Medical termination of pregnancy with mifepristone and misoprostol combined therapy: Evaluation of its safety and efficacy in clinical practice in India

Abstract

Background and Objective: Most current clinical protocols for medical termination of pregnancy require the use of prostaglandins in combination with an antiprogesterone. The present prospective observational study was undertaken to assess the safety and efficacy of mifepristone and misoprostol combined therapy in Indian women. Settings and Design: An observational study involving six doctors across the various states of India, who prescribed mifepristone and misoprostol combined therapy to adult women (≥ 18 years) requiring medical termination of intrauterine pregnancy (MTP) upto 63 days’ gestation. Methods and Material: Mifepristone was administered under the supervision of the qualified service providers as specified under MTP Act 2002 & MTP Rules 2003 in a total of 270 pregnant women who had opted for the medical termination of their pregnancy. Adverse events which were observed during the therapy were recorded. Efficacy rates were determined as complete abortion rate, incomplete abortion rate or no response rate observed at Day 14. Results: On clinical assessment, 96.3% cases aborted successfully. Ultrasonography assessment for confirmation of termination of pregnancy was carried out in 190 subjects (70.4% of 270) at the end of 14 days therapy with mifepristone and misoprostol combined therapy and 94.7% women amongst them had shown a complete termination of pregnancy. Side-effects were observed in 11.1% of the women – the commonest being nausea & vomiting (6.7%) and abdominal pain (3.7%). Conclusions: The present observational study demonstrates that mifepristone and misoprostol combined therapy is an effective and well tolerated medication in Indian adult women (≥ 18 years) requiring medical termination of intrauterine pregnancy (MTP) up to 63 days’ gestation.