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

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.

Study Overview

• Status: Terminated
• Conditions: Second Trimester Abortion
• Intervention / Treatment: Drug: Mifepristone; Drug: Misoprostol

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 4

Contacts and Locations

Study Locations

• Colombia
  • Bogotá, Colombia
    • Fundacion Orientame

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mifepristone and 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.	Drug: Mifepristone; One 200 mg pill (oral); Drug: Misoprostol; Two 400 mcg pills (sublingual)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Investigators: Principal Investigator: Ilana G Dzuba, MHS, Gynuity Health Projects; Principal Investigator: Maria Mercedes Vivas, MD, Fundacion Orientame; Study Director: Juliette Ortiz, Fundacion Orientame

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2019
• Primary Completion (Actual): April 3, 2020
• Study Completion (Actual): April 3, 2021

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (Actual): August 21, 2019

Study Record Updates

• Last Update Posted (Actual): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: medical abortion; mifepristone
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Anti-Ulcer Agents; Contraceptives, Oral, Synthetic; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Misoprostol; Mifepristone
• Other Study ID Numbers: 1044

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No