Rectal misoprostol in the prevention of postpartum hemorrhage: A placebo-controlled trial

OBJECTIVE: This study investigated the effectiveness of rectal misoprostol in preventing postpartum hemorrhage. STUDY DESIGN: In a randomized, placebo-controlled study, 550 women were randomly allocated to rectally receive 400 mu g misoprostol or nonidentical placebo after normal vaginal delivery. Any excessive bleeding was actively managed with conventional oxytocic agents. Blood loss was measured directly. RESULTS: The baseline variables were similar. Blood loss of greater than or equal to 1000 mL occurred in 4.8% (13/270) of the misoprostol group and 7% (19/272) of the placebo group. Additional oxytocic therapy was required by 3.3% and 4.7%, respectively. No predominance of side effects, particularly shivering, was noted in the misoprostol group. CONCLUSIONS: Postpartum use of 400 mu g rectal misoprostol was well tolerated and associated with a statistically nonsignificant trend toward less postpartum hemorrhage. The early active management of excessive bleeding with conventional oxytocic agents may have reduced the potential of the study to detect differences between the groups.