Postpartum Hemorrhage
Conditions
Keywords
Misoprostol, Active management, Postpartum hemorrhage, Maternal morbidity, Anemia, Developing countries
Brief summary
This hospital-based, multicenter, randomized, placebo-controlled trial will assess the effects of misoprostol as part of active management of the third stage of labor on postpartum blood loss, complications, and side effects. Twelve hundred eligible women will receive routine oxytocics (oxytocin 5-10 IU) plus either 400 mcg sublingual misoprostol or placebo during or immediately after delivery. The primary outcome will be measured blood loss of =\>500 mls within one hour after enrollment.
Interventions
DRUGmisoprostol
DRUGplacebo
placebo resembling misoprosotl
Sponsors
University of Witwatersrand, South Africa
Effective Care Research Unit
Family Care International
Gynuity Health Projects
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Women who have given birth to 1 or more live-born infants (para 1 or more) * Vaginal delivery
Exclusion criteria
* Refusal or inability to give informed consent * Delivery regarded as abortion according to local gestational age limits * Inability to take misoprostol sublingually * Cesarean section * Assisted vaginal delivery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood loss =>500 mls within one hour after enrollment | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood loss =>1000 mls within one hour after enrollment | — |
| Mean blood loss after enrollment | — |
| Blood transfusion | — |
| Hemoglobin level <8 g/dL 24 hours after delivery | — |
| Maternal morbidity and mortality | — |
| Side effects | — |
Countries
Nigeria, South Africa, Uganda
Outcome results
None listed