Status:
COMPLETED
Outpatient Service for Mid-trimester Termination of Pregnancy
Lead Sponsor:
Gynuity Health Projects
Collaborating Sponsors:
CREHPA
Kathmandu Medical College and Teaching Hospital
Conditions:
Abortion in Second Trimester
Eligibility:
FEMALE
Phase:
PHASE4
Brief Summary
This study seeks to evaluate the safety, acceptability and feasibility of an outpatient "day procedure" for medical abortion at 13-18 weeks gestation. The study regimen will consist of a single dose o...
Eligibility Criteria
Inclusion
- Have an ongoing pregnancy of 13-18 weeks gestation
- Meet legal criteria to obtain an abortion at 13-18 weeks gestation (legal criteria include pregnancy resulting from rape or incest, fetal malformation and/or if the pregnancy affects the physical or mental health of the woman)
- Has access to a phone where she can be reached at the 2-week follow-up
- Be willing to follow 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
- Living more than 2 hours away from the hospital
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT03346629
Start Date
December 1 2017
End Date
December 31 2018
Last Update
April 26 2019
Active Locations (3)
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1
KIST Medical College, Teaching Hospital
Imadol, Lalitpur, Nepal
2
Kathmandu Medical College
Kathmandu, Nepal
3
Kathmandu Model Hospital
Kathmandu, Nepal