Evaluating the Safety, Acceptability and Feasibility of an Outpatient "Day Procedure" Service Documenting the Roles of Health Workers in the Provision of Medical Abortion at 13-18 Weeks Gestation
Overview
- Phase
- Phase 4
- Intervention
- Mifepristone + Misoprostol
- Conditions
- Abortion in Second Trimester
- Sponsor
- Gynuity Health Projects
- Enrollment
- 230
- Locations
- 3
- Primary Endpoint
- Successful medical abortion
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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 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.
Investigators
Eligibility 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
Arms & Interventions
Mifepristone + Misoprostol
Intervention: 200mg mifepristone followed 24-48 h later with 400mcg misoprostol (repeat Q3)
Intervention: Mifepristone + Misoprostol
Outcomes
Primary Outcomes
Successful medical abortion
Time Frame: 0 - 48 hours after first dose of mifepristone
Proportion of women who have a successful medical abortion without recourse to surgical intervention and return home on the same day as misoprostol induction
Secondary Outcomes
- Total dose of misoprostol(0 - 48 hours after first misoprostol dose)
- Safety - Proportion of participants who experience at least one of the following: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications(2 weeks after initial visit)
- Hospital admission time(Within 0 - 48 hours after the second dose of misoprostol)
- Induction-to-abortion interval(0 - 48 hours after first misoprostol dose)
- Tasks performed by certified staff(0 - 72 hours after receipt of mifepristone)
- Side Effects(0 - 48 hours after first dose of misoprostol)
- Initiation-to-abortion interval(0 - 72 hours after receipt of mifepristone)