NCT02745093

Medical Abortion at Gestational Age of 8 to ≤9 Weeks Versus >9 to ≤12 Weeks

The Effectiveness, Safety, and Acceptability of Home-administered Medical Abortion at Gestational Age of 8 to ≤9 Weeks Versus >9 to ≤12 Weeks: A Prospective Cohort Study in Mexico City

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 648 (estimated)
• Sponsor: Ibis Reproductive Health · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effectiveness, safety, and acceptability of home-administered medical abortion at gestational age of 8 to ≤9 weeks versus \>9 to ≤12 weeks among a cohort of women in Mexico City.

Detailed description

Medical abortion represents an important alternative to surgical methods for termination of early pregnancy. In Mexico City, abortion is legal on request up to 12 weeks of gestation; however, medical abortion is currently only offered up to 10 weeks at Marie Stopes Mexico clinics. The World Health Organization guidelines state that medical abortion drugs may be used to terminate pregnancy up to a gestational age of 24 weeks in clinical settings, with recommended regimens differing by gestational age. However, data are lacking on the safety and effectiveness of home-based medical abortion regimens for pregnancy terminations between \>9 and ≤12 weeks' gestation. Investigators propose a prospective cohort study with women between 8 and ≤9 weeks and \>9 and ≤12 weeks of pregnancy at Marie Stopes Mexico clinics to compare the effectiveness, safety, and acceptability of mifepristone followed by home-based misoprostol use in these two gestational age groups. The information from this study will inform policy and practice guidelines in Mexico City and potentially other locations by providing evidence on the safety, effectiveness, and acceptability of home-use of medical abortion between \>9 and ≤12 weeks of gestation.

Conditions

• Medical Abortion

Interventions

Type	Name	Description
DRUG	Mifepristone	Women at 64-84 days' gestation will use the following dosing regimen: 200 µg mifepristone administered orally in the clinic on Day 1.
DRUG	Misoprostol	The client will then be given a total of 2400 µg misoprostol tablets to take home, and will be instructed to take 800 μg misoprostol administered sublingually 24-48 hours later at home and to administer a subsequent dose of 400 μg misoprostol sublingually every 3 hours up to a total of four further doses or until expulsion of the products of conception, whichever comes first.

Timeline

• Start date: 2016-09-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-04-20
• Last updated: 2016-06-20

Locations

3 sites across 1 country: Mexico