Misoprostol in the management of the third stage of labour in the home delivery setting in rural Gambia: a randomised controlled trial

Abstract

Objective: To assess the effectiveness of 600 microg oral misoprostol on postpartum haemorrhage (PPH) and postpartum anaemia in a low income country home birth situation.

Design: Double blind randomised controlled trial.

Setting: Twenty-six villages in rural Gambia with 52 traditional birth attendants (TBAs).

Sample: One thousand, two hundred and twenty-nine women delivering at home under the guidance of a trained TBA.

Methods: Active management of the third stage of labour using three 200-microg misoprostol tablets and placebo or four 0.5-mg ergometrine tablets (standard treatment) and placebo. Tablets were taken orally immediately after delivery.

Main outcome measures: Measured blood loss, postpartum haemoglobin (Hb), difference between Hb at the last antenatal care visit and three to five days postpartum.

Results: The misoprostol group experienced lower incidence of measured blood loss > or =500 mL and postpartum Hb <8 g/dL, but the differences were not statistically significant. The reduction in postpartum (compared with pre-delivery) Hb > or = 2 g/dL was 16.4% with misoprostol and 21.2% with ergometrine [relative risk 0.77; 95% confidence interval (CI) 0.60-0.98; P= 0.02]. Shivering was significantly more common with misoprostol, while vomiting was more common with ergometrine. Only transient side effects were observed.

Conclusions: Six hundred micrograms of oral misoprostol is a promising drug to prevent life-threatening PPH in this setting.