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

• Status: Terminated
• Trial end date: 2021-04-03
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gynuity Health Projects
• Treatments: Mifepristone; Misoprostol

Criteria

Inclusion Criteria:

1. Have an intrauterine pregnancy of 13-18 weeks gestation according to ultrasound

2. Meet legal criteria to obtain abortion

3. Be at least 18 years old

4. Have access to a phone where she can be reached for the 2-week follow up

5. Be willing to follow pilot study procedures

Exclusion Criteria:

1. Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol

2. Any contraindications to vaginal delivery

3. More than one prior cesarean delivery

4. Staying more than 2 hours away from the clinic