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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,200
placebo resembling misoprosotl
University College Hospital
Ibadan, Nigeria
Tembisa Hospital
Johannesburg, South Africa
Rob Ferreira Hospital
Mbombela, South Africa
Dora Nginza Hospital
Port Elizabeth, South Africa
Mulago Hospital
Blood loss =>500 mls within one hour after enrollment
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
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Kampala, Uganda