Publication:

Adjunctive sublingual misoprostol for secondary prevention of post-partum hemorrhage during cesarean delivery: double blind placebo randomized controlled trial

Background Cesarean delivery is the most frequently performed major operative procedure worldwide. Objective of present study was to evaluate randomized evidence regarding efficacy and safety of sublingual misoprostol for secondary prevention of post-partum hemorrhage during and after cesarean delivery in women receiving prophylactic oxytocin as primary preventive tools and bleed around 500ml by visual analogue estimation.

Methods A prospective, randomized, double-blind, placebo-controlled trial was performed at an obstetrics and gynecology department Aswan university hospital, Egypt, between October 2015 and September 2017. Women were eligible if they were undergoing elective cesarean under spinal anesthesia and were bleed around 500ml by visual analogue estimation. All participants received 10 IU oxytocin after delivery of the newborn. Participants were randomly assigned (1:1) to receive 400 μg misoprostol or matched placebo sublingually using a computer-generated random number sequence. Participants and providers were masked to assignment. The primary outcomes were intraoperative and postoperative blood loss.

Results There was high significant reduction in intraoperative blood loss in misoprostol group (711.0±188.41) compared with placebo group (915.33±293.72) (P=0.0001). The all estimated blood loss during CS and 24 hours postoperative was significant lower in misoprostol group (890.39±194.49) than that in placebo group (1096.9±300.05) (p=0.0001).

Conclusions Misoprostol as an adjunct to oxytocin as secondary prevention of pot partum hemorrhage seemed to be more effectively reduce blood loss than did placebo with oxytocin alone.