[Benefit of misoprostol for prevention of postpartum hemorrhage in cesarean section: a randomized controlled trial].

OBJECTIVE

To assess the benefit of sublingual misoprostol in addition to standard oxytocin in the prevention of post-partum hemorrhage at caesarean section.

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.