Benefit of misoprostol for prevention of postpartum hemorrhage in cesarean section: A randomized controlled trial

Objectives.-To assess the benefit of sublingual misoprostol in addition to standard oxytocin in the prevention of post-partum hemorrhage at caesarean section. Patients and methods.-This was a prospective randomized controlled clinical trial conducted from March to June 2007 at our department of obstetrics-Sousse-Tunisia, including 250 single tow risk pregnant women undergoing caesarean section at gestational age > 32 weeks gestation. Patients were randomly assigned to receive at cord clamping either sublingual 200 mu g misoprostol (Cytotec (R)) with 20 UI intravenous oxytocin (Oxytocin (R): bolus 10 UI and infusion 10 UI in 500 ml Ringer Lactate): Group I, or only oxytocin at the same dose: Group II. The main outcome was total blood loss assessed by decrease in perioperative hematocrit. Secondary outcomes included measured collected blood toss, drop in hemoglobin level, additional oxytocin, side-effects and postoperative complications. Results.-The two groups were similar in demographic and obstetrical patient characteristics. Drop in hematocrit was more important in group II than in group 1: 4.30%+/- 3.14 versus. 1.10%+/- 3.25; P = 0.013. Drop in hemoglobin level was also more important in group II than in group 1: 1.03 g/dl +/- 1.19 versus 0.54 g/dl +/- 1.17; P < 0.01. Collected blood loss was less important in group I than in group II: 669.68 cc +/- 333.01 versus 852.52cc +/- 295.08; P < 0.01. Need for additional oxytocin and postoperative complications rate were more frequent in group II than in group I but the differences weren't significant. The rate of transient shivering, nausea and fever was significantly higher among women receiving misoprostol. Conclusions.-Subtinguat misoprostol (in addition to oxytocin) is effective in prevention of postpartum hemorrhage at caesarean sections when compared to oxytocin alone, without major side-effects. Larger studies are needed to confirm our results. (C) 2009 Elsevier Masson SAS. All rights reserved.