Comparison of oral misoprostol with vaginal prostin for induction of labour at term with prolonged rupture of membranes
| ISRCTN | ISRCTN57744215 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57744215 |
| Protocol serial number | N0024125766 |
| Sponsor | Department of Health |
| Funder | Homerton University Hospital NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 10/11/2010
- 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
Dr Katrina Erskine
Scientific
Scientific
Department of Obstetrics & Gynaecology
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom
| Phone | +44 (0)20 8510 7208 |
|---|---|
| katrina.erskine@homerton.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 1. Is oral misoprostol as safe and effective as vaginal prostin? 2. Is patient satisfaction improved with oral misoprostol? 3. Is there a reduction in caesarean section rate with oral misoprostol? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pregnancy and Childbirth: Labour induction |
| Intervention | Randomised controlled trial 1. Misoprostol 2. Prostin |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Time of induction to delivery time |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 200 |
| Key inclusion criteria | 200 women with term rupture of membranes fitting our inclusion criteria randomised to receive prostin or misoprostol |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/04/2003 |
| Date of final enrolment | 31/03/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Obstetrics & Gynaecology
London
E9 6SR
United Kingdom
E9 6SR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/04/2008 | Yes | No |
