Outpatient Service for Mid-trimester Termination of Pregnancy

Gynuity Health Projects230 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

230

Conditions

Abortion in Second Trimester

Interventions

Mifepristone + MisoprostolDRUG

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.

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

KIST Medical College, Teaching Hospital

Imadol, Lalitpur, Nepal

Kathmandu Medical College

Kathmandu, Nepal

Kathmandu Model Hospital

Kathmandu, Nepal

Outcomes

Primary Outcomes

Successful medical abortion

Proportion of women who have a successful medical abortion without recourse to surgical intervention and return home on the same day as misoprostol induction

Time frame: 0 - 48 hours after first dose of mifepristone

Secondary Outcomes

Induction-to-abortion interval

Median time elapsed between administration of the first misoprostol dose until expulsion of both fetus and placenta

Time frame: 0 - 48 hours after first misoprostol dose

Total dose of misoprostol

Average number of doses of misoprostol

Time frame: 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

Proportion of participants who experience at least one of the following: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications

Time frame: 2 weeks after initial visit

Tasks performed by certified staff

Type of task performed (i.e. counseling, monitoring vital signs, administering drugs, monitoring woman's condition, post-abortion contraception, managing discharge)

Time frame: 0 - 72 hours after receipt of mifepristone

Hospital admission time

Average total hospital admission time

Time frame: Within 0 - 48 hours after the second dose of misoprostol

Side Effects

Data from ClinicalTrials.gov

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