Assessing Outpatient 'Day Procedure' for Second-trimester Medical Abortion at Two Public Sector Hospitals in Nepal

Gynuity Health Projects120 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 in two public sector facilities. It also seeks to document the roles of health workers in providing services related to later abortion care and to document the costs of this day procedure to the health system.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Abortion in Second Trimester

Interventions

Mifepristone + MisoprostolDRUG

A single 200 mg mifepristone (one tablet) 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 (buccal) every three hours until the abortion is achieved.

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Have an ongoing pregnancy of 13-18 weeks gestation 2. Meet legal criteria to obtain 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) 3. Have access to a phone where she can be reached at the 2-week follow up or willing to return to the clinic for an in-person interview with the research assistant 4. Be willing to follow study procedures Exclusion Criteria: 1. Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol 2. Any contraindications to vaginal delivery 3. More than one prior cesarean delivery 4. Living more than 2 hours away from the hospital

Locations (2)

Bharatpur Hospital

Bharatpur, Nepal

Lumbini Provincial Hospital

Butwāl, Nepal

Outcomes

Primary Outcomes

Proportion of participants with method success on the same day as misoprostol initiation.

Success is defined as expelling fetus and placenta without surgical intervention and return home on the same day

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

Secondary Outcomes

Average induction-to-abortion interval

Time interval from administration of the first misoprostol dose until expulsion of both fetus and placenta

Time frame: 0 - 48 hours after first misoprostol dose

Average number of total doses of misoprostol

Total misoprostol doses administered from induction to delivery of placenta.

Time frame: 0 - 48 hours after first misoprostol dose

Frequency of adverse events

Adverse events include extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, or prolonged hospitalization, any complications (immediate and delayed)

Time frame: 0-2 weeks after initial visit

Description of tasks performed by different cadres of study staff

Tasks evaluated include counseling, monitoring vital signs, administering drugs, monitoring woman's condition, post-abortion contraception, managing discharge

Time frame: 0 - 72 hours after receipt of mifepristone

Average total hospital admission time

Total hospital admission time, including: 1) total admission time during treatment with misoprostol and abortion recovery 2) Additional hospital time required for the evaluation and management of complications

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.