Misoprostol in the management of the third stage of labour in the home delivery setting in rural Gambia: a randomised controlled trial Gijs Walraven, a Jennifer Blum, b Yusupha Dampha, a Maimuna Sowe, a Linda Morison, c Beverly Winikoff, d Nancy Sloan b Objective To assess the effectiveness of 600 Ag 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-Ag 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 ¼ 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. INTRODUCTION Approximately 529,000 women die each year from the complications of pregnancy and childbirth, and an estimated 95% of these deaths occur in sub-Saharan Africa and Asia. 1 Haemorrhage is thought to be the largest single medical cause of maternal death, accounting for about 25% of the total and claiming an estimated 150,000 lives annually. 2 Most of these deaths are due to postpartum haemorrhage (PPH), resulting from atonic uterus. The rapidity with which women die once massive haemorrhage starts presents a major problem in settings where delays in reaching and re- ceiving effective intervention are common. Home birth remains a strong preference, and often the only option, for many women in low income countries. The World Health Organization estimates that 60% of births in the group of low income countries occur outside a health facility. 3 The International Confederation of Midwives and the International Federation of Gynaecologists and Obste- tricians recommend that all women receive active manage- ment of the third stage of labour. 4 A large multicentre hospital study showed that injected oxytocin was statisti- cally significantly better than oral misoprostol in the pre- vention of PPH, reducing measured blood loss of 1000 mL or more from 4% to 3%. 5 Although these results are im- portant for hospital and health centre deliveries, they are not necessarily applicable to the home delivery setting in low income countries where the effective use of injectible oxytocin is more difficult, requiring safe administration and special storage to maintain stability (especially in tropical climates). It is in these rural settings where emergency health care is virtually inaccessible that the life-saving po- tential of misoprostol with its ease of administration, sta- bility and low cost could have major implications for women’s health. This randomised controlled trial sought to evaluate the impact of oral misoprostol on PPH compared with standard treatment in the home birth situation in rural BJOG: an International Journal of Obstetrics and Gynaecology September 2005, Vol. 112, pp. 1277–1283 D RCOG 2005 BJOG: an International Journal of Obstetrics and Gynaecology www.blackwellpublishing.com/bjog a Farafenni Field Station, Medical Research Council Laboratories, Farafenni, Gambia b Population Council, New York, USA c London School of Hygiene and Tropical Medicine, London, UK d Gynuity Health Projects, New York, USA Correspondence: Professor G. Walraven, Secre ´tariat de Son Altesse l’Aga Khan, Aiglemont, Gouvieux 60270, France. DOI:10.1111/j.1471-0528.2005.00711.x