Randomized controlled trial comparing 200µg and 400µg sublingual misoprostol for prevention of primary postpartum hemorrhage.

ABSTRACT

OBJECTIVE: To compare efficacy and adverse effects of 200µg and 400µg misoprostol for prevention of postpartum hemorrhage (PPH). METHODS: In a randomized control trial, women with term singleton pregnancies in active labor attending University College Hospital, Ibadan, Nigeria, were enrolled between July 2011 and February 2012. Participants were randomly assigned using random numbers (block size four) to receive 200µg or 400µg sublingual misoprostol after delivery of the anterior shoulder, alongside intravenous oxytocin. Investigators were masked to group assignment, but participants were not. The primary outcomes were blood loss up to 1h after delivery, PPH (blood loss ≥500mL), and adverse effects. RESULTS: Overall, 62 patients were assigned to each group. No significant differences between the 200-µg and 400-µg groups were recorded in mean peripartum blood loss (307±145mL vs 296±151mL; P=0.679) and PPH occurrence (5 [8.1%] vs 6 [9.7%] women; P=0.752). Noticeable adverse effects were reported by 16 (25.8%) women in the 200-µg group and 42 (67.7%) in the 400-µg group (P<0.001). Risk of shivering was significantly lower with 200µg than 400µg (relative risk 0.33, 95% confidence interval 0.19-0.58). CONCLUSION: Blood loss and PPH occurrence did not differ by misoprostol dose, but a 200-µg dose was associated with a reduction in adverse effects. Pan Africa Clinical Trials Registry PACTR201505001107182.