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

Objective: To assess the effectiveness of 600 μg 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-μg 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 ≥500 mL and postpartum Hb <8 g/dL, but the differences were not statistically significant. The reduction in postpartum (compared with pre-delivery) Hb ≥ 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. © RCOG 2005.