Outpatient Service for Mid-trimester Termination of Pregnancy

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.

Conditions

• Abortion in Second Trimester

Interventions

DRUG

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.

Sponsors & Collaborators

• CREHPA

  collaborator UNKNOWN

• Kathmandu Medical College and Teaching Hospital

  collaborator OTHER

• Kathmandu Model Hospital

  collaborator UNKNOWN

• KIST Medical College

  collaborator UNKNOWN

• Gynuity Health Projects

  lead OTHER

Principal Investigators

• Jennifer Blum, MPH · Gynuity Health Projects

• Monica Dragoman, MD, MPH · Gynuity Health Projects

• Chanda Karki, MD · Kathmandu Medical College

• Dina Abbas, MPH · Gynuity Health Projects

• Beverly Winikoff, MD, MPH · Gynuity Health Projects

• Anand Tamang, MPhil · CREHPA

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-12-01

Primary Completion

2018-12-31

Completion

2018-12-31

Countries

• Nepal

Study Locations