Trial | NCT03346629  Report issue

Title

Outpatient Service for Mid-trimester Termination of Pregnancy
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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    230
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.
Study Started
Dec 01
2017
Primary Completion
Dec 31
2018
Study Completion
Dec 31
2018
Last Update
Apr 26
2019

Drug Mifepristone + Misoprostol [mifepristone (mifeprex), misoprostol (cytotec)]

A single dose of 200 mg mifepristone (one tablet) to be taken orally either at home or at the hospital, followed 24-48 hours later with 400mcg misoprostol (buccal) at home. The participant will return to the hospital one to two hours after taking the initial dose of misoprostol to receive repeated doses of 400 mcg misoprostol until the abortion occurs.

Mifepristone + Misoprostol Experimental

Intervention: 200mg mifepristone followed 24-48 h later with 400mcg misoprostol (repeat Q3)

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
No Results Posted