Membrane Sweeping Versus Transcervical Foley Catheter for Induction of Labour in Women With Previous Caesarean Delivery
Phase: NA
Conditions: Labour, Induced, Vaginal Birth After Caesarean
Sponsor: Ministry of Health, Malaysia

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PROPOSAL
Study Title:
MEMBRANE 
SWEEPING 
VERSUS 
TRANSCERVICAL 
FOLEY
CATHETER FOR INDUCTION OF LABOUR IN WOMEN WITH
PREVIOUS CAESAREAN DELIVERY
Clinical Study Protocol Version
: 2.0
Study Initiation Date
: 15 November 2017
Study Completion Date
: 24 September 2018
Date of Protocol
: 14 August 2017
Amendment number(s)
: 1
Author(s):
Name
Role
Dr. Yong Soon Leong
Principal/Coordinating Investigator
Dr. Joyce Ting Chin Sing
Principal Investigator at the site
Dr. Ling Tin Yee
Principal Investigator at the site
Organisations / Institutes:
Department of O&G, Sibu Hospital
Sponsor:
This study is self-funded by Department of O&G, Sibu Hospital. No grant is applied.
Conflict of interest:
There is no conflict of interest among members of the study team.

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BACKGROUND/LITERATURE REVIEW
Induction of labour (IOL) is an obstetric intervention to artificially initiate labour before
its spontaneous onset (1, 2). It is undertaken when maternal or fetal risks of continuing
pregnancy outweigh the risks of IOL (1). The methods of IOL include pharmacological method
(prostaglandin), mechanical methods (transcervical Foley catheter and laminaria tents) and
surgical method (amniotomy). Pharmacological method and mechanical methods are preferred
choice for IOL in women with unfavourable cervix. Whereas surgical method is reserved for
women with favourable cervix in which membranes are accessible.
With the global rise in Caesarean section, more and more women embark on pregnancy
with previous Caesarean scar (3). It is estimated that one in every four term pregnancies
requires IOL (4). With IOL in previous Caesarean section, the risk of uterine scar rupture with
subsequent catastrophic maternal and neonatal outcomes is the greatest concern (5). Previous
influential study (6) highlighted that IOL with prostaglandin conferred the greatest risk of
uterine rupture (2.45%) in women with one previous Caesarean delivery. On the other hand,
the risks of uterine rupture were lower and comparable among women whose labour induced
without the use prostaglandin (0.77%) and women with spontaneous labour (0.52%). Among
the various IOL methods, prostaglandin is more likely associated with shorter interval to
achieve vaginal delivery and avoidance of oxytocin augmentation (7). Nevertheless,
mechanical methods have lower risk of uterine hyperstimulation (7, 8) but have more risk of
infection (7). As a result, obstetricians are facing dilemma on deciding the safe and effective
method of IOL in women with previous Caesarean delivery.
In Sibu Hospital, membrane sweeping is routinely offered to women with previous
Caesarean delivery who require IOL. This technique involves the examining finger passing
through the cervix to rotate against the wall of the uterus, to separate the chorionic membrane
from the decidua, or to massage around the cervix if the os is closed (1, 2). However, membrane
sweeping may not exert its cervical ripening effect immediately and the delivery may be
delayed by up to 8 days (9). This may render a proportion of women to resort to repeated
Caesarean section for failed induction. The vaginal birth rates following membrane sweeping
in women with unscarred uterus are ranging between 78%-90% (10-12). Among women with
previous Caesarean delivery undergoing IOL with membrane sweeping, the reported vaginal
birth rates were conflicting. A randomised controlled trial by Hamdan et al. showed vaginal

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birth rate of 56.1% (13). Another comparative study by Ramya et al. reported much lower
vaginal birth rate of 17.3% which could be explained by high rate of Caesarean Section for
maternal request in this study (14). The average intervals from sweeping to labour onset and to
delivery were about 2 days (14) and 4 days (9), respectively. Membrane sweeping did not
increase the risk of maternal or neonatal infection, Caesarean section, postpartum haemorrhage
and neonatal poor APGAR score, though discomfort during vaginal examination, minor
vaginal bleeding and irregular contraction were frequently reported by women undergoing
membrane sweeping (13, 15). No cases of uterine rupture was reported among women with
scarred uterus undergoing membrane sweeping (14).
Pharmacological IOL method involving prostaglandin is avoided in Sibu Hospital in
view of higher risk of scar rupture and presence of limited number of consultants to cope with
this debilitating event. Non-pharmacological methods of IOL such as Foley catheter, double-
balloon catheter, hygroscopic cervical dilator (laminaria tent) etc are known to have lesser risk
of scar rupture. Double-balloon catheters are limited in numbers in this hospital and they are
costly. Laminaria tent is not available in this hospital. Foley cathter is a consumable item in
this hospital and thus is readily available all the time. Compared to double-balloon catheter,
Foley catheter has equivalent cervical ripening efficacy and safety profile (16). In addition,
Foley catheter is also cheaper and has shorter induction to delivery interval. All these
advantages make Foley catheter an ideal method of IOL for women with previous Caesarean
delivery.
Among women with previous Caesarean delivery underlying IOL with transcervical
Foley catheter, the reported vaginal birth rates are ranging between 43.5%-71.4% (17-25). The
retrospective cohort analysis by Bujold et al. (18) compared the risk of uterine rupture among
women with previous Caesarean delivery undergoing spontaneous labour, induction by
amniotomy with or without oxytocin, or preinduction cervical ripening with transcervical Foley
catheter. The rates of uterine rupture were similar among the groups ((1.1% vs 1.2% vs 1.6%,
p = 0.81). However, transcervical Foley catheter appeared to be safer than low dose oxytocin
infusion for cervical ripening before amniotomy as the latter tended to be associated with risk
of uterine scar dehiscence (26). Another retrospective cohort study done by Gonsalves et al.
showed no case of uterine rupture among 68 women with previous Caesarean section
undergoing IOL with transcervical Foley catheter insertion (25).

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The transcervical insertion of balloon catheter as a ‘foreign material’ may theoretically
increase the risk of uterine infection. But, the current data available are conflicting. Meta-
analysis by Heinemann et al. (27) demonstrated that the Foley catheter was associated with a
significantly higher rate of maternal infections, defined as fever, endometritis or
chorioamnionitis, compared to the use of prostaglandins or oxytocin for induction of labor
(7.6% vs 5%, pooled OR 1.5, 95%CI 1.07–2.09). On the other hand, Cochrane Review (8)
concluded that there is no evidence of an increased risk of infectious morbidity with balloon
catheters. In the PROBAAT-trial (28), comparing the Foley catheter with the use of vaginal
prostaglandin E2 gel, the rate of intrapartum infection was significantly lower in women with
the Foley catheter (1% vs 3%, p = 0.035). Two other trials evaluating labor induction with
balloon catheters after rupture of the membranes did not show an increased risk for maternal
infection (29, 30).
Maslovitz et al. (31) reported the rate of vaginal bleeding of 1.8% following
transcervical Foley catheter insertion. However, the bleeding was minor with unaltered
haemoglobin levels and coagulation profile. There was also no case of cervical tear which
might result in postpartum haemorrhage. Besides, risk of change of fetal vertex presentation to
breech was reported to be 1.3% (31). This was probably related to concomitant presence of
unengaged free-floating fetus and contraction following Foley catheter insertion which resulted
in flipping movement of the fetus. Risk of poor APGAR and NICU admission was not
significantly higher compared to other IOL methods eg. prostaglandin and oxytocin (24, 26).
Till date, there is paucity of evidence on the superiority of membrane sweeping and
transcervical Foley catherter in IOL in previous Caesarean delivery. Both methods have the
same mechanism action by increasing local production of endogenous prostaglandin (1). The
aim of this study is to evaluate the effectiveness of membrane sweeping and transcervical Foley
catherter insertion for IOL in women with previous Caesarean delivery.
OBJECTIVES AND PURPOSE
1. General objective:
a.
To compare the effectiveness of membrane sweeping and transcervical Foley
catheter for IOL in women with one previous Caesarean delivery.

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2. Specific objectives:
a.
To compare the following induction outcomes between membrane sweeping
and transcervical Foley catheter for IOL in women with one previous Caesarean
delivery.
i. Improvement of modified Bishop score at interval of 24 hours and 48
hours, respectively.
ii. The requirement of oxytocin following IOL.
b. To compare the following delivery outcomes between membrane sweeping and
transcervical Foley catheter for IOL in women with one previous Caesarean
delivery.
i. Mode of delivery.
ii. Overall:

Induction to delivery interval.

Oxytocin augmentation duration.
iii. Vaginal delivery subgroup:

Induction to delivery interval.

Amniotomy to delivery interval.

Duration of oxytocin augmentation.

Vaginal delivery rate within 24 hours of induction.

Vaginal delivery rate between 24-48 hours of induction.
c.
To compare the maternal outcomes between membrane sweeping and
transcervical Foley catheter for IOL in women with one previous Caesarean
delivery.
i. Uterine hyperstimulation.
ii. Uterine rupture.
iii. Post-partum haemorrhage.
iv. Maternal pyrexia.
v. Duration of hospitalization.
d. To compare the neonatal outcomes between membrane sweeping and
transcervical Foley catheter for IOL in women with one previous Caesarean
delivery.
i. APGAR score at 5 minutes.
ii. Cord pH.

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e.
To compare women’s evaluation on the care they receive between membrane
sweeping and transcervical Foley catheter for IOL.
STATEMENT ON ETHICAL ISSUES
1. Institutional Review Board (IRB) Review:
a.
The study protocol will be reviewed by Medical Research Ethics Committee
(MREC) of Ministry of Health, Malaysia.
2. Patient information sheet and informed consent:
a.
Written informed consent will be obtained from each subject prior to the
enrollment.
b. Subjects will be told of the objective of this study in clear laymen’s term. They
will be informed of their rights as subjects and that their participation is
voluntary.
c.
Subjects will also be notified that if they choose to withdraw from the study at
any time, they will be managed according to local protocol under Department
O&G, Sibu Hospital.
d. The information sheet specifies whom the contact if they are injuries as a result
of the study, and whom to contact with general information about the study.
e.
The consent form specifies that the study staff, and governmental or regulatory
authorities, have direct access to subject’s medical record in order to make sure
that the study is conducted correctly and the data are recorded correctly.
f.
Compliance with informed consent will be monitored by the principal
investigators.
TRIAL DESIGN
1. Study location:
a.
This study will be conducted in the Department of Obstetrics and Gynaecology,
Sibu Hospital, Sarawak.

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2. Study design:
a.
A prospective randomised controlled trial (RCT) will be conducted.
b. The subjects will be followed-up from time of IOL till delivery.
3. Study endpoint:
a.
The study endpoint is to confirm the superiority of membrane sweeping and
transcervical Foley catheter for IOL in women with one previous Caesarean
delivery.
4. Study duration:
a.
This study will be conducted from 15 November 2017 till 24 September 2018.
5. Study procedure: (see flow chart in Appendix 1)
a.
Approval will be obtained from the Medical Research & Ethics Committee,
Ministry of Health Malaysia before conducting the study.
b. Pregnant women with one previous Caesarean section who are indicated for
IOL and eligible will be recruited in the study.
c.
Informed consent available in either English or Malay language (See Appendix
2) will be obtained prior to enrollment into the study. The consent will be taken
by the principal investigator at time of admission in Sibu Hospital Labour Ward.
d. A data collection form will be filled up and details including personal
information will be obtained (Appendix 3).
e.
Eligible subjects will be randomly assigned to one of the treatment groups
below.
i. Group 1: IOL with membranes sweeping
ii. Group 2: IOL with transcervical Foley catheter
f.
Blocked randomisation, in a block size of 6 and an allocation ratio of 1:1, will
be performed using a computer-generated randomisation sequence by Research
Randomizer (available online at https://www.randomizer.org/). The allocation
assignment indicating “membrane sweeping” or “transcervical Foley catheter”
will be sealed in sequentially numbered, opaque envelopes by principal
investigator, . Envelopes will be kept in a locked box in Labour Ward. When
study consent is signed, the next sequential envelope will be taken out from the
box and opened to determine allocation.

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g. This is a non-blinded study in which subjects, medical staffs, and investigators
are not blinded to group assignment. This is because both IOL methods are
distinctly different procedure. However, both intervention arms are considered
receiving equal treatment. In term of safety, both membrane sweeping and
transcervical Foley catheter are non-pharmacological in nature and thus the risk
of scar rupture does not differ in both methods. In term of efficacy, there is no
previous study to compare effectiveness between these two methods. Individual
studies revealed that membrane sweeping is likely to reduce the need for formal
IOL in post-date pregnancy and transcervical Foley catheter could improve
cervical favourability.
h. IOL will be done on the next morning. Pre-induction cardiotocograph (CTG)
will be performed to ensure normal fetal heart rate prior to IOL.
i.
In Group 1, membrane sweeping involves the insertion of a digit past the
internal cervical os followed by three circumferential passes of the digit causing
separation of the membranes from the lower uterine segment. When the cervix
is closed, a massage of the cervical surface for 15 to 30 seconds will be
performed instead. Membrane sweeping will be undertaken twice a day at 8 to
10 hours apart.
j.
In Group 2, transcervical Foley catheter No. 18 F will be inserted under aseptic
technique into the endocervical canal surpassed beyond the internal os. The
balloon will be inflated with 60 ml of sterile water and the catheter is plastered
to patient’s thigh with gentle traction. The catheter will be checked for its
position and the traction at 6 hours interval. If it were expelled spontaneously,
it would not be re-inserted. Otherwise, the catheter will be removed after 24
hours.
k. Post-induction CTG will be performed at 1 hour after the first membrane
sweeping in Group 1 and after transcervical Foley catheter insertion in Group
2.
l.
The uterine contractions, maternal temperature and fetal heart rate (via handheld
Doppler device) will be monitored every 4 hours.
m. After 24 hours, improvement of modified Bishop score will be assessed.
i. If the cervix is favourable for amniotomy, amniotomy will be performed
followed by augmentation with intravenous oxytocin.

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ii. If the cervix is still unfavourable and amniotomy is impossible,
membrane sweeping will be continued for one more day in Group 1
whereas conservative management will be undertaken for one day in
Group 2. Suitability for amniotomy will be reassessed on the next day.
n. After amniotomy, subsequent intrapartum management will be based on the
hospital protocol.
o. Oxytocin augmentation will be started when desired contractions are not
achieved at 2 hours after amniotomy or labour progress falls below the action
line of partogram.
p. Our oxytocin infusion regime begins with 2 mU/min. An increment in dosage
is made every 30 minutes until desired contractions of 3-4 in 10 minutes lasting
45-60 seconds. The maximum oxytocin dose is 16 mU/min.
q. Continuous CTG monitoring will be undertaken throughout the labour process.
r.
Oxytocin augmentation will not be started or will be withheld when there is
non-reassuring fetal heart rate.
s.
If amniotomy is still impossible after 2 days of IOL, the ward Obstetrician will
discuss with women regarding option of Caesarean section.
6. Criteria for suspending or terminating the study:
a.
Transcervical Foley catheter is found to have unreasonable and significant risks
to subjects. The risks include uterine rupture, maternal sepsis, severe cervical
trauma, and neonatal sepsis. However, all these serious adverse outcomes were
infrequent risk based on literature review. Literature review showed that the risk
of uterine rupture in Foley catheter arm is comparable to women with scarred
uterus undergoing spontaneous labour (18, 25). There is small risk of maternal
pyrexia or infection but no case of maternal or neonatal sepsis was reported (8,
28-30). Similarly, no case of cervical trauma was reported as well (31).
7. Study instruments:
a.
Data collection form which consists of:
i. SECTION A: Subjects’ demographic information (gravida, parity,
gestational age, maternal height and weight, body mass index, details of
previous Caesarean delivery, indication of IOL).

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ii. SECTION B: Subjects’ induction outcomes (serial changes in modified
Bishop score).
iii. SECTION C: Subjects’ delivery outcomes (oxytocin requirement, mode
of delivery, induction to delivery interval, overall duration of oxytocin
augmentation, intrapartum details for the vaginal delivery (including
instrumental delivery) subgroup, estimated blood loss, maternal and
neonatal outcomes.
iv. SECTION D: ‘Subjects’ satisfaction on the care they received.
b. Membrane sweeping:
i. An IOL method involving the insertion of a digit past the internal
cervical os followed by three circumferential passes of the digit causing
separation of the membranes from the lower uterine segment.
ii. When the cervix is closed, a massage of the cervical surface for 15 to 30
seconds will be performed instead.
c.
Transcervical Foley catheter:
i. An IOL method involving insertion of a balloon catheter under aseptic
technique into the endocervical canal surpassed beyond the internal os.
ii. The balloon will be inflated with 60 ml of sterile water and the catheter
is plastered to patient’s thigh with gentle traction.
iii. Foley catheter is an indwelling catheter made of latex rubber.
d. Modified Bishop score: (see Figure 1)
i. A group of measurements made at internal examination, used to
determine whether the cervix is favourable or not.
ii. The score is based on the station, dilation, effacement (or length),
position and consistency of the cervix.
iii. A score of 8 or more generally indicates that the cervix is ripe (2).
Figure 1: modified Bishop score
Score
0
1
2
3
Dilatation (cm)
1
1-2
3-4
>4
Length of cervix (cm)
>4
2-4
1-2
<1
Station
-3
-2
-1
0
Consistency
Firm
Average
Soft
-

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Position
Posterior
Mid/Anterior
-
-
SELECTION AND WITHDRAWAL OF SUBJECTS
1. Sample population:
a.
All pregnant women with one previous Caesarean section who are admitted to
Sibu Hospital for IOL will be recruited in the study.
2. Inclusion criteria:
a.
The inclusion criteria are age at least 18 years old, gestational age ≥ 37 weeks,
singleton pregnancy, reassuring fetal status and modified Bishop score ≤ 6.
3. Exclusion criteria:
a.
Women with ruptured membranes, intrauterine death, polyhydramnios, severe
fetal anomalies, multiple pregnancy.
b. Women with contraindications for IOL eg. placenta previa, suspected
macrosomia, suspected cephalopelvic disproportion, non-cephalic presentation,
and obstructive pelvic masses.
4. Sample size determination:
a.
We had searched electronic databases including PubMed, Cochrane Library,
Scopus, Ovid, JSTOR and Google Scholar. We found that there was no study
comparing the two IOL methods, thus no prior information is available for
sample size calculation.
b. Based on Julious SA (32), we will recruit 24 subjects (a sample size of 12 per
group) first, then do an interim analysis and calculate the actual sample size
required for a full RCT. The justifications for this interim sample size are based
on rationale about feasibility, precision about the mean and variance, and
regulatory considerations.
c.
With α at 0.05 and power at 0.8, the final sample size will be calculated based
on the study primary outcome of induction to delivery interval. As this outcome
is a continuous data, we will use the following formula by Snedecor and
Cochran 1989 to calculate the sample size (including 15% of dropout rate).

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s = standard deviation,
d = the difference to be detected, and
C = constant
5. Consent taking:
a.
Pregnant women with one previous Caesarean section who are indicated for
IOL and eligible will be recruited in the study.
b. Participation of the subjects is voluntary and will not affect medical services.
c.
Informed consent available in either English or Malay language (See Appendix
2) will be obtained prior to enrollment into the study.
d. The consent will be taken by the principal investigator at time of admission in
Sibu Hospital Labour Ward.
6. Subject withdrawal:
a.
Criteria:
i. Subjects may withdraw voluntarily from study at any time upon their
request.
ii. Subjects 
are 
inappropriately 
enrolled 
without 
fulfilling
inclusion/exclusion criteria.
iii. Subjects develop spontaneous labour before IOL procedure is
undertaken.
b.
Follow up process:
i. The withdrawn subjects will be managed according to local protocol
under Department O&G, Sibu Hospital.
ii. The withdrawn subjects data will be destroyed as it will not be used for
data analysis.
c.
The withdrawn subjects will be replaced with new subjects in order to meet the
required sample size.

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TREATMENT AND PROCEDURES
1. Treatment and medications that are permitted during the trial:
a.
Amniotomy
b. Oxytocin augmentation when contractions are not optimised
c.
Abdominal and vaginal examination to assess labour progress
d. Intrapartum continuous fetal heart rate monitoring
e.
Fetal scalp sampling in the presence of non-reassuring fetal heart rate
f.
Instrumental delivery or emergency Caesarean section if indicated
2. Both IOL methods of membrane sweeping and transcervical Foley catheter do not
contain drug or medication. Thus, the risk of uterine rupture is similar to spontaneous
labour in women with previous Caesarean delivery. If scar dehiscence is highly
suspected during labour, standard management with recourse to emergency Caesarean
section will be undertaken.
3. Treatment and medications that are not permitted during the trial:
a.
Vaginal prostaglandin E2
ASSESSMENT OF EFFICACY
1. Primary outcome:
a.
Overall induction to delivery interval.
2. Secondary outcomes:
a.
Induction outcomes:
i. Improvement of modified Bishop score at interval of 24 hours and 48
hours after induction.
ii. Whether oxytocin augmentation is required.
b. Delivery outcomes:
i. Mode of delivery.
ii. Duration of oxytocin augmentation overall and in vaginal delivery
group.
iii. Induction to vaginal delivery interval.

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iv. Amniotomy to vaginal delivery interval.
v. Vaginal delivery rate within 24 hours of induction and between 24-48
hours of induction.
c.
Maternal outcomes:
vi. Uterine hyperstimulation (> 5 contractions per 10 minutes for at least 20
minutes or a contraction lasting at least 2 minutes with/without abnormal
fetal heart rate).
vii. Uterine rupture.
viii. Post-partum haemorrhage (estimated blood loss ≥ 500 ml).
ix. Maternal pyrexia  (temperature >38.0 °C once, or 37.5 °C on two
occasions 2 hours apart).
x. Duration of hospitalisation.
d. Neonatal outcomes:
i. APGAR score at 5 minutes.
ii. Cord pH.
ASSESSMENT OF SAFETY
1. No adverse events (AEs) will be expected during the course of study because there is
no involvement of pharmacological drug or product. Both methods of membrane
sweeping and transcervical Foley catheter do not contain drug or medication. Thus, the
risk of uterine rupture is similar to spontaneous labour in women with previous
Caesarean delivery. However, maternal discomfort and vaginal bleeding following
membrane sweeping and unknown latex allergy following transcervical Foley catheter
insertion may occur, and subjects will be informed of this risk in the informed consent.
2. All other invasive (amniotomy, fetal scalp sampling in the presence of non-reassuring
fetal heart rate, instrumental delivery or emergency Caesarean section if indicated) and
non-invasive procedures (maternal vital signs observation and intrapartum continuous
fetal heart rate monitoring) and evaluations (abdominal and vaginal examination to
assess labour progress) included in this protocol  are considered to be standard of care
in evaluation and management of women with one previous Caesarean delivery
undergoing IOL and would have been performed as part of routine practice.

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3. Report of adverse events eg. SAEs, SUSARs.
a.
When adverse event of any type occurs, local SAE/SUSAR report will be
created by principal investigator and notified via SAE Platform on NMRR
website.
b.
Subjects who experience SAE/SUSAR will be followed up by principal
investigator and a follow up report will be submitted.
c.
For “Non-life threatening SUSARs” eg. latex allergy associated with Foley
catheter insertion, vasovagal attack following membrane sweeping, and cervical
tear, initial report is to be submitted within 15 calendar days followed by a
follow up report.
d.
For “Life threatening SUSARs” eg. uterine rupture and maternal sepsis, initial
report is to be submitted within 7 calendar days followed by a follow up report
within the next 8 calendar days.
4. Process and duration of follow-up of adverse events
a.
Latex allergy associated with Foley catheter insertion
i.
Foley catheter will be removed immediately.
ii.
Steroids and anti-histamine will be administered as rescue medication.
iii.
Closed monitoring of vital signs and oxygen saturation for 24 hours.
b.
Vasovagal attack following membrane sweeping
i.
No further membrane sweeping will be performed.
ii.
Affected subject will be withdrawn from the study.
iii.
No rescue medication is needed as condition is self-limiting.
iv.
Closed monitoring of vital signs and oxygen saturation for 24 hours.
c.
Cervical tear
i.
Examination under anaesthesia will be performed immediately.
ii.
Cervical repair will be performed.
iii.
Subject will be followed up till 42 days post-delivery (completion of
puerperal period).
d.
Uterine rupture
i.
Emergency laparotomy will be performed immediately.
ii.
Depend on the severity of uterine rupture, uterine repair or hysterectomy
may be warranted.

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iii.
Subject will be followed up till 42 days post-delivery (completion of
puerperal period).
e.
Maternal sepsis
i.
Blood culture and high vaginal swab for culture will be taken.
ii.
Broad spectrum antibiotics will be started as rescue medication.
iii.
Unstable subjects will be nursed in intensive care unit.
iv.
Subject will be followed up till 42 days post-delivery (completion of
puerperal period).
5. Compensation of adverse events
a.
In the event of a bodily injury or illness directly resulting from the membrane
sweeping or transcervical Foley catheter insertion, the department will pay for
reasonable and necessary treatment.
b.
The department is not responsible for medical expenses due to pre-existing
medical conditions, any underlying diseases, any ongoing treatment process,
subjects’ negligence or willful misconduct, the negligence or willful misconduct
of the investigators or the study site or any third parties.
STATISTICS
1. All results will be analysed using the Statistical Package for Social Sciences for
Windows (SPSS for Windows).
2. Normality of numerical data (Bishop score, induction to delivery interval, induction to
vaginal delivery interval, amniotomy to vaginal delivery interval, duration of oxytocin
augmentation, duration of hospitalisation, APGAR score at 5 minutes, cord pH,
neonatal birth weight) will be assessed using Kolmogorov-Smirnov analysis.
Independent T-test (data with normal distribution) or Mann-Whitney U test (if data not
normally distributed) will be used to compare these outcomes between the group of
membrane sweeping and group of transcervical Foley catheter.
3. Chi-square test will be used to compare:

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a.
The requirement of oxytocin augmentation following induction between the
group of membrane sweeping and group of transcervical Foley catheter.
b. The following delivery outcomes between the group of membrane sweeping and
group of transcervical Foley catheter.
i. Mode of delivery.
ii. Vaginal delivery within 24 hours of induction.
iii. Vaginal delivery within 24-48 hours of induction.
iv. The maternal outcomes (uterine hyperstimulation, uterine rupture, post-
partum haemorrhage, maternal pyrexia) between the group of membrane
sweeping and group of transcervical Foley catheter.
If there is at least one expected value of < 5, Yates correction will be done.
If sample size is less than 20 or (>40 but at least one expected value <5), Fisher test
instead of Chi-square test will be used.
4. Statistical significance is defined as p value < 0.05.
CONFIDENTIALITY AND SECURITY OF SOURCE DOCUMENTS AND STUDY
DATA
1. All of the subjects’ information obtained in this study will be kept and handled in a
confidential manner. When publishing or presenting the study results, subjects’ identity
will not be revealed without their expressed consent.
2. Data from the study will be archived and may be transmitted outside the country for the
purpose of analysis, but subjects’ identity will not be revealed at any time.
3. Following the trial, only the principal and co/sub investigators, and regulatory
authorities but not the subjects have access to study data and findings.
4. Storage and archival of medical records and study data:
a.
Medical records will be kept in the hospital record office as following hospital
policy. The investigators will only keep the study data.

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b. Documents and other study materials can be accessed by staff restricted to the
investigators and regulatory authorities.
c.
All data and documents or study materials will be made available whenever it
is requested by relevant authorities, in the presence of investigator.
d. Duration of study data storage will be 5 years after completion of study. Study
data will be destroyed after period of storage.
FINANCE AND INSURANCE
1. This study is self-funded by Department of O&G, Sibu Hospital.
PUBLICATION POLICY
1. When publishing or presenting the study results, subjects’ identity will not be revealed
without their expressed consent in order to protect subjects’ confidentiality.
2. Data from the study will be archived and may be transmitted outside the country for the
purpose of analysis, but subjects’ identity will not be revealed at any time.
INVOLVEMENT OF VULNERABLE SUBJECTS
1. This study does not involve vulnerable subjects.

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RESULTS (Dummy tables)
Table 1: Demographic characteristics
Characteristics
Membrane
sweeping
Transcervical
Foley catheter
p-value
Age, years
Parity
Gestational age
Ethnicity, n (%)
Iban
Melanau
Bidayuh
Malay
Chinese
Indian
Others
Foreigner
Body mass index, kg/m2
Previous Caesearean section
Tested scar
Untested scar
Indication of induction of labour
Postdate
Fetal growth restriction
Hypertension
Diabetes
Others

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Table 2: Induction outcomes in two groups
Outcomes
Membrane
sweeping
Transcervical
Foley catheter
p-value
Bishop score at start of induction
Bishop score after 24 hours of
induction
Bishop score after 48 hours of
induction
Change in Bishop score
Oxytocin required
Table 3: Delivery outcomes and maternal complications in two group
Outcomes
Membrane
sweeping
Transcervical
Foley
catheter
p-value
Mode of delivery
Vaginal
Caesarean section
Overall
Induction to delivery interval
Oxytocin augmentation duration
Vaginal delivery
Induction to delivery interval
Amniotomy to delivery interval
Oxytocin augmentation duration

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Within 24 hours of induction
Between 24-48 hours of induction
Indication for Caesarean section
Poor progress
Failed induction
Acure fetal distress
Suspected scar dehiscence
Others
Maternal complications
Uterine rupture
Uterine hyperstimulation
Post-partum haemorrhage
Maternal pyrexia
Duration of hospitalisation
Table 4: Neonatal outcomes in two groups
Outcomes
Membrane
sweeping
Transcervical Foley
catheter
p-
value
APGAR score at 5 minutes
Cord pH
Birth weight

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REFERENCES
1. Leduc D, Biringer A, Lee L, Dy J. Induction of labour. Journal of obstetrics and
gynaecology Canada. 2013;35(9):840-57.
2. National Institute for Health and Clinical Excellence. Inducing Labour. NICE CG70.
London: NICE; 2008.
3. Stock SJ, Ferguson E, Duffy A, Ford I, Chalmers J, Norman JE. Outcomes of induction
of labour in women with previous caesarean delivery: a retrospective cohort study using
a population database. PloS one. 2013;8(4):e60404.
4. Talaulikar VS, Arulkumaran S. Failed induction of labor: strategies to improve the
success rates. Obstetrical & Gynecological Survey. 2011;66(11):717-28.
5. Kaczmarczyk M, Sparen P, Terry P, Cnattingius S. Risk factors for uterine rupture and
neonatal consequences of uterine rupture: a population-based study of successive
pregnancies in Sweden. BJOG. 2007;114(10):1208-14.
6. Lydon-Rochelle M, Holt VL, Easterling TR, Martin DP. Risk of uterine rupture during
labor among women with a prior cesarean delivery. New England Journal of Medicine.
2001;345(1):3-8.
7. Mozurkewich EL, Chilimigras JL, Berman DR, Perni UC, Romero VC, King VJ, et al.
Methods of induction of labour: a systematic review. BMC Pregnancy and Childbirth.
2011;11:84-.
8. Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical
methods for induction of labour. The Cochrane Database of Systematic Reviews.
2012(3):Cd001233.
9. Yildirim G, Gungorduk K, Karadag OI, Aslan H, Turhan E, Ceylan Y. Membrane
sweeping to induce labor in low-risk patients at term pregnancy: a randomised
controlled trial. Journal of Maternal-fetal & Neonatal Medicine. 2010;23(7):681-7.
10. de Miranda E, van der Bom JG, Bonsel GJ, Bleker OP, Rosendaal FR. Membrane
sweeping and prevention of post-term pregnancy in low-risk pregnancies: a randomised
controlled trial. BJOG. 2006;113(4):402-8.
11. Foong LC, Vanaja K, Tan G, Chua S. Membrane sweeping in conjunction with labor
induction. Obstetrics and Gynecology. 2000;96(4):539-42.
12. Tan PC, Jacob R, Omar SZ. Membrane sweeping at initiation of formal labor induction:
a randomized controlled trial. Obstetrics and Gynecology. 2006;107(3):569-77.
13. Hamdan M, Sidhu K, Sabir N, Omar SZ, Tan PC. Serial membrane sweeping at term
in planned vaginal birth after cesarean: a randomized controlled trial. Obstetrics and
Gynecology. 2009;114(4):745-51.
14. Ramya V, Ghose S, Pallavee P. Membrane Sweeping for Vaginal Birth after Caesarean
Section and its Outcome -A Comparative Study. Journal of Clinical and Diagnostic
Research. 2015;9(8):QC01-QC3.
15. Boulvain M, Stan C, Irion O. Membrane sweeping for induction of labour. The
Cochrane Database of Systematic Reviews. 2005(1):Cd000451.
16. Rab MT, Mohammed AB, Zahran KA, Hassan MM, Eldeen AR, Ebrahim EM, et al.
Transcervical Foley's catheter versus Cook balloon for cervical ripening in stillbirth
with a scarred uterus: a randomized controlled trial. Journal of Maternal-fetal &
Neonatal Medicine. 2015;28(10):1181-5.
17. Ben-Aroya Z, Hallak M, Segal D, Friger M, Katz M, Mazor M. Ripening of the uterine
cervix in a post-cesarean parturient: prostaglandin E2 versus Foley catheter. Journal of
Maternal-fetal & Neonatal Medicine. 2002;12(1):42-5.

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18. Bujold E, Blackwell SC, Gauthier RJ. Cervical ripening with transcervical foley
catheter and the risk of uterine rupture. Obstetrics and Gynecology. 2004;103(1):18-23.
19. Jozwiak M, van de Lest HA, Burger NB, Dijksterhuis MG, De Leeuw JW. Cervical
ripening with Foley catheter for induction of labor after cesarean section: a cohort
study. Acta Obstet Gynecol Scand. 2014;93(3):296-301.
20. Lamourdedieu C, Gnisci A, Marcelli M, Heckenroth H, Gamerre M, Agostini A.
Cervical ripening after previous cesarean section with Foley catheter: A prospective
study of 41 patients. J Gynecol Obstet Biol Reprod (Paris). 2015;44(5):426-32.
21. Ravasia DJ, Wood SL, Pollard JK. Uterine rupture during induced trial of labor among
women with previous cesarean delivery. American Journal of Obstetrics and
Gynecology. 2000;183(5):1176-9.
22. Sananes N, Rodriguez M, Stora C, Pinton A, Fritz G, Gaudineau A, et al. Efficacy and
safety of labour induction in patients with a single previous caesarean section: a
proposal for a clinical protocol. Archives of Gynecology and Obstetrics.
2014;290(4):669-76.
23. Sarreau M, Leufflen L, Monceau E, Tariel D, Villemonteix P, Morel O, et al. Balloon
catheter for cervical ripening on scarred uterus with unfavorable cervix: multicenter
retrospective study of 151 patients. J Gynecol Obstet Biol Reprod (Paris).
2014;43(1):46-55.
24. Ziyauddin F, Hakim S, Beriwal S. The transcervical foley catheter versus the vaginal
prostaglandin e2 gel in the induction of labour in a previous one caesarean section - a
clinical study. Journal of Clinical and Diagnostic Research. 2013;7(1):140-3.
25. Gonsalves H, Al-Riyami N, Al-Dughaishi T, Gowri V, Al-Azri M, Salahuddin A. Use
of Intracervical Foley Catheter for Induction of Labour in Cases of Previous Caesarean
Section: Experience of a single tertiary centre in Oman. Sultan Qaboos University
Medical Journal. 2016;16(4):e445-e50.
26. Meetei L, Suri V, Aggarwal N. Induction of labor in patients with previous cesarean
section with unfavorable cervix. Journal of Medical Society. 2014;28(1):29-33.
27. Heinemann J, Gillen G, Sanchez-Ramos L, Kaunitz AM. Do mechanical methods of
cervical ripening increase infectious morbidity? A systematic review. American Journal
of Obstetrics and Gynecology. 2008;199(2):177-87.
28. Jozwiak M, Oude Rengerink K, Benthem M, van Beek E, Dijksterhuis MG, de Graaf
IM, et al. Foley catheter versus vaginal prostaglandin E2 gel for induction of labour at
term (PROBAAT trial): an open-label, randomised controlled trial. Lancet.
2011;378(9809):2095-103.
29. Kehl S, Ehard A, Berlit S, Spaich S, Sutterlin M, Siemer J. Combination of misoprostol
and mechanical dilation for induction of labour: a randomized controlled trial.
European Journal of Obstetrics, Gynecology, and Reproductive Biology.
2011;159(2):315-9.
30. Mackeen AD, Walker L, Ruhstaller K, Schuster M, Sciscione A. Foley catheter vs
prostaglandin as ripening agent in pregnant women with premature rupture of
membranes. The Journal of the American Osteopathic Association. 2014;114(9):686-
92.
31. Maslovitz S, Lessing JB, Many A. Complications of trans-cervical Foley catheter for
labor induction among 1,083 women. Archives of Gynecology and Obstetrics.
2010;281(3):473-7.
32. Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat.
2005;4(4):287-91.

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Study Procedure Flow Chart
Maternal and neonatal outcomes
both arms are compared
Subjects randomised to
membrane sweeping
Subjects undergo membrane
sweeping on the next day
Delivery
Women with one previous Caesarean delivery who are
planned for induction of labour (IOL)
Study explanation, consent, recruitment into
study if agreeable
Subjects randomised to
transcervical Foley catheter.
Appendix 1
Subjects will have transcervical Foley
catheter insertion on the next day

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PATIENT INFORMATION SHEET AND INFORMED CONSENT FORM
1. Title of study:
Membrane Sweeping versus Transcervical Foley Catheter for Induction of Labour in
Women with Previous Caesarean Delivery
2. Name of investigator and institution:
Dr. Yong Soon Leong
Dr. Joyce Ting Chin Sing
Dr. Ling Tin Yee
Organisations / Institutes:
Department of Obstetrics & Gynaecology, Sibu Hospital.
3. Name of sponsor:
This research is self-funded by Department of O&G, Sibu Hospital.
4. Introduction:
You are invited to participate in a research study because you will be undergoing an
induction of labour (artificial initiation of labor). The details of the research trial are
described in this document. Please read through and consider this information carefully
before you decide if you are willing to participate. Ask the study staff if anything is
unclear or if you like more information. After you are properly satisfied that you
understand this study, and that you wish to participate, you must sign this informed
consent form.
Your participation in this study is voluntary. If you volunteer to be in this study, you
may withdraw from it at any time. Your refusal to participate or withdrawal will not
affect any medical or health benefits to which you are otherwise entitled.
This study has been approved by the Medical Research and Ethics Committee, Ministry
of Health Malaysia.
5. What is the purpose of the study?
Nowadays, more and more women embark on pregnancy with previous Caesarean scar.
One in five pregnancies requires induction of labour. The use of non-pharmacological
methods (methods without using medication) has been gaining popularity for women
who are not good candidates, such as women with previous Caesarean scar, for an
induction with medications such as prostaglandin. Labour induction with prostaglandin
carries higher risk of uterine rupture and thus it is not routinely offered to women with
previous Caesarean delivery in Sibu Hospital. Non-pharmacoloical methods of
induction of labour appear to be safe in women with previous Caesarean delivery.
However, various methods are available and the efficacy among them remain in doubt.
In Sibu Hospital, membrane sweeping, which is a type of non-pharmacological method,
is routinely offered to women with previous Caesarean delivery who require induction
of labour. However, membrane sweeping may not exert its labour induction effect
immediately and the delivery may be delayed by up to 8 days. This may render a
proportion of women to resort to repeated Caesarean section for failed induction.
Appendix 2

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Transcervical Foley catheter insertion is another non-pharmacological methods for
labour induction. Foley catheter, which is made from latex rubber, is inserted into the
womb. The balloon will be inflated and this puts pressure on the cervix and encourages
dilatation. This method may successfully stimulates labour and the catheter falls out
once the cervix dilates to 3 centimeters.
The benefits of the Foley catheter:

A favourable and safe option for mothers who are hoping for a vaginal birth after
Caesarean. It is estimated that 4-7 in 10 women with previous Caesarean
undergoing labour induction with Foley catheter will have successful vaginal births.

Cause the cervix to mechanically open without involving medication.

Reduced risk of uterine rupture compared to induction with prostaglandin.

Less risk of fetal distress compared to induction with prostaglandin.
The risks of Foley catheter:

Vaginal bleeding (1.8%)

Pain requiring removal of catheter (1.7%)

Baby moving from head down to breech (1.3%)

Fever (1%) which is lower than induction with prostaglandin.

The risk of uterine rupture is similar to women undergoing spontaneous vaginal
birth after Caesarean.
The aim of this study is to compare the effectiveness of two types of non-
pharmacological methods, ie. membrane sweeping and transcervical Foley catheter for
induction of labour in women with previous Caesarean delivery. As there was no
previous study comparing the two methods, the actual number of subjects like you to
participate in this study is yet to be decided. Thus, there will be initial 24 subjects like
you participating in this study. Subsequently, the interim analysis will be conducted to
decide the actual number of subjects required for this study.
6. What kind of study products will I receive?
You will be randomly (by chance, like flipping a coin) assigned to one of the treatment
groups below. You have equal chance of being assigned to each of the groups.
Group 1: Induction of labour with membrane sweeping
Group 2: Induction of labour with transcervical Foley catheter
Membrane sweeping involves placing a finger into the neck of the womb and making
circular, sweeping movement to separate the membranes that surround the baby, or
massaging the neck of the womb if this is not possible. Membrane sweeping will be
performed twice a day.
Transcervical Foley catheter involves placing a latex rubber balloon catheter into the womb
and the balloon near the tip of the catheter will be inflated with 60 ml of water. The catheter
will be kept for 24 hours. If it were expelled by itself, it will not be re-inserted.
7. What will I need to do if I decide to take part?

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On the next day of admission, you will undergo induction of labour with either
membrane sweeping or transcervical Foley catheter depends on randomised allocation.
Following that, your labour contraction will be monitored every 4 hour. Your baby heart
rate will be checked as well.
After 24 hours, amniotomy (artificially break the waters) will be performed. If it is not
possible, membrane sweeping will be continued for one more day in Group 1 whereas
conservative management will be undertaken for one day in Group 1. Suitability for
amniotomy will be reassessed on the next day.
Following amniotomy, you will undergo labour as usual. Oxytocin (a drug which is used
to augment the labour progress) will be given following hospital protocol if contractions
are not adequate.
If amniotomy is still impossible after 2 days of effort, your obstetrician will discuss further
management with you and you may be offered option of Caesarean section.
The study endpoints are duration from labour induction to delivery and final mode of
delivery (whether vaginal birth or Caesarean delivery). We will observe the outcome
of your delivery and your baby. Your expected duration of study participation will be
from labour induction until you have delivered your baby. All the outcomes will be
recorded into study clinical report form.
8. When will I receive the trial product?
Induction of labour with either membrane sweeping or transcervical Foley catheter will
be carried out on the next day of admission.
9. What are the potential risks and side effects of being in this study?
Both membrane sweeping or transcervical Foley catheter insertion may cause pain and
vaginal bleeding. As both methods do not contain drug or medication. Thus, the risk of
uterine rupture is similar to natural labour in women with previous Caesarean delivery.
You may develop fever after Foley catheter insertion but risk of severe infection has
been reported unlikely. Otherwise, there will be no other major risk or side effect of
being in this study. Participant with known allergy to latex will be excluded from this
study.
Both membrane sweeping and transcervical Foley catheter will have no effect on an
unborn child.
Please ask your study doctor if you need more information on risks and side effects.
10. What are the benefits of being in this study?
There may or may not be any benefit to you. Information obtained from this study will
help to identify the most suitable method for induction of labour to be offered to women
with previous Caesarean delivery in this hospital. At this moment, transcervical Foley
catheter is not a routine practice in our hospital. But, membrane sweeping is routinely
offered to women with previous Caesarean delivery requiring induction of labour.
11. What if I am injured during this study?
If you are injured as a result of being in this study, you should contact your study doctor.
In the event of a bodily injury or illness directly resulting from the study product or a

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medical procedure required for this study, the department will pay for reasonable and
necessary treatment. The department is not responsible for medical expenses due to pre-
existing medical conditions, any underlying diseases, any ongoing treatment process,
your negligence or willful misconduct, the negligence or willful misconduct of your
study doctor or the study site or any third parties. You do not lose any of your legal
rights to seek compensation by signing this form.
12. Do I have to pay for the study product?
You do not have to pay for participating in this study. Similarly, no payment is available
for you for participating in this study. All other drugs, medical procedure, or delivery
that are not required by the study but are part of your routine medical care will have to
be paid by you or your insurance.
13. Can the research or my participation be terminated early?
The study doctor may due to concerns for your safety, stop the study or your
participation at any time. If the study is stopped early for any reason, you will be
informed and arrangements made for your future care. You may be asked to attend a
final follow-up visit.
14. Will my medical information be kept private?
All your information obtained in this study will be kept by the principal investigators
and handled in a confidential manner, in accordance with applicable laws and/or
regulations. When publishing or presenting the study results, your identity will not be
revealed without your expressed consent.
Data from the study will be archived and may be transmitted outside the country for the
purpose of analysis, but your identity will not be revealed at any time.
The medical records, study data and findings can be accessed by staff restricted to the
investigators and regulatory authorities but not the participants.
Your will not be informed regarding the study findings as the result will not affect your
care of management.
15. Who should I call if I have questions?
If you have any questions about the study, and you want information about intervention,
please contact the study doctors, Dr. Yong Soon Leong at telephone number 017-
9197139 or Dr. Joyce Ting Chin Sing at telephone number 016-8948123.
We shall inform you if there is new information becomes available relevant to consent.
If you have any questions about your rights as a participant in this study, please contact:
The Secretary, Medical Research & Ethics Committee, Ministry of Health Malaysia, at
telephone number 03-2287 4032.

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INFORMED CONSENT FORM
Title of Study:
Membrane Sweeping versus Transcervical Foley Catheter for Induction of Labour in
Women with Previous Caesarean Delivery
By signing below I confirm the following:
I have been given oral and written information for the above study and have read and
understood the information given.
I have had sufficient time to consider participation in the study and have had the
opportunity to ask questions and all my questions have been answered satisfactorily.
I understand that my participation is voluntary and I can at anytime free withdraw from
the study without giving a reason and this will in no way affect my future treatment. I
am not taking part in any other research study at this time. I understand the risks and
benefits, and I *agree / disagree(*delete which is not applicable) to participate in the
study as stated above.
I understand that I must follow the study doctor’s (investigator’s) instructions related
to my participation in the study.
I understand that study staff, and governmental or regulatory authorities, have direct
access to my medical record in order to make sure that the study is conducted correctly
and the data are recorded correctly. All personal details will be treated as STRICTLY
CONFIDENTIAL.
I will receive a copy of this subject information/informed consent form signed and dated
to bring home.
Subject:
Signature:
I/C number:
Name:
Date:
Investigator conducting informed consent:
Signature:
I/C number:
Name:
Date:
Impartial witness:(Required if subject is illiterate and contents of patient information sheet is
orally communicated to subject)
Signature:
I/C number:
Name:
Date:

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DEPARTMENT OF O&G, SIBU HOSPITAL, SARAWAK
DATA COLLECTION FORM
MEMBRANE SWEEPING VERSUS TRANSCERVICAL FOLEY CATHETER
FOR INDUCTION OF LABOUR IN WOMEN WITH PREVIOUS
CAESAREAN DELIVERY
Patient ID
: .........................................................
Name
: ............................................................. Date/time of admission: ……………………………
IC Number
: ............................................................. Date/time of discharge : ……………………………
MRN
: .............................................................
Age
: .............................................................
Ethnicity
:
Iban
Melanau
Bidayuh
Malay
Chinese
Indian
Other
Foreigner
ALLOCATED GROUP: (PLEASE TICK)
MEMBRANE SWEEPING
TRANSCERVICAL FOLEY CATHETER
Appendix 3

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SECTION A: DEMOGRAPHIC INFORMATION
Gravida / Parity: …………./……………
Gestational age at induction of labour: …….. weeks ……. days
EDD/REDD: ………………………………..
Height (m): ……………………..
Weight (kg): ……………… (at booking) ……………… (at delivery)
BMI (kg/m2): ………………………
Previous Caesarean section: (please tick)
a)
Untested scar
If untested scar, any
previous vaginal delivery?
Yes
b)
Tested scar
No
Indication of induction of labour: (please tick)
a)
Postdate
b)
Fetal growth restriction
c)
Hypertension
d)
Diabetes
e)
Other
Please specify: ………………………………………
SECTION B: INDUCTION OUTCOMES **Modified Bishop score is used in this study
Modified Bishop score:
a)
At the start of induction
b)
When Foley catherter dislodged < 24 hours
(only applicable to Foley group)
a)
After 24 hours of induction
b)
After 48 hours of induction
Achieved favourable Bishop (≥ 8) score: (please tick)
Yes
No
(if yes, proceed to sub-question;
If no, proceed to next question)
a)
Interval to achieve favourable Bishop score
(hours)
Achieved cervix allowing amniotomy: (please tick)
Yes
No
(if yes, proceed to sub-question;
If no, proceed to next section)
a)
Bishop score at that time
b)
Os dilatation at that time
(cm)
c)
Cervical length at that time
(cm)

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SECTION C: DELIVERY OUTCOMES
Oxytocin required during delivery (please tick)
Yes
No
Mode of delivery: (please tick)
Vaginally
Within 24  /  24-48 / > 48 hours of induction (please circle)
Instrumentation
Vacuum  /  forceps (please circle)
Indication:
Caesarean section
Indication:
Durations (regardless of final mode of delivery):
a)
Induction to delivery
(hours)
b)
Oxytocin augmentation
(minutes)
Durations (only for vaginal delivery including instrumental delivery):
a)
Induction to vaginal delivery
(hours)
b)
Amniotomy to vaginal delivery
(hours)
c)
Oxytocin augmentation
(minutes)
Estimated blood loss (EBL): …………………. ml
If EBL > 500ml, please mention cause: (please tick)
a)
Uterine atony
b)
Perineal trauma
c)
Retained placenta
d)
Coagulopathy
e)
Others
Please specify: …………………………………………..
Maternal complications: (please tick)
a)
Uterine rupture
Yes
No
b)
Uterine hyperstimulation
Yes
No
c)
Post-partum haemorrhage
Yes
No
d)
Maternal pyrexia
Yes
No

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Neonatal outcomes:
a)
APGAR score at 5 minutes
To:  NICU  /  SCN  /  mother (please circle)
b)
Cord pH
c)
Birth weight
SECTION D: MATERNAL SATISFACTION
If you had to repeat it all over again, would you take part in the study? (please tick)
Yes
No
If no, please provide reason(s).
______________________________
Notes:
Uterine hyperstimulation
:
> 5 contractions per 10 minutes for at least 20 minutes or a contraction
lasting at least 2 minutes with/without abnormal fetal heart rate
Post-partum haemorrhage
:
Estimated blood loss ≥ 500 ml
Maternal pyrexia
:
Temperature >38.0 °C once, or 37.5 °C on two occasions 2 hours apart