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CLINICAL TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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 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.
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.
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