NCT04063904

Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This pilot study seeks to evaluate the safety, acceptability and feasibility of a shortened outpatient procedure for medical abortion at 13-18 weeks gestation. It also seeks to document the roles of health workers in providing services related to later abortion care. Participants will take a single dose of 200 mg mifepristone orally, followed 24-48 hours later with 400 mcg misoprostol sublingually prior to arriving at the study clinic. Repeat doses of 400 mcg misoprostol will be administered sublingually every three hours at the clinic until the abortion is achieved. If expulsion does not occur by a certain time prior to the clinic closing that day, D\&E will be performed to complete the abortion.

Conditions

• Second Trimester Abortion

Interventions

Type	Name	Description
DRUG	Mifepristone	One 200 mg pill (oral)
DRUG	Misoprostol	Two 400 mcg pills (sublingual)

Timeline

• Start date: 2019-10-16
• Primary completion: 2020-04-03
• Completion: 2021-04-03
• First posted: 2019-08-21
• Last updated: 2021-07-23

Locations

1 site across 1 country: Colombia