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

Study Overview
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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 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.

Official Title
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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

Conditions
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Abortion in Second Trimester

Intervention / Treatment
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* Drug: Mifepristone + Misoprostol


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mifepristone + Misoprostol<br>200mg mifepristone followed 24-48 h later with 400mcg misoprostol (repeat Q3) | Drug: Mifepristone + Misoprostol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 0 - 48 hours after first dose of mifepristone | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average induction-to-abortion interval | Time interval from administration of the first misoprostol dose until expulsion of both fetus and placenta | 0 - 48 hours after first misoprostol dose | 
| Average number of total doses of misoprostol | Total misoprostol doses administered from induction to delivery of placenta. | 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) | 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 | 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 | Within 0 - 48 hours after the second dose of misoprostol | 
| Average pain scores | Severity incidence based on a 0-10 point pain scale | 0 - 48 hours after first dose of misoprostol | 
| Frequency of individual side effects experienced by participants | Side effects evaluated include diarrhea, nausea, vomiting, fever, chills | 0 - 48 hours after first dose of misoprostol | 
| Proportion of reported complications | Participants who returned to a health facility for evaluation and management of complications within 2 weeks of taking mifepristone | 0-2 weeks after initial visit | 
| Proportion of satisfied participants | Participants who report high satisfaction with service | 2 weeks after initial visit |