-727.

Pennell C, Henderson J, O'Neill M, McCleery S, Doherty D. Induction of
labour in nulliparous women with an unfavourable cervix: a randomised
controlled trial comparing double and single balloon catheters and PGE2
gel. BJOG 2009;116:1443-1452.

Kehl S, Ziegler J, Schleussner E, Tuschy B, Berlit S, Kirscht J et al.
Sequential use of double-balloon catheter and oral misoprostol versus
oral misoprostol alone for induction of labour at term (CRBplus trial):
a multicentre, open-label randomised controlled trial. BJOG
2015;122(1):129-136.

Cromi A, Ghezzi F, Uccella S, Agosti M, Serati M, Marchitelli G et al. A
randomized trial of preinduction cervical ripening: dinoprostone vaginal
insert versus double-balloon catheter. ACOG 2012;207:125-127

Atad J, Hallak M, Auslender R, Porat-Packer T, Zarfati D, Abramovici H.
A randomized comparison of prostaglandin E2, oxytocin, and the
double-balloon device in inducing labor. Obstet Gynecol. 1996;87:
223-227



\textbf{Table 1. Demographics and baseline characteristics.}\selectlanguage{english}
\begin{longtable}[]{@{}llllll@{}}
\toprule
\begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
DBC\strut
\end{minipage} & \begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
DBC\strut
\end{minipage} & \begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
Prostin\strut
\end{minipage} & \begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
Prostin\strut
\end{minipage} & \begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
P\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
IOL to \textgreater{}4cm dilation,hr (n)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
13.87 (179)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±7.51\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
19.08 (134)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±10.59\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\textbf{\textless{}0.0001}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
IOL to full dilation, hr (n)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
20.23 (117 )\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±8.37\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
20.21 (120)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±11.48\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.5061\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
IOL to vaginal delivery, hr (n)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
20.16 (130)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±8.38\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
20.87 (143)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±11.54\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.2794\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
IOL to delivery, hr (n)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
22.42 (196)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±8.84\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
23.78 (198)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±13.4\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.1173\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
Duration of 2\textsuperscript{nd} stage, hr (os full to delivery)
(n)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.78 (117 )\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±0.99\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.79 (120)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±1.13\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.4711\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Delivery within 24h (Vaginal Delivery)\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
91\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
94\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.9147\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Failed IOL\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
12\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
28\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\textbf{0.01358}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
1\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
6\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
99\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
NA\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
2\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
4\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
71\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
3\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
-\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
24\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
4\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
-\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
4\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Use of oxytocin for augmentation\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
152\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
109\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\textbf{\textless{}0.0001}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
SROM\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
20\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
52\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\textbf{\textless{}0.0001}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Use of Epidural \textbackslash{}soutuse\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
86\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
84\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.8497\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Vaginal delivery\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
112\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
119\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.6214\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Instrumental delivery\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
18\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
24\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.4345\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Caesarean section\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
66\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
55\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.2464\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Failed IOL\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
3\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
12\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\textbf{0.03697}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
FTP in 1\textsuperscript{st} stage of labour\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
41\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
18\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\textbf{0.0016}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
FTP in 2\textsuperscript{nd} stage of labour\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
2\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
2\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
1\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
NRFS (Non-reassuring fetal status)\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
20\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
22\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.8978\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
Pyrexia in labour Temperature \textgreater{}37.5 C\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
30\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
20\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.1613\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
WICU admission\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
2\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
2\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
1\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}



\textbf{Table 2. Pain relief during the first 12h of induction}\selectlanguage{english}
\begin{longtable}[]{@{}llllll@{}}
\toprule
\begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
DBC\strut
\end{minipage} & \begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
DBC\strut
\end{minipage} & \begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
Prostin\strut
\end{minipage} & \begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
Prostin\strut
\end{minipage} & \begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
P\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
IOL to \textgreater{}4cm dilation,hr (n)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
13.87 (179)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±7.51\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
19.08 (134)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±10.59\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\textbf{\textless{}0.0001}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
IOL to full dilation, hr (n)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
20.23 (117 )\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±8.37\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
20.21 (120)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±11.48\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.5061\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
IOL to vaginal delivery, hr (n)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
20.16 (130)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±8.38\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
20.87 (143)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±11.54\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.2794\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
IOL to delivery, hr (n)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
22.42 (196)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±8.84\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
23.78 (198)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±13.4\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.1173\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
Duration of 2\textsuperscript{nd} stage, hr (os full to delivery)
(n)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.78 (117 )\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±0.99\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.79 (120)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±1.13\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.4711\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Delivery within 24h (Vaginal Delivery)\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
91\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
94\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.9147\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Failed IOL\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
12\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
28\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\textbf{0.01358}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
1\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
6\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
99\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
NA\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
2\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
4\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
71\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
3\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
-\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
24\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
4\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
-\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
4\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Use of oxytocin for augmentation\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
152\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
109\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\textbf{\textless{}0.0001}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
SROM\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
20\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
52\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\textbf{\textless{}0.0001}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Use of Epidural \textbackslash{}soutuse\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
86\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
84\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.8497\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Vaginal delivery\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
112\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
119\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.6214\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Instrumental delivery\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
18\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
24\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.4345\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Caesarean section\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
66\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
55\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.2464\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Failed IOL\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
3\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
12\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\textbf{0.03697}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
FTP in 1\textsuperscript{st} stage of labour\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
41\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
18\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\textbf{0.0016}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
FTP in 2\textsuperscript{nd} stage of labour\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
2\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
2\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
1\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
NRFS (Non-reassuring fetal status)\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
20\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
22\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.8978\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
Pyrexia in labour Temperature \textgreater{}37.5 C\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
30\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
20\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.1613\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
WICU admission\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
2\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
2\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
1\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}



\textbf{Table 3. Adverse events during the first 12h of induction}\selectlanguage{english}
\begin{longtable}[]{@{}llllll@{}}
\toprule
\begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
DBC\strut
\end{minipage} & \begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
DBC\strut
\end{minipage} & \begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
Prostin\strut
\end{minipage} & \begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
Prostin\strut
\end{minipage} & \begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
P\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
IOL to \textgreater{}4cm dilation,hr (n)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
13.87 (179)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±7.51\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
19.08 (134)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±10.59\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\textbf{\textless{}0.0001}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
IOL to full dilation, hr (n)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
20.23 (117 )\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±8.37\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
20.21 (120)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±11.48\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.5061\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
IOL to vaginal delivery, hr (n)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
20.16 (130)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±8.38\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
20.87 (143)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±11.54\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.2794\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
IOL to delivery, hr (n)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
22.42 (196)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±8.84\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
23.78 (198)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±13.4\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.1173\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
Duration of 2\textsuperscript{nd} stage, hr (os full to delivery)
(n)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.78 (117 )\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±0.99\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.79 (120)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±1.13\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.4711\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Delivery within 24h (Vaginal Delivery)\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
91\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
94\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.9147\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Failed IOL\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
12\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
28\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\textbf{0.01358}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
1\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
6\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
99\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
NA\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
2\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
4\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
71\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
3\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
-\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
24\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
4\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
-\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
4\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Use of oxytocin for augmentation\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
152\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
109\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\textbf{\textless{}0.0001}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
SROM\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
20\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
52\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\textbf{\textless{}0.0001}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Use of Epidural \textbackslash{}soutuse\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
86\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
84\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.8497\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Vaginal delivery\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
112\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
119\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.6214\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Instrumental delivery\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
18\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
24\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.4345\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Caesarean section\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
66\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
55\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.2464\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Failed IOL\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
3\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
12\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\textbf{0.03697}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
FTP in 1\textsuperscript{st} stage of labour\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
41\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
18\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\textbf{0.0016}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
FTP in 2\textsuperscript{nd} stage of labour\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
2\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
2\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
1\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
NRFS (Non-reassuring fetal status)\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
20\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
22\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.8978\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
Pyrexia in labour Temperature \textgreater{}37.5 C\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
30\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
20\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.1613\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
WICU admission\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
2\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
2\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
1\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}



\textbf{Table 4. Labour outcomes of women undergoing cervical ripening
balloon (DBC and Prostin (PGE)}\selectlanguage{english}
\begin{longtable}[]{@{}llllll@{}}
\toprule
\begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
DBC\strut
\end{minipage} & \begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
DBC\strut
\end{minipage} & \begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
Prostin\strut
\end{minipage} & \begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
Prostin\strut
\end{minipage} & \begin{minipage}[b]{0.14\columnwidth}\raggedright\strut
P\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
IOL to \textgreater{}4cm dilation,hr (n)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
13.87 (179)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±7.51\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
19.08 (134)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±10.59\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\textbf{\textless{}0.0001}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
IOL to full dilation, hr (n)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
20.23 (117 )\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±8.37\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
20.21 (120)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±11.48\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.5061\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
IOL to vaginal delivery, hr (n)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
20.16 (130)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±8.38\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
20.87 (143)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±11.54\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.2794\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
IOL to delivery, hr (n)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
22.42 (196)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±8.84\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
23.78 (198)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±13.4\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.1173\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
Duration of 2\textsuperscript{nd} stage, hr (os full to delivery)
(n)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.78 (117 )\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±0.99\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.79 (120)\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\selectlanguage{ngerman}±1.13\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.4711\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Delivery within 24h (Vaginal Delivery)\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
91\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
94\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.9147\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Failed IOL\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
12\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
28\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\textbf{0.01358}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Number of PGE used\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
1\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
6\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
99\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
NA\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
2\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
4\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
71\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
3\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
-\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
24\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
4\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
-\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
4\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Use of oxytocin for augmentation\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
152\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
109\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\textbf{\textless{}0.0001}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
SROM\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
20\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
52\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\textbf{\textless{}0.0001}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Use of Epidural \textbackslash{}soutuse\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
86\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
84\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.8497\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Vaginal delivery\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
112\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
119\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.6214\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Instrumental delivery\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
18\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
24\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.4345\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Caesarean section\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
66\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
55\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.2464\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Indication for CS\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
Failed IOL\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
3\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
12\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\textbf{0.03697}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
FTP in 1\textsuperscript{st} stage of labour\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
41\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
18\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\textbf{0.0016}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
FTP in 2\textsuperscript{nd} stage of labour\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
2\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
2\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
1\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
NRFS (Non-reassuring fetal status)\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
20\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
22\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
0.8978\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
Pyrexia in labour Temperature \textgreater{}37.5 C\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
30\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
20\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.16\columnwidth}\raggedright\strut
0.1613\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
WICU admission\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
2\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
2\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.14\columnwidth}\raggedright\strut
1\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}

\textbf{Hosted file}

\verb`Figure 1 enrolment.doc`  available at \url{https://authorea.com/users/302719/articles/432806-safety-and-efficacy-of-the-double-balloon-catheter-and-the-prostaglandin-pessary-a-multicentre-randomised-controlled-trial}

\textbf{Hosted file}

\verb`Figure 2 Kaplan.docx`  available at \url{https://authorea.com/users/302719/articles/432806-safety-and-efficacy-of-the-double-balloon-catheter-and-the-prostaglandin-pessary-a-multicentre-randomised-controlled-trial}

\selectlanguage{english}
\FloatBarrier
\end{document}

