Prophylactic Administration of Per Rectal Misoprostol vs Intramuscular Injection of Oxytocin in Third-stage of Labour for Prevention of Postpartum Haemorrhage: A Randomised Controlled Trial

Abstract

Introduction: In India, the routine Active Management of Third- Stage of Labour (AMTSL) with conventional intramuscular oxytocin, at the rural, resource-constrained areas, is often compromised due to lack of trained healthcare personnel and proper maintenance of cold chain system, causing maternal mortality and morbidity from Postpartum Haemorrhage (PPH). In these scenarios, tablet misoprostol, can be efficacious and convenient alternative. Aim: To evaluate efficacy and safety of misoprostol administered per rectum with respect to intramuscular oxytocin for effective control of PPH in a Randomised Controlled Trial (RCT). Materials and Methods: In this RCT, conducted in Sambhunath Pandit Hospital, kolkata, West Bengal, India from September 2015 to August 2016, total 80 eligible pregnant mothers in normal labour with prior consent and fulfilled criteria, were allocated to two separated groups (n=40) by computer generated randomisation table. Control group received 10 IU injection oxytocin and case group received 600 μg misoprostol tablet per rectally within one minute of cord clamping and cutting. The primary outcome measures were mean third- stage and mean postpartum blood loss up to eight hours after delivery. Secondary outcome variables were Mean Arterial Pressure (MAP) after eight hours postdelivery, haemoglobin and haematocrit after 24 hours of delivery and reported side effects. Data was entered into a Microsoft excel spreadsheet and statistical analysis was done by Statistical Package for the Social Sciences (SPSS) version 20.0.1 and Graph Pad Prism version 5.0. Results: Total sample size was 80 equally divided into two groups, with a mean age of 23.20±3.1558 years and 23.7750±3.8927 years in case and control group respectively. The mean third-stage blood loss (332.4105±72.6632 mL versus {vs} 329.0088±59.4503 mL, p=0.8193) and mean total blood loss (426.5575±80.0215 mL vs 424.8783±61.5808 mL, p=0.9165) were statistically indifferent between misoprostol and oxytocin groups by two-sample t-tests. The mean for eight hours postpartum MAP (p=0.0894), 24 hours postpartum haemoglobin (p=0.4534) and haematocrit (p=0.1325) were statistically insignificant between the two groups by two- sample t-tests. Incidence of adverse effects like shivering, diarrhoea, compared by Pearson’s Chi-square test, were found to be more but non significant in misoprostol group. Conclusion: This study concludes that per-rectal misoprostol is equally effective as intramuscular oxytocin to control PPH without significant adverse effects.