Misoprostol to treat Postpartum Haemorrhage (PPH): a randomised controlled trial (Argentina, Egypt, South Africa, Thailand and Viet Nam)
| ISRCTN | ISRCTN34455240 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34455240 |
| Protocol serial number | WHO/A35042 |
| Sponsor | UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction |
| Funders | United Nations Development Programme (UNDP)/United Nations Population Fund (UNFPA)/World Health Organization (WHO)/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Gynuity Health Projects will be responsible for funding and financial oversight of the centres |
- Submission date
- 06/06/2005
- Registration date
- 07/06/2005
- Last edited
- 25/08/2011
- 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 J Villar
Scientific
Scientific
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| villarj@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To assess the effects of misoprostol adjunct to the use of injectable oxytocics in women requiring additional uterotonics following active management of the third stage of labour, on outcomes such as blood loss and side effects. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Postpartum haemorrhage |
| Intervention | Women will be provided with information about the trial during antenatal care. At admission for delivery the trial will be explained again and women will be invited to give informed consent. After delivery, women clinically diagnosed with postpartum haemorrhage requiring further uterotonic treatment will be given injectable uterotonics as routinely practised at each centre. Women with PPH who agreed to participate in the trial will be randomized and will be given the trial's treatment (3 tablets of misoprostol 200 µg or placebo). The three tablets will be administered sublingually. The administration of the study medication (misoprostol or placebo) will be as close to the administration of additional injectable uterotonics as possible. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Misoprostol |
| Primary outcome measure(s) |
The primary outcome will be the incidence of greater than or equal to 500 ml of measured blood loss at 60 minutes after enrolment. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 1400 |
| Key inclusion criteria | All women delivering vaginally with clinically diagnosed PPH thought to be due to or contributed to by atonia requiring additional uterotonics will receive either misoprostol or placebo in addition to routine treatment for PPH. |
| Key exclusion criteria | Refusal to give consent for participation; Too ill or distressed to give consent; The woman is not entitled to give informed consent e.g. minors without a guardian; The delivery is regarded as abortion according to the local gestational age limits; If the woman is delivered by caesarean section; If the woman cannot take misoprostol sub-lingually; If the woman suffers from severe bleeding disorder such as haemophilia; If the woman has a temperature of more than 38.5°C; If the woman has any severe allergic condition; If the woman's placenta is not delivered at the time of randomization. |
| Date of first enrolment | 01/05/2005 |
| Date of final enrolment | 31/10/2006 |
Locations
Countries of recruitment
- Argentina
- Egypt
- South Africa
- Switzerland
- Thailand
- Viet Nam
Study participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
CH-1211
Switzerland
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 | 22/05/2010 | Yes | No |
