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

Gynuity Health Projects

Status and phase: Terminated; Phase 4

Conditions: Second Trimester Abortion

Treatments: Drug: Mifepristone; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT04063904

1044

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

16 participants in 1 patient group

Mifepristone and misoprostol

Experimental group

Description:

Mifepristone 200 mg orally, followed 24-48 hours later by misoprostol 400mcg sublingually every three hours until the abortion occurs. The experimental part of the regimen is that the first dose of misoprostol will be taken 1-2 hours before arriving at the clinic for continued dosing, monitoring and abortion completion.

Treatment:

Drug: Mifepristone

Drug: Misoprostol