Serial Membrane Sweeping at term in planned Vaginal Birth After Caesarean
| ISRCTN | ISRCTN55163179 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55163179 |
| Secondary identifying numbers | 601.12 |
- 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
Not provided at time of registration
Contact information
Prof Peng Chiong Tan
Scientific
Scientific
Department of Obstetrics and Gynaecology
Faculty of Medicine
University of Malaya
Lembah Pantai
Kuala Lumpur
50603
Malaysia
| Phone | +60 (0)3 7949 2059 |
|---|---|
| pctan@um.edu.my |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 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(s) | University of Malaya Medical Centre Medical Ethics Committee gave approval on the 25th July 2007 (ref: 601.12) |
| 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 |
| Primary outcome measure | 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 study start date | 07/09/2007 |
| Overall study end date | 06/11/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | At least 211 |
| 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 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
Study participating centre
Department of Obstetrics and Gynaecology
Kuala Lumpur
50603
Malaysia
50603
Malaysia
Sponsor information
University of Malaya (Malaysia)
University/education
University/education
Lembah Pantai
Kuala Lumpur
50603
Malaysia
| Website | http://www.um.edu.my/ |
|---|---|
"ROR" |
https://ror.org/00rzspn62 |
Funders
Funder type
University/education
University of Malaya (Malaysia)
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Malaya, University Malaya, Malayan University, UM
- Location
- Malaysia
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2009 | Yes | No |
