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

NCT04063904 | Terminated Phase 4 DMC

• 1 other identifier: 1044
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Second Trimester Abortion

Keywords

medical abortion; mifepristone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Induction-to-abortion interval

  0-12 hours after misoprostol

• Initiation-to-abortion interval

  0-60 hours after mifepristone

• Total dose of misoprostol administered

  0-12 hours after misoprostol

• Method safety

  Two weeks after mifepristone

• Tasks performed by clinic staff

  From enrollment through discharge from care (approx. 3 days)

Study Arms (1)

Mifepristone and misoprostol

EXPERIMENTAL

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; Drug: Misoprostol

Interventions

Mifepristone DRUG

One 200 mg pill (oral)

Mifepristone and misoprostol

Misoprostol DRUG

Two 400 mcg pills (sublingual)

Mifepristone and misoprostol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have an intrauterine pregnancy of 13-18 weeks gestation according to ultrasound
• Meet legal criteria to obtain abortion
• Be at least 18 years old
• Have access to a phone where she can be reached for the 2-week follow up
• Be willing to follow pilot study procedures

You may not qualify if:

• Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
• Any contraindications to vaginal delivery
• More than one prior cesarean delivery
• Staying more than 2 hours away from the clinic

Sponsors & Collaborators

• Gynuity Health Projects: lead

Study Sites (1)

Fundacion Orientame

Bogotá, Colombia

Location

MeSH Terms

Interventions

Mifepristone; Misoprostol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Ilana G Dzuba, MHS

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Maria Mercedes Vivas, MD

  Fundacion Orientame

  PRINCIPAL INVESTIGATOR

• Juliette Ortiz

  Fundacion Orientame

  STUDY DIRECTOR

• Beverly Winikoff, MD, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 21, 2019
• Study Start: October 16, 2019
• Primary Completion: April 3, 2020
• Study Completion: April 3, 2021
• Last Updated: July 23, 2021

Record last verified: 2021-07

Locations

CO (1)