A Study of Acceptability and Feasibility of an Outpatient "Day Procedure" for Medical Abortion at 13-18 Weeks Gestation in Two Public Sector Hospitals in Nepal

Gynuity Health Projects2 sites in 1 country120 target enrollmentNovember 25, 2020

ConditionsAbortion in Second Trimester

InterventionsMifepristone + Misoprostol

DrugsMifepristone + Misoprostol

Overview

Phase: Phase 4
Intervention: Mifepristone + Misoprostol
Conditions: Abortion in Second Trimester
Sponsor: Gynuity Health Projects
Enrollment: 120
Locations: 2
Primary Endpoint: Proportion of participants with method success on the same day as misoprostol initiation.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 25, 2020

End Date

August 31, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Gynuity Health Projects

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have an ongoing pregnancy of 13-18 weeks gestation
•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)
•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
•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

Arms & Interventions

Mifepristone + Misoprostol

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

Intervention: Mifepristone + Misoprostol

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

Average pain scores(0 - 48 hours after first dose of misoprostol)
Frequency of individual side effects experienced by participants(0 - 48 hours after first dose of misoprostol)
Proportion of reported complications(0-2 weeks after initial visit)
Average number of total doses of misoprostol(0 - 48 hours after first misoprostol dose)
Average total hospital admission time(Within 0 - 48 hours after the second dose of misoprostol)
Average induction-to-abortion interval(0 - 48 hours after first misoprostol dose)
Description of tasks performed by different cadres of study staff(0 - 72 hours after receipt of mifepristone)
Frequency of adverse events(0-2 weeks after initial visit)
Proportion of satisfied participants(2 weeks after initial visit)