Side effects of oral misoprostol during the first 24 hours after administration in the third stage of labour

Abstract Objective To evaluate the side effects of 600 μg misoprostol orally during the first 24 hours after administration in the third stage of labour. Design Double blind randomised controlled trial. Setting Tertiary care hospitals in Nigeria and Thailand. Sample All women participating in the WHO Misoprostol trial in these two hospitals between January 1, 1999 and June 17, 1999. Methods All women were followed up during the first 24 hours postpartum to evaluate the occurrence of shivering, nausea, vomiting, diarrhoea and other misoprostol-related side effects. Main outcome measures Rates of shivering, nausea, vomiting, diarrhoea and pyrexia within 1 hour and in the intervals 2–6, 7–12, 13–18 and 19–24 hours after delivery. Results A total of 1686 women were enrolled. Women who received misoprostol had higher incidence than the oxytocin group of ‘any’ shivering in the first hour (RR 6.4, 95% CI 3.9 to 10.4) and the period covering 2–6 hours following delivery (RR 4.7, 95% CI 1.9 to 11.2). Pyrexia was also more common in the misoprostol group in both the same time intervals (RR 2.8, 95% CI 1.4 to 5.3 and RR 6.3, 95% CI 3.7 to 10.8, respectively). Diarrhoea was not present in the first hour in either group but appeared in the second time period (2–6 hours) and third time period (7–12 hours) more frequently in the misoprostol group than with oxytocin. Conclusion The increased incidence of shivering and pyrexia that occurs with postpartum use of misoprostol persists up to 6 hours following delivery. Approximately 5% of women experience diarrhoea that starts after 1 hour and subsides within 12 hours.