Outpatient Service for Mid-trimester Termination of Pregnancy

• Status: Completed
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: Female

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 of 200 mg mifepristone to be taken orally either at home or at the hospital, followed approximately 24 - 48 hours later with administration of 400 mcg misoprostol. Repeat doses of 400 mcg (two tablets) of misoprostol will be administered buccally every three hours until the abortion is achieved.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gynuity Health Projects
• Collaborators: Center for Research on Environment, Health and Population Activities; CREHPA; Kathmandu Medical College; Kathmandu Medical College and Teaching Hospital; Kathmandu Model Hospital; KIST Medical College; KIST Medical College, Teaching Hospital
• Treatments: Mifepristone; Misoprostol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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