A randomised placebo controlled trial of oral misoprostol in the third stage of labour

Abstract

Objective To compare oral misoprostol 400 pg with placebo in the routine management of the Design A double-blind placebo controlled trial. Setting The labour ward of an academic hospital in Johannesburg, South Africa with 7000Participants Low-risk women expected to deliver vaginally. Methods Women in labour were randomly allocated to receive either misoprosto1400 pg orally or placebo after the birth. Conventional oxytocics were given immediately if blood loss was thought to be more than usual. Postpartum blood loss in the first hour was measured by collection in a special flat plastic bedpan. Side effects were recorded.Main outcome measures Measured blood loss 2 1000 ml within the first hour after birth. Use of additional oxytocics.Results The groups were well matched. Measured blood loss 2 1000 ml occurred in 15/250 (6%) after misoprostol and 23/250 (9%) after placebo (relative risk 0.65; 95% confidence interval 0.35-1.22). The difference may have been reduced by the greater use of conventional oxytocics in the placebo group, which was statistically significant for intravenous oxytocin infusion (2.8% vs 8.4%, relative risk 0-33, 95% confidence interval 0.140.77). Shivering was more common in the misoprostol group (190/, vs 5%, relative risk 3.69; 95% confidence interval 2.05-6-64).Conclusions Shivering has been shown in this study to be a specific side effect of misoprostol administered orally in the puerperium. No serious side effects were noted. Misoprostol shows promise as a method of preventing postpartum haemorrhage. Because of the potential benefits for childbearing women, particularly those in developing countries, further research to determine its effects with greater certainty should be expedited.third stage of labour.deliveries per annum.

Misoprostol as a Drug in Prophylaxis And Management of Postpartum Haemorrhage

“…Mean rise of temperature was more than 0.10 F and statistically significant. Earlier investigations have also reported pyrexia with Misoprostol for first trimester abortion and in the third stage management 16 . Shivering was not known to be a side effect of Misoprostol prior to its use it for the 3 rd stage of labour.…”

Comparative study of the side effect profiles of oral misoprostol and parenteral oxytocin used in prevention of postpartum haemorrhage in Maiduguri Nigeria

“…The frequency of some adverse effects in the two medication groups of intravenous oxytocin (900 subjects) and oral misoprostol tablet (900 subjects). [11,12]. In a randomised controlled comparison between orally administered misoprostol and standard management in Universitty College Hospital, London, El-Refaey et al, (2000) concluded that many side effects were less common with misoprostol but shivering and pyrexia were more common.…”

Comparing and combining evidence of treatment effects in randomized and nonrandomized studies on the use of misoprostol to prevent postpartum hemorrhage

“…Twenty of the included studies were RCTs, [37][38][39][40][41][42][43][44][45][46][47][48][49][50][51][52][53][54][55][56] while the remaining 14 were NRS, 9,10,57-67 and together involved a total of 74 204 participants. Most of the NRS were prospective cohort studies, with sample sizes ranging from 400 to 34 631 participants.…”