A randomized controlled trial of sublingual misoprostol and intramuscular oxytocin for prevention of postpartum hemorrhage

Abstract

Purpose: In India, two third of maternal deaths occur in rural areas where there is lack of transportation facilities, lack of refrigeration to store the injectable uterotonic drug such as oxytocin, lack of skilled personnel to administer them and lack of sterile syringes and needles. Hence, this study was conceived to evaluate misoprostol as a safe, effective, easily administered non-parenteral drug in the prevention of postpartum hemorrhage.

Methods: This study was conducted during the period from August 2012 to July 2014. Low risk women with singleton pregnancy at term admitted for vaginal delivery were eligible for the study. A total of 500 women were randomized to two groups, 250 in each group, either to receive 400 mcg misoprostol sublingually or 10 units oxytocin intramuscularly at the delivery of anterior shoulder. Patient factors, labor parameters, blood loss and side effects were noted.

Results: The women in both the groups were well matched with respect to age, parity, gestational age and labor parameters. There was statistical significance in the blood loss (p = 0.04) between the two groups. The average blood loss was 70 ml in misoprostol group and 75 ml in oxytocin group. Shivering was the statistically significant side effect (p = 0.004) in the misoprostol group and nausea was the statistically significant side effect (p = 0.003) in the oxytocin group.

Conclusions: Sublingual misoprostol is as effective as intramuscular oxytocin as a prophylactic oxytocic in the active management of third stage of labor for prevention of postpartum hemorrhage.

Keywords: Oxytocin; Postpartum hemorrhage; Sublingual misoprostol.