Mifepristone and Two Doses of Misoprostol for Abortion at 11&12 Weeks

Study Overview
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Brief Summary
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This study seeks to evaluate the efficacy, side effect profile and acceptability of a medical abortion regimen with mifepristone and two doses of 800 mcg misoprostol buccally at 71-77 and 78-84 days of gestation to further expand the evidence base for the most effective regimens in the late first trimester of pregnancy.

Official Title
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An Outpatient Medical Abortion Regimen With Mifepristone and Two Doses of Misoprostol at 71-77 and 78-84 Days of Pregnancy

Conditions
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Medical Abortion

Intervention / Treatment
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* Drug: Mifepristone + 2 doses of misoprostol 800 mcg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Seeking medical abortion services at one of the enrolling clinics Have an intrauterine pregnancy 71-77 days of gestation or 78-84 days Meet standard eligibility criteria for medical abortion Be able to return to clinic for in-person follow up Speak/read/write English or Spanish Have access to a mobile phone with texting capability Be in general good health Be willing and able to sign consent forms Agree to comply with the study procedures and follow up. Exclusion Criteria: Not eligible to consent on their own to being in a study (Age criteria may vary by site according to state law.) With known allergies or other contraindications to mifepristone or misoprostol Desiring to start depot medroxyprogesterone acetate (DMPA) as contraception method immediately because of potential interaction with mifepristone. Those who wish to wait until abortion completion to start DMPA will be eligible for enrollment.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 55 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 71-77 days of gestational age<br>Pregnant people whose pregnancies are estimated to have a gestational age of 71-77 days. (Participants in this arm receive the standard of care for medical termination of pregnancy in the stated gestational age range). | |
| Experimental: 78-84 days of gestational age<br>Pregnant people whose pregnancies are estimated to have a gestational age of 78-84 days. | Drug: Mifepristone + 2 doses of misoprostol 800 mcg<br>* Will use a mifepristone-misoprostol regimen of: 200 mg mifepristone followed in 24-48 hours by a first dose of 800 µg misoprostol buccally and then in another 4 hours by a second dose of 800 µg misoprostol buccally. For buccal administration of misoprostol, participants will place 2 misoprostol tablets in each cheek and hold them for 20-30 minutes, after which they will swallow any remnants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as determined by the proportion of successful abortions without aspiration or D&E for any reason | Proportion of women who achieve complete abortion with medication only and without aspiration or D&E | 7-36 days after initial visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who report each individual side effect | Side effects include diarrhea, nausea, vomiting, fever, chills | 7-14 days after initial visit | 
| Proportion of complications experienced by participants that warrant visits to emergency room and/or hospitalization | Complications could include abnormal bleeding, severe pain, retained tissue | 7-14 days after initial visit | 
| Proportion of participants who determine method acceptable | Overall acceptability, time to complete abortion, bleeding, side effects, pain | 7-36 days after initial visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mifepristone, misoprostol, first trimester, abortion