Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia

Study Overview
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Brief Summary
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This pilot study seeks to evaluate the safety, acceptability and feasibility of a shortened outpatient procedure for medical abortion at 13-18 weeks gestation. It also seeks to document the roles of health workers in providing services related to later abortion care. Participants will take a single dose of 200 mg mifepristone orally, followed 24-48 hours later with 400 mcg misoprostol sublingually prior to arriving at the study clinic. Repeat doses of 400 mcg misoprostol will be administered sublingually every three hours at the clinic until the abortion is achieved. If expulsion does not occur by a certain time prior to the clinic closing that day, D&E will be performed to complete the abortion.

Official Title
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Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia

Conditions
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Second Trimester Abortion

Intervention / Treatment
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* Drug: Mifepristone
* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have an intrauterine pregnancy of 13-18 weeks gestation according to ultrasound Meet legal criteria to obtain abortion Be at least 18 years old Have access to a phone where she can be reached for the 2-week follow up Be willing to follow pilot 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 Staying more than 2 hours away from the clinic

Ages Eligible for Study
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Minimum Age: 18 Years

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 and misoprostol<br>Mifepristone 200 mg orally, followed 24-48 hours later by misoprostol 400mcg sublingually every three hours until the abortion occurs. The experimental part of the regimen is that the first dose of misoprostol will be taken 1-2 hours before arriving at the clinic for continued dosing, monitoring and abortion completion. | Drug: Mifepristone<br>* One 200 mg pill (oral)<br>Drug: Misoprostol<br>* Two 400 mcg pills (sublingual)<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 abortion with medication only and are discharged from care on the same day as misoprostol induction. | 0-60 hours after mifepristone | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction-to-abortion interval | Time (median min/hrs) from first misoprostol dose until fetal and placental expulsion | 0-12 hours after misoprostol | 
| Initiation-to-abortion interval | Time (median min/hrs) from mifepristone administration until fetal and placental expulsion | 0-60 hours after mifepristone | 
| Total dose of misoprostol administered | Mean number of misoprostol doses administered to achieve abortion | 0-12 hours after misoprostol | 
| Method safety | Proportion of participants who experience: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications | Two weeks after mifepristone | 
| Tasks performed by clinic staff | Type of task performed (i.e. counseling, monitoring vital signs, administering drugs, monitoring woman's condition, post-abortion contraception, managing discharge) per cadre of provider | From enrollment through discharge from care (approx. 3 days) | 
| Total clinic time | Time (median hrs) since arrival to clinic on day of misoprostol dosing to discharge from care that same day | 0-12 hours from arrival at clinic on day of induction with misoprostol | 
| Pain with procedure | Mean pain score (scale 0-10) | 0-12 hours after first misoprostol dose | 
| Side effects | Report of side effects and proportion of participants who experienced each one | 0-12 hours after first misoprostol dose | 
| Satisfaction with procedure | Proportion of participants who reported the procedure as satisfactory or very satisfactory | Prior to discharge from care on day of abortion, up to 12 hours after first misoprostol dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medical abortion, mifepristone