Non-surgical Alternatives to Treatment of Failed Medical Abortion

Study Overview
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Brief Summary
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The primary outcome of this study is to compare the effectiveness of a second complete course of 200 mg mifepristone and 800 mcg misoprostol for ongoing pregnancy following mifepristone-misoprostol medical abortion.

Detailed Description
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This is a multi-site double-blind, randomized controlled trial to assess treatment with a repeat mifepristone-misoprostol regimen and with a two-dose misoprostol-alone regimen in women who are diagnosed with ongoing pregnancy ≤77 days gestational age at 1-week follow-up after medical abortion. The sample will be stratified in two cohorts: women with ongoing pregnancies <= 56 days of gestation and women with ongoing pregnancies 57-77 days of gestation. Eligible women who agree to participate in the study will be randomly assigned to either Group 1 for treatment with 200 mg mifepristone followed in 24-48 hours by 800 mcg buccal misoprostol, followed by 4 misoprostol placebo pills 3-12 hours later, or to Group 2 for treatment with one mifepristone placebo pill, followed by 800 mcg buccal misoprostol 24-48 hours later and another 800 mcg dose repeated in 3-12 hours. The study will also assess the acceptability of additional medication for ongoing pregnancy following an initial course of mifepristone-misoprostol medical abortion.

Official Title
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Non-surgical Alternatives to Treatment of Failed Medical Abortion: A Randomized Controlled Double-blind Trial

Conditions
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Abortion Failure

Intervention / Treatment
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* Drug: Mifepristone
* Drug: Misoprostol
* Drug: Placebo mifepristone
* Drug: Placebo misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have ultrasound evidence of an ongoing pregnancy (embryo with cardiac activity) <= 77 days gestational age at follow-up after using a mifepristone-misoprostol regimen for termination of pregnancy Agree to comply with study procedures Able to consent to study participation Exclusion Criteria: Have an ongoing pregnancy but did not take an initial course of mifepristone and misoprostol at the study site Are < 18 years old in US and Canadian sites Present with other medical abortion outcomes including persistent non-viable pregnancies or empty sac Are unable to provide contact information for follow-up purposes

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mifepristone-misoprostol<br>Women randomized to receive 200 mg mifepristone to take on Day 1, 800 mcg buccal misoprostol to take 24-48 hours after later, and four placebo misoprostol pills to take a further 3-12 hours later. | Drug: Mifepristone<br>* 200mg oral mifepristone<br>* Other names: Mifeprex;Drug: Misoprostol<br>* 800mcg buccal misoprostol<br>* Other names: Cytotec;Drug: Placebo misoprostol<br>* Matching placebo pills of 800mcg misoprostol<br>|
| Experimental: Misoprostol-misoprostol<br>Women randomized to receive a placebo mifepristone pill to take on Day 1 and two doses of 800 mcg buccal misoprostol, the first of which should be taken 24-48 hours after the placebo and the second of which should be taken 3-12 hours after the first misoprostol dose. | Drug: Misoprostol<br>* 800mcg buccal misoprostol<br>* Other names: Cytotec;Drug: Placebo mifepristone<br>* Matching placebo pill of 200mg mifepristone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of women in each study group, by gestational age cohort, who have a successful abortion without recourse to surgical intervention for any reason. |  | One week after taking first study medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of women in each arm by gestational age cohort with resolved ongoing pregnancies following study treatment, regardless of surgical intervention |  | One week after taking first study medication | 
| The proportion of women who found medical treatment to be an acceptable method to treat ongoing pregnancy, as measured by a follow up questionnaire |  | One week after taking first study medication | 

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