Efficacy of Vaginal Misoprostol Administered for Rapid Management of First Trimester Spontaneous Onset Incomplete Abortion in Comparison to Manual Vacuum Aspiration: A Randomised Clinical Trial

Abstract

Introduction: Both, surgical and medicinal techniques can be used vaginally to treat incomplete abortions. Although, Manual Vacuum Aspiration (MVA) is a safe and efficient surgical treatment for the management of incomplete abortion, it is not frequently offered and is not very cost effective in rural areas, especially in low resource settings. Misoprostol is an alternative to MVA for the treatment of incomplete abortion. Aim: To assess the effectiveness and acceptability of using vaginal misoprostol for the management of first trimester spontaneous incomplete abortion as an alternative to MVA. Materials and Methods: A randomised clinical trial was conducted between February 2020 to July 2021 in the Department of Obstetrics and Gynaecology, at RG Kar Medical College and Hospital, Kolkata, West Bengal, India. A total of 144 participants were randomised into two groups with 72 women in each group, to treatment with either MVA or 400 mcg vaginal at 3 hour intervals. The main outcome measures assessed at 24 hour follow-up were complete uterine evacuation confirmed by transvaginal sonography, and client acceptability and satisfaction were assessed from entry in data form by participants. Chi-square (χ2 ) tests were used for categorical data, and the Student’s paired t-test was used for continuous data. Statistical significance in all calculations was defined as p<0.05 and the study would follow the Intention To Treat (ITT) analysis while computing the results. Results: The mean ages were 27.44 years (6.8) and 28.47 years (6.6) for the misoprostol and MVA groups respectively. For the gestational age, the mean gestational ages were 8.88 (2.01) and 8.90 (2.17) weeks for the misoprostol and MVA groups, respectively. A higher failure rate in terms of incomplete abortion was encountered in the misoprostol arm compared to the MVA arm. Although this difference in complete uterine evacuation rate did not reach statistical significance (RR=4, 95% Confidence Interval (CI) 0.879-18.192, p=0.0728). Pyrexia appeared to be a significant complication in the misoprostol group compared to MVA group (p=0.038). There was no significant difference in satisfaction in both groups (p=0.659) and no significant difference in acceptability. Conclusion: As an alternative to surgical intervention, three 400 mcg misoprostol pills could be administered vaginally over the course of three hours to treat spontaneous first trimester uncomplicated incomplete abortion.