The Efficacy and Safety of Intrauterine Misoprostol During Cesarean Section in Prevention of Primary Post-Partum Hemorrhage - A Randomized Controlled Trial

Abstract

Postpartum hemorrhage remains the most common cause of maternal death globally [1]. and has persisted in low-income countries due to the prevalence of home deliveries and limited access to life-saving uterotonic drugs in these countries [2-5]. Many of the global gains in reducing maternal mortality can be attributed to developments in preventing and treating Postpartum Hemorrhage (PPH) [6,7]. PPH is often associated with the failure of the uterus to contract after delivery and is categorized as blood loss of 500 mL or more following a vaginal delivery or 1,000 mL after cesarean delivery [8,9]. PPH is categorized as primary if it occurs within 24 hours of delivery and secondary if excessive blood loss occurs at 24 hours or more after delivery. To compare the efficacy and safety of intrauterine misoprostol with intravenous oxytocin during Cesarean Section (CS) in prevention of primary post-partum hemorrhage. A total of 150 pregnant women at term (37-40 weeks) gestation who were scheduled for either elective or emergency caesarean delivery were enrolled. They were equally randomized into two groups: women who received 400mcg intrauterine misoprostol in addition to intravenous infusion of 10 IU oxytocin as Group I while women who received an intravenous infusion of 10 IU oxytocin after delivery of the neonate as Group II. The Primary outcome measures were Estimated Blood Loss (EBL) during caesarean section and need for additional uterotonic drugs intraoperatively. Secondary outcomes included the occurrence of excessive blood loss (>1000mL) within the first 6 hours postoperatively and the occurrence of any maternal or fetal side effects. The difference in the postoperative haemoglobin and postoperative hematocrit was found to be highly significant between the two groups (10.12 ± 1.55 vs 9.24 ± 1.52; p < 0.01) and (2.48 ± 1.38 vs 3.75 ± 1.77; p < 0.001) respectively. Estimated blood loss in two groups was found to be very highly significant (440.19 ± 257.75 vs 677.38 ± 343.04; p < 0.001). Intraoperative blood loss was significantly lower in the group I compared to group II (408.27 ± 123.34 vs 486.04 ± 135.84; p < 0.001). Blood loss during the first 6 hours after delivery was also lower in the group I (58.87 ± 9.86 mL vs 63.29 ± 12.39 mL; p < 0.05). Fewer women in the intrauterine misoprostol group needed additional uterotonics (7 vs 11; p > 0.05). The difference in the side effects of both the groups was found to be statistically non-significant. Apgar scores at 1 and 5 minutes were comparable in both the groups. The combined use of intrauterine misoprostol (400 mg), when added to oxytocin infusion during caesarean section is effective in decreasing the intraoperative blood loss, post-operative blood loss and prevent postpartum hemorrhage. keywords: Intrauterine misoprostol; Intraoperative estimated blood loss; Cesarean section; Postpartum hemorrhage