Outpatient Service for Mid-trimester Termination of Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Abortion in Second Trimester

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mifepristone + Misoprostol

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

Group Type EXPERIMENTAL

Mifepristone + Misoprostol

Intervention Type DRUG

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.

Interventions

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Mifepristone + Misoprostol

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.

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes