Study of 400mcg Versus 800mcg Buccal Misoprostol Following Mifepristone 200mg for Abortion up to 63 Days Gestation

Study Overview
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Brief Summary
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This double-blind, randomized study will compare the efficacy and acceptability of mifepristone 200mg followed in 36-48 hours by 400mcg or 800mcg of buccal misoprostol (i.e., in the cheeks) for termination of pregnancy in women up to 63 days LMP.

Detailed Description
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The goal of this study is to provide answers to the following four questions: Is a regimen of medical abortion with mifepristone using 400mcg buccal misoprostol as effective and acceptable as using 800mcg buccal misoprostol up to 63 days since the last menstrual period (LMP)? Are the side effects with buccal use tolerable for women? Is buccal administration of misoprostol acceptable to women? When given a choice, do women prefer to take misoprostol at home or in the clinic?

Conditions
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Induced Abortion

Intervention / Treatment
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* Drug: Mifepristone, misoprostol
* Drug: mifepristone, misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 18 years or over presenting for abortion services who consent to participate good general health assessed by a clinician to have an intrauterine pregnancy less than 64 days LMP on Study Day 1 and to be eligible for medical abortion Have ready access to a telephone and emergency transportation; Be willing to provide an address and/or telephone number for purposes of follow-up Exclusion Criteria: Conditions which contraindicate the use of mifepristone or misoprostol Women presenting for medical abortion who do not consent to participate

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>200mg mifepristone followed by 400mcg misoprostol | Drug: Mifepristone, misoprostol<br>* 200mg mifepristone followed by 400mcg misoprostol 36-48 hours later<br>|
| Active Comparator: 2<br>200mg mifepristone followed by 800mcg misoprostol | Drug: mifepristone, misoprostol<br>* 200mg mifepristone followed by 800mcg misoprostol 36-48 hours later<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for surgical completion for ongoing viable pregnancies at follow up visit (Study day 12-15) or for incomplete abortion at extended follow up visit (Study day (19-22). |  | Study day 12-15 for ongoing viable pregnancies or Study day 19-22 for incomplete abortion at extended follow up visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side-effects, acceptability for women |  | side effects and acceptability recorded at exit interview | 

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