A double-blind randomized controlled clinical trial of oral misoprostol versus ergometrine in the prevention of primary postpartum hemorrhage

Abstract

Objective: The study was designed to investigate the effectiveness of orally administered misoprostol versus intravenous ergometrine (stored at tropical temperatures) in the prevention of primary postpartum hemorrhage (PPH) among parturients undergoing vaginal delivery in a teaching hospital. Study Design: A double-blind randomized controlled clinical trial was conducted at the University of Benin Teaching Hospital. One hundred and fifty parturients were offered 400 ug misoprostol and an intravenous placebo for the management of the third stage of labor while another 150 parturients received oral placebo and 0.5 mg intravenous ergometrine. Results: There was no significant difference in the incidence of PPH (blood loss > 500 ml) between the two groups: 8 (5.3%) for the misoprostol group compared with 7 (4.7%) for the ergometrine group (P = 0.79, relative risk (RR) = 1.07, confidence interval (CI): 0.66–1.74). The incidence of severe PPH (blood loss > 1000 ml) was similar between the two groups: 2 (1.3%) in the misoprostol group compared with 1 (0.7%) in the ergometrine group. Similarly, the indices of postpartum blood loss (hematocrit change, need for blood transfusion, and surgical intervention) were comparable between the two groups. A subgroup analysis of high-risk parturients revealed comparable indices. The misoprostol group, however, had a significantly higher risk of shivering in the early postpartum period (P = 0.00, RR = 2.01, CI: 1.69–2.38). Conclusions: The results suggest that oral misoprostol has comparable efficacy to intravenous ergometrine at tropical conditions in the prevention of PPH. However, in view of its easier mode of administration, oral misoprostol may be preferable in rural situations in Africa.