A randomized controlled trial of the safety and efficacy of preoperative rectal misoprostol for prevention of intraoperative and postoperative blood loss at elective cesarean delivery

Abstract

Objective: To assess the safety and efficacy of preoperative rectal misoprostol for the prevention of intraoperative and postoperative blood loss in women undergoing elective cesarean delivery.

Methods: A single-blind randomized controlled trial of 200 full-term pregnant women scheduled for elective cesarean delivery. Computer-generated randomization allocated women to receive 400 μg rectal misoprostol at urinary catheter insertion plus 400 μg rectally after abdominal closure (preoperative group, n=100) or 800 μg of rectal misoprostol after abdominal closure (postoperative group, n=100). Primary outcome was intraoperative blood loss.

Results: Intraoperative blood loss was significantly lower in the preoperative misoprostol group compared with the postoperative group (528.7 ± 114.8 mL vs 788.6 ± 165.8 mL; P<0.001). Blood loss during the first 24 hours after delivery was also lower in the preoperative group (199.3 ± 84.5 mL vs 302.9 ± 125.6 mL; P<0.001). Fewer women in the preoperative group needed additional uterotonics (7 vs 21; P<0.001). After delivery, the decrease in both hemoglobin and hematocrit levels was significantly less in the preoperative group (-6.8 vs -12.8% and -6.05 vs -17.8%, respectively; P<0.001).

Conclusion: Preoperative rectal administration of misoprostol significantly reduced intraoperative and postoperative blood loss during and after elective cesarean delivery. ClinicalTrial.gov ID: NCT03680339. Date of registration 9/2018.

Keywords: Egypt; Elective cesarean delivery; Intraoperative blood loss; Misoprostol; Postpartum hemorrhage; Randomized controlled trial; Rectal route.