A randomized trial of sublingual misoprostol to augment routine third-stage management among women at risk of postpartum hemorrhage

Picklu Chaudhuri, Arindam Majumdar
International Journal of Gynaecology and Obstetrics 2016, 132 (2): 191-5

OBJECTIVE: To assess whether a combination of misoprostol and oxytocin is more beneficial than oxytocin alone in reducing blood loss after vaginal delivery among women with known risk factors for postpartum hemorrhage (PPH).

METHODS: A randomized, double-blind trial was conducted in a medical college in eastern India among women aged at least 18 years who had known high-risk factors for PPH. Using a computer-generated random number sequence (block size 6-8), participants were randomly assigned to receive 400 μg misoprostol or matched placebo tablets sublingually, in addition to 10 units of oxytocin, after vaginal delivery. The primary outcomes were postpartum blood loss at 1 hour and frequency of PPH. Analyses were by intention to treat.

RESULTS: Both groups contained 144 participants. Postpartum blood loss at 1 hour after delivery was significantly lower among women who received misoprostol than among those who received placebo (225.8±156.7 mL vs 302.4±230.3 mL; P<0.001). The frequency of moderate PPH (500-999 mL) was significantly lower in the group receiving misoprostol than in the placebo group (5 [3.5%] vs 15 [10.4%] participants; P=0.03).

CONCLUSION: As compared with oxytocin alone, misoprostol with oxytocin more effectively reduced blood loss after vaginal delivery among women at risk of PPH. Clinical Trial Registry India:CTRI/2014/03/004491.

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