Mifepristone and Misoprostol for Fetal Demise

Study Overview
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Brief Summary
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This is a pilot clinical trial to evaluate whether the medical management of early pregnancy failure with mifepristone and misoprostol is an effective and acceptable treatment. Subjects with early pregnancy failure receive mifepristone followed 24 hours later by vaginal misoprostol for medical management. Subjects then return on study day 3 for a repeat ultrasound to assess passage of pregnancy tissue. subjects who still have a gestational sac present at Day 3 receive a second dose of vaginal misoprostol. All subjects have a follow-up at Day 15, by phone for those who passed the pregnancy with the first dose of misoprostol, and in person for those who received a second dose. Questionnaires are administered at the beginning and end of the study to determine acceptability.

Official Title
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Mifepristone and Misoprostol for the Treatment of Early Pregnancy Failure: a Pilot Clinical Trial

Conditions
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Anembryonic Pregnancy, Gestation Abnormality, Intrauterine Fetal Demise Term

Intervention / Treatment
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* Drug: mifepristone/misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy hemodynamically stable females with a non-viable pregnancy - Exclusion Criteria: orthostatic hypotension, contraindication to either mifepristone or misoprostol, treatment during current pregnancy to provide surgical or medical evacuation of the uterus, evidence of ovarian hyperstimulation syndrome, known or suspected pelvic infection,known or suspected clotting defect or receiving anticoagulants, cardiovascular disease, current breastfeeding, pregnancy with and IUD in situ, current participation in another clinical trial, prior participation in this trial, suspected or confirmed endometrial AV malformation, clinical indication requiring the karyotyping of products of conception

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally | Drug: mifepristone/misoprostol<br>* mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally<br>* Other names: Mifeprix/Cytotec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine if medical management with mifepristone and misoprostol for early pregnancy failure is an effective and acceptable treatment |  | 1-2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate if the treatment of early pregnancy failure with mifepristone and misoprostol is as effective as induced abortion with these medications |  | 1-2 weeks | 
| to assess if mifepristone/misoprostol treatment is acceptable to patients with early pregnancy failure |  | 1-2 weeks | 
| to assess the predictors/indicators for successful mifpristone/misoprostol treatment in patients with early pregnancy failure |  | 1-2 weeks |