randomised controlled trial of orally and rectally administered prostaglandin E1 analogue misoprostol and standard management of the third stage of labour in the prevention of postpartum haemorrhage

ABSTRACT

Misoprostol may have the potential to prevent atonic postpartum haemorrhage, when administered orally or rectally, and may be an alternative to conventional standard oxytocic regimens for the active management of third stage of labour. To examine the efficacy and side effects of oral versus rectal misoprostol compared to standard oxytocics for the prevention of postpartum haemorrhage. A prospective randomised controlled trial. Obstetric Unit of Cairo University Hospital [Kasr El-Aini]. Five hundred low risk women with anticipated vaginal delivery. In the third stage of labour, the women were randomised to 600 micro g misoprostol given orally [Group I; n=150] rectally [Group II; n= 150] after clamping and division of the cord, or to standard oxytocic regimens of syntometrine or syntocinon [Group III; n=200] after the delivery of the anterior shoulder. The main primary outcomes were changes in haemoglobin concentration and haematocrit from before delivery to 12 hours postpartum. Secondary outcomes were the side effects of drug regimens, including, nausea, vomiting, diarrhoea, shivering and elevated temperature. The baseline demographic characteristics and labour variables were similar. There were no statistically significant differences [P>0.05] between the groups in the changes of haemoglobin concentrations and haematocrit [the main primary outcomes], the estimated blood loss, the incidence of postpartum haemorrhage, the incidence of severe postpartum haemorrhage, the proportions of women requiring blood transfusion, the length of the third stage, the incidence of prolonged third stage, the need for manual removal of the placenta, the percentage of women requiring additional oxytocic administration and the incidence of delayed haemorrhage in post natal ward. The main side effects were shivering and a rise in temperature, which occurred more frequently in the oral misoprostol group [P-overall <0.001 and 0.012 respectively]. Other side effects were mild with no differences between the groups. Oral and rectal misoprostol were comparable to standard oxytocics for the prevention of postpartum haemorrhage. Shivering and pyrexia were the main side effects of oral misoprostol. Of importance is the apparent lack of these side effects with the rectal route. Further randomised controlled trials are required to identify the best drug combinations, route, and dose for the prevention of postpartum hemorrhage