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

Phase 4

Terminated

• Conditions: Second Trimester Abortion
• Interventions: Drug: Mifepristone; Drug: Misoprostol

• Registration Number: NCT04063904
• Lead Sponsor: Gynuity Health Projects

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2019-08-20
• Study First Posted: 2019-08-21
• Study Start: 2019-10-16
• Primary Completion: 2020-04-03
• Study Completion: 2021-04-03
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mifepristone and misoprostol	Misoprostol	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.
Mifepristone and misoprostol	Mifepristone	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.

Primary Outcome Measures

Name	Time	Method
Successful medical abortion	0-60 hours after mifepristone	Proportion of women who have a successful abortion with medication only and are discharged from care on the same day as misoprostol induction.

Secondary Outcome Measures

Name	Time	Method
Pain with procedure	0-12 hours after first misoprostol dose	Mean pain score (scale 0-10)
Induction-to-abortion interval	0-12 hours after misoprostol	Time (median min/hrs) from first misoprostol dose until fetal and placental expulsion
Initiation-to-abortion interval	0-60 hours after mifepristone	Time (median min/hrs) from mifepristone administration until fetal and placental expulsion
Total clinic time	0-12 hours from arrival at clinic on day of induction with misoprostol	Time (median hrs) since arrival to clinic on day of misoprostol dosing to discharge from care that same day
Tasks performed by clinic staff	From enrollment through discharge from care (approx. 3 days)	Type of task performed (i.e. counseling, monitoring vital signs, administering drugs, monitoring woman's condition, post-abortion contraception, managing discharge) per cadre of provider
Total dose of misoprostol administered	0-12 hours after misoprostol	Mean number of misoprostol doses administered to achieve abortion
Satisfaction with procedure	Prior to discharge from care on day of abortion, up to 12 hours after first misoprostol dose	Proportion of participants who reported the procedure as satisfactory or very satisfactory
Side effects	0-12 hours after first misoprostol dose	Report of side effects and proportion of participants who experienced each one
Method safety	Two weeks after mifepristone	Proportion of participants who experience: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications

Trial Locations

Locations (1)

Fundacion Orientame; 🇨🇴 Bogotá, Colombia