Condition category
Pregnancy and Childbirth
Date applied
12/05/2009
Date assigned
13/05/2009
Last edited
16/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Peng Chiong Tan

ORCID ID

Contact details

Department of Obstetrics and Gynaecology
Faculty of Medicine
University of Malaya
Lembah Pantai
Kuala Lumpur
50603
Malaysia
+60 (0)3 7949 2059
pctan@um.edu.my

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

601.12

Study information

Scientific title

Serial weekly membrane sweeping at term in women who planned vaginal birth after one caesarean delivery: a randomised trial

Acronym

SMS_VBAC Trial

Study hypothesis

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

University of Malaya Medical Centre Medical Ethics Committee gave approval on the 25th July 2007 (ref: 601.12)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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.

Overall trial start date

07/09/2007

Overall trial end date

06/11/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

At least 211

Participant 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

Recruitment start date

07/09/2007

Recruitment end date

06/11/2008

Locations

Countries of recruitment

Malaysia

Trial participating centre

Department of Obstetrics and Gynaecology
Kuala Lumpur
50603
Malaysia

Sponsor information

Organisation

University of Malaya (Malaysia)

Sponsor details

Lembah Pantai
Kuala Lumpur
50603
Malaysia

Sponsor type

University/education

Website

http://www.um.edu.my/

Funders

Funder type

University/education

Funder name

University of Malaya (Malaysia)

Alternative name(s)

University of Malaya, UM

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Malaysia

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19888030

Publication citations

  1. Results

    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., Obstet Gynecol, 2009, 114, 4, 745-751, doi: 10.1097/AOG.0b013e3181b8fa00.

Additional files

Editorial Notes