Gj. Hofmeyr et al., A RANDOMIZED PLACEBO-CONTROLLED TRIAL OF ORAL MISOPROSTOL IN THE 3RD STAGE OF LABOR, British journal of obstetrics and gynaecology, 105(9), 1998, pp. 971-975
Objective To compare oral misoprostol 400 mu g with placebo in the rou
tine management of the third stage of labour. Design A double-blind pl
acebo controlled trial. Setting The labour ward of an academic hospita
l in Johannesburg, South Africa with 7000 deliveries per annum. Partic
ipants Low-risk women expected to deliver vaginally. Methods Women in
labour were randomly allocated to receive either misoprostol 400 mu g
orally or placebo after the birth. Conventional oxytocics were given i
mmediately 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 greater than or equal to 1000 mi within the first
hour after birth. Use of additional oxytocics. Results The groups wer
e well matched. Measured blood loss greater than or equal to 1000 mi o
ccurred in 15/250 (6%) after misoprostol and 23/250 (9%) after placebo
(relative risk 0.65; 95% confidence interval 0.35-1.22). The differen
ce may have been reduced by the greater use of conventional oxytocics
in the placebo group, which was statistically significant for intraven
ous oxytocin infusion(2.8% vs 8.4%, relative risk 0.33, 95% confidence
interval 0.14-0.77). Shivering was more common in the misoprostol gro
up (19% 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 s
ide effect of misoprostol administered orally in the puerperium. No se
rious side effects were noted. Misoprostol shows promise as a method o
f preventing postpartum haemorrhage. Because of the potential benefits
for childbearing women, particularly those in developing countries, f
urther research to determine its effects with greater certainty should
be expedited.