Outpatient Medical Abortion With Mifepristone and Misoprostol Through 77 Days of Gestation

Study Overview
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Brief Summary
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To demonstrate non-inferiority of the efficacy of 200 mg mifepristone followed in 24 to 48 hours by 800 µg buccal misoprostol in outpatient medical abortion services among women 71-77 days' compared to women 64-70 days' LMP.

Official Title
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Outpatient Medical Abortion With Mifepristone and Misoprostol Through 77 Days of Gestation: A Non-inferiority Trial

Conditions
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Medical Abortion

Intervention / Treatment
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* Drug: Mifepristone followed by misoprostol 24-48 hours later


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: intrauterine pregnancy between 64 days and 77 days' LMP eligible for medical abortion according to study doctor assessment willing and able to sign consent form speak english or spanish (in US sites); speak the local language(s) (in international sites) agree to comply with the study procedures and visit schedule Exclusion Criteria: Have known allergies or present other contraindications to mifepristone or misoprostol

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 |
| --- | --- |
| Experimental: 71-77 days gestational age<br>Women whose pregnancies are estimated to have a gestational age of 71-77 days. | Drug: Mifepristone followed by misoprostol 24-48 hours later<br>* 200mg oral mifepristone and 800mcg buccal misoprostol 24-48 hours after mifepristone<br>|
| No Intervention: 64-70 days gestational age<br>Women whose pregnancies are estimated to have a gestational age of 64-70 days.( Women in this arm receive the standard of care for medical termination of pregnancy in the stated gestational age range). | |

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 terminations without surgical intervention (suction curettage or D&C) for any reason | Efficacy of medical abortion in the later first trimester as determined by the proportion of successful terminations without surgical intervention (suction curettage or D&C) for any reason | 7-36 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Individual Side Effects Experienced by Participants | Side effects include diarrhea, nausea, vomiting, fever, chills, headaches, dizziness and/or weakness experienced by participants | 7-14 days | 
| Proportion of Women Who Determine Method Acceptable | overall acceptability, time to complete abortion, bleeding, side effects, pain | 7-14 days | 
| Proportion of Providers Who Determine Method Acceptable | As assessed by service provider semi-structured interviews | 7-36 days |