[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 low risk pregnant women undergoing caesarean section at gestational age>32 weeks gestation. Patients were randomly assigned to receive at cord clamping either sublingual 200microg misoprostol (Cytotec) with 20UI intravenous oxytocin (Oxytocin): bolus 10UI and infusion 10UI in 500ml 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 loss, 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 I: 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 I: 1.03g/dl+/-1.19 versus 0.54g/dl+/-1.17; P<0.01. Collected blood loss was less important in group I than in group II: 669.68cc+/-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: Sublingual misoprostol (in addition to oxytocin) is effective in prevention of post-partum hemorrhage at caesarean sections when compared to oxytocin alone, without major side-effects. Larger studies are needed to confirm our results.

RCT Entities:   Population Interventions Outcomes