Comparison of Oral Misoprostol with Intravenous Oxtocin in the In the Management of the Third Stage of Labour: A Randomized Controlled Trial

Abstract

Background: Postpartum haemorrhage (PPH) is defined as the loss of 500ml of blood or more from the vagina following vaginal birth or 1000ml following caesarean delivery. The third stage of labour is the period between the delivery of the baby and the delivery of the placenta and membranes and its management is central to the prevention of postpartum haemorrhage (PPH). There are basically two methods of managing the third stage of labour namely active and physiological/expectant. The active management includes the use of uterotonic drugs immediately following delivery of the fetus, early cord clamping and cutting, and controlled umbilical cord traction. The active management of the third stage of labour with oxytocin has been found to reduce the risk of primary PPH significantly; however, the problem of inadequate supply of electricity, high cost and paucity of skilled manpower to administer it has negatively affected its use in developing countries and has made the search for a more suitable alternative expedient. Misoprostol on the other hand has been found to have good uterotonic activities, affordable and stable at room temperature; making its use in the resource-poor countries a veritable alternative. Aims: To determine if there is any difference in the efficacy of intravenous oxytocin over oral misoprostol in the management of the third stage of labour Study Design: This was a prospective, double-blinded, randomized trial of uncomplicated pregnant women who had vaginal delivery in the labour ward of the ESUT Teaching Hospital, Enugu. Sample Size: Two hundred (200) pregnant women who satisfied the inclusion criteria were recruited into the study with each arm accommodating 100 participants. Methodology: The eligible women were recruited on presentation to the labour ward after giving their consent. They were randomly allocated into 2 groups: A and B. Group A received 2 tablets (400µg) of oral misoprostol and 1mililtre(ml) of sterile water intravenously while group B received 2 tablets of white vitamin c and 1ml (10iu) of intravenous oxytocin immediately after cord clamping and cutting following the delivery of the baby. The patient was observed for significant clinical vaginal bleeding or PPH. For the purposes of this study, any bleeding/PPH accompanied with a greater than 30% rise in baseline pulse rate qualified for transfusion. A proforma was used to record the necessary data Statistical Analysis: Data collected from the study was analyzed with the Statistical Package for Social Sciences (SPSS) computer software version 20.0 for Windows. Statistical analysis was both descriptive and inferential at 95% confidence level. The socio-demographic variables were used to categorize the data and this was subjected to comparative statistical evaluation to yield frequencies, means, and percentages. Test of significance between class differences was by Pearson’s Chi-square test for categorical variables and student’s t-test for continuous variables. All P<0.05 at one degree of freedom (df=1) was considered statistically significant. Results and Conclusion: There was no significant difference in the number of women that received blood transfusion, the amount of blood transfused and the need for additional oxytocics on both arms of the study. However, there was a significant difference in the occurrence of side-effects with shivering and vomiting being prominent in the misoprostol and oxytocin arms respectively. Conclusion: There was no difference in the efficacy of oxytocin over misoprostol in the management of the 3rd stage of labour. We therefore, recommend that misoprostol can be adopted as an alternative/substitute to oxytocin in the management of the third stage of labour especially in developing countries.