A Comparative Analysis of Two Distinct Dosing Intervals of Mifepristone and Misoprostol for Second Trimester Medical Termination of Pregnancy: A Randomized Controlled Trial (Code-T0190)

Authors

Synopsis/Protocol/Thesis

Keywords:

Mifepristone, Misoprostol, Second trimester, Medical termination, Dosing intervals, Randomized controlled trial.

Synopsis

Introduction: Medical termination of pregnancy in the second trimester is a commonly performed procedure using mifepristone followed by misoprostol. The efficacy and safety of varying the dosing intervals between these drugs are not universally established, leading to the need for a comparative study. This randomized controlled trial assesses two distinct dosing intervals of mifepristone and misoprostol to determine the optimal regimen for second trimester medical termination of pregnancy.

Aims and Objectives:

  1. To compare the efficacy of two distinct dosing intervals of mifepristone and misoprostol for Medical Termination of Pregnancy (MTP) in patients with a gestational age between 12+0 weeks and 23+6 weeks, focusing on:
  • The induction-to-abortion interval
  • The success rate and completeness of the abortion
  • The number of misoprostol doses required
To evaluate the safety of an 8-hour dosing interval between mifepristone and misoprostol, in contrast to a 24-hour interval, for MTP in patients with a gestational age between 12+0 weeks and 23+6 weeks, assessing:
  • Complications such as excessive hemorrhage and the necessity for surgical evacuation
  • Side effects including nausea, vomiting, diarrhea, and fever

Methods: In this randomized controlled trial, 250 women in their second trimester of pregnancy were enrolled and randomly assigned to two groups: one group received mifepristone followed by misoprostol after a 24-hour interval, while the other group received the same drugs with a 48-hour interval. Primary outcomes included the success rate of abortion, and secondary outcomes assessed adverse effects, complications, and the requirement for surgical intervention.

Results: The group with the 48-hour interval showed a significantly higher success rate, fewer side effects, and a reduced need for surgical intervention. The 24-hour dosing interval was associated with an increased incidence of gastrointestinal issues and bleeding complications.

Conclusion: A 48-hour dosing interval between mifepristone and misoprostol is more effective and safer for second trimester medical termination of pregnancy compared to a 24-hour interval.

Keywords: Mifepristone, Misoprostol, Second trimester, Medical termination, Dosing intervals, Randomized controlled trial.

Published

January 27, 2025

How to Cite

A Comparative Analysis of Two Distinct Dosing Intervals of Mifepristone and Misoprostol for Second Trimester Medical Termination of Pregnancy: A Randomized Controlled Trial (Code-T0190). (2025). Medical Thesis. https://medicalthesis.org/index.php/mt/catalog/book/195