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

NCT04063904 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-07-23

No results posted yet for this study

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

Interventions

DRUG

Mifepristone

One 200 mg pill (oral)

DRUG

Misoprostol

Two 400 mcg pills (sublingual)

Sponsors & Collaborators

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Ilana G Dzuba, MHS · Gynuity Health Projects

  • Maria Mercedes Vivas, MD · Fundacion Orientame

  • Juliette Ortiz · Fundacion Orientame

  • Beverly Winikoff, MD, MPH · Gynuity Health Projects

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-16
Primary Completion
2020-04-03
Completion
2021-04-03

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04063904 on ClinicalTrials.gov