Serial Membrane Sweeping at term in planned Vaginal Birth After Caesarean

ISRCTN	ISRCTN55163179
DOI	https://doi.org/10.1186/ISRCTN55163179
Protocol serial number	601.12
Sponsor	University of Malaya (Malaysia)
Funder	University of Malaya (Malaysia)

Submission date: 12/05/2009
Registration date: 13/05/2009
Last edited: 16/11/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Peng Chiong Tan
Scientific

Department of Obstetrics and Gynaecology
Faculty of Medicine
University of Malaya
Lembah Pantai
Kuala Lumpur
50603
Malaysia

Phone	+60 (0)3 7949 2059
Email	pctan@um.edu.my

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Serial weekly membrane sweeping at term in women who planned vaginal birth after one caesarean delivery: a randomised trial
Study acronym	SMS_VBAC Trial
Study objectives	That serial weekly stretching of the cervix and stripping of the membrane from the lower segment of the uterus at term will facilitate the onset of spontaneous labour.
Ethics approval(s)	University of Malaya Medical Centre Medical Ethics Committee gave approval on the 25th July 2007 (ref: 601.12)
Health condition(s) or problem(s) studied	Planned vaginal birth after caesarean
Intervention	Weekly cervical stretching and membrane stripping (membrane sweeping) from greater than 36 weeks gestation versus weekly gentle vaginal examination (control). Random allocation to membrane sweeping or gentle vaginal examination. Allocated treatment conducted as an outpatient procedure in the antenatal clinic. The treatment continues on a weekly basis until delivery has occurred. Standard management of pegnancy and delivery applies.
Intervention type	Other
Primary outcome measure(s)	Spontaneous labour, defined as: 1. Regular painful contractions that had resulted in at least 3 cm of cervical dilation, or 2. Confirmed pre-labour rupture of membranes
Key secondary outcome measure(s)	1. Caesarean delivery 2. Formal labour induction 3. Recruitment to delivery interval 4. Gestational age at delivery 5. Number of membrane sweep or control sessions conducted 6. Bishop score at each session 7. Unscheduled hospitalisation 8. Significant antepartum haemorrhage 9. Prostaglandin and oxytocin use 10. Duration of hospitalisation at birth 11. Epidural analgesia 12. Neonatal outcomes of umbilical artery blood pH, Apgar score at 5 minutes and birth weight All obtained by the time of discharge from hospital after birth, i.e., no later than 6 weeks after enrolment.
Completion date	06/11/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	211
Key inclusion criteria	Pregnant women with the following characteristics: 1. One previous transverse lower segment caesarean scar 2. Singleton pregnancy 3. Foetus in cephalic presentation 4. Intact membranes 5. Gestational age greater than 36 week 6. Agreed to a trial of vaginal birth 7. Passed physician screening for a trial of vaginal birth
Key exclusion criteria	Otherwise eligible women with the following are excluded: 1. Placenta praevia 2. Suspected foetal macrosomia 3. Suspected cephalopelvic disproportion 4. Abnormal foetal lie 5. Obstructive pelvic masses
Date of first enrolment	07/09/2007
Date of final enrolment	06/11/2008

Locations

Countries of recruitment

Malaysia

Study participating centre

Department of Obstetrics and Gynaecology

Kuala Lumpur
50603
Malaysia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes