Misoprostol for treating postpartum haemorrhage: a randomised controlled trial
| ISRCTN | ISRCTN72263357 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72263357 |
| Secondary identifying numbers | CRHS010215a |
- Submission date
- 19/07/2004
- Registration date
- 20/07/2004
- Last edited
- 10/08/2007
- 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 G Justus Hofmeyr
Scientific
Scientific
P Bag X9047
East London
5201
South Africa
| Phone | +27 (0)832809402 |
|---|---|
| gjh@global.co.za |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Screening |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Postpartum haemorrhage |
| Intervention | 1. Intervention group: Misoprostol 200 µg tablets. Each woman receives 1 tablet orally, 2 tablets sublingually and 2 tablets rectally. 2. Control group: identical placebo tablets. Each woman receives 1 tablet orally, 2 tablets sublingually and 2 tablets rectally. (All women receive routine accepted treatment for postpartum haemorrhage) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Misoprostol |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2002 |
| Completion date | 01/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Women with postpartum haemorrhage defined as vaginal bleeding after childbirth considered to be excessive, and considered likely to be due to inadequate uterine contraction |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 01/12/2003 |
Locations
Countries of recruitment
- South Africa
Study participating centre
P Bag X9047
East London
5201
South Africa
5201
South Africa
Sponsor information
University of the Witwatersrand (South Africa)
University/education
University/education
7, York Rd
Parktown
Johannesburg
2193
South Africa
| Phone | +27 (0)11 717 2000 |
|---|---|
| gjh@global.co.za | |
"ROR" |
https://ror.org/03rp50x72 |
Funders
Funder type
University/education
University of the Witwatersrand (South Africa) - No external funding; this trial was funded from the existing research unit budget, using full-time research staff.
No information available
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 | 06/08/2004 | Yes | No |
