Postpartum haemorrhage Pregnancy and Childbirth Postpartum haemorrhage
Conditions
Interventions
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 del
Sponsors
UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
Eligibility
Sex/Gender
Female
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the incidence of greater than or equal to 500 ml of measured blood loss at 60 minutes after enrolment. Follow up duration for primary endpoints: approximate duration of involvement in the study for each subject is one follow up visit 10 days post-treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Argentina, Egypt, South Africa, Thailand, Viet Nam
Outcome results
None listed