A double-blind placebo controlled randomised trial of misoprostol and oxytocin in the management of the third stage of labour

Abstract

Objective: To compare oral misoprostol 400 μg with intramuscular oxytocin 10 IU in the routine management of the third stage. Design: Double-blind placebo controlled trial. Setting: Main referral hospital and its associated polyclinics in Accra, Ghana. Population: Four hundred and one low risk women, in the second stage of labour with anticipated vaginal delivery, who entered labour spontaneously. Methods: After delivery of the anterior shoulder of the baby, the women were randomised to receive either: 1. misoprostol 400 μg powder in water orally and 1 mL normal saline intramuscular injection (placebo); or 2. powdered cellulose in water orally (placebo) and 1 mL oxytocin 10 IU intramuscular injection. Main outcome measures: Change in haemoglobin concentration from before delivery to 12 hours postpartum. Secondary outcomes included need for additional oxytocics, blood loss > 500 mL and > 1000 mL, operative intervention for postpartum haemorrhage, and side effects, including nausea, vomiting, diarrhoea, shivering and elevated temperature. Results: Demographic characteristics were similar. There was no significant difference in change in haemoglobin concentration between the two groups (0.60 g/dL for misoprostol and 0.55 g/dL for oxytocin; relative difference 9.6%; 95% CI 20.5-39.6%; P = 0.54). There were no significant differences in secondary outcomes with the exception of shivering, which occurred more frequently in the misoprostol group (22.2% vs 5.7%; relative risk 4.73; 95% CI 2.31-9.68; P < 0.0001). Conclusions: In low risk women oral misoprostol appears to be as effective in minimising blood loss in the third stage of labour as intramuscular oxytocin. Shivering was noted more frequently with misoprostol use, but no other side effects were noted. Misoprostol has great potential for use in the third stage of labour especially in developing countries.