Status:
TERMINATED
Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia
Lead Sponsor:
Gynuity Health Projects
Conditions:
Second Trimester Abortion
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 h...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04063904
Start Date
October 16 2019
End Date
April 3 2021
Last Update
July 23 2021
Active Locations (1)
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1
Fundacion Orientame
Bogotá, Colombia