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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mifepristone/misoprostol | Drug | mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally |
|
| 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 |
| 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 |
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Inclusion Criteria: healthy hemodynamically stable females with a non-viable pregnancy
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell D Creinin, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17157102 | Result | Schreiber CA, Creinin MD, Reeves MF, Harwood BJ. Mifepristone and misoprostol for the treatment of early pregnancy failure: a pilot clinical trial. Contraception. 2006 Dec;74(6):458-62. doi: 10.1016/j.contraception.2006.07.007. Epub 2006 Sep 7. |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 1-2 weeks |
| to assess the predictors/indicators for successful mifpristone/misoprostol treatment in patients with early pregnancy failure | 1-2 weeks |
| D011083 |
| Polycyclic Compounds |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |