Outpatient Service for Mid-trimester Termination of Pregnancy

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. 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.

Official Title
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Evaluating the Safety, Acceptability and Feasibility of an Outpatient Day Procedure Service Documenting the Roles of Health Workers in the Provision of Medical Abortion at 13-18 Weeks Gestation

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction-to-abortion interval | Median time elapsed between administration of the first misoprostol dose until expulsion of both fetus and placenta | 0 - 48 hours after first misoprostol dose | 
| Total dose of misoprostol | Average number of doses of misoprostol | 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 | 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) | 0 - 72 hours after receipt of mifepristone | 
| Hospital admission time | Average total hospital admission time | Within 0 - 48 hours after the second dose of misoprostol | 
| Side Effects | Proportion of participants experiencing side effects (severity incidence, and severity of pain based on a 0-10 point scale) | 0 - 48 hours after first dose of misoprostol | 
| Initiation-to-abortion interval | Median time elapsed between administration of the mifepristone dose until expulsion of both fetus and placenta | 0 - 72 hours after receipt of mifepristone |