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Sponsors and Collaborators: |
University of Pittsburgh An anonymous Foundation. |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00177372 |
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.
Condition | Intervention | Phase |
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Early Pregnancy Failure Anembryonic Gestation Fetal Demise |
Drug: mifepristone/misoprostol |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Mifepristone and Misoprostol for the Treatment of Early Pregnancy Failure: a Pilot Clinical Trial |
Enrollment: | 30 |
Study Start Date: | January 2005 |
Study Completion Date: | September 2005 |
Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally
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Drug: mifepristone/misoprostol
mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria: healthy hemodynamically stable females with a non-viable pregnancy
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Exclusion Criteria:
United States, Pennsylvania | |
Magee-Womens Hospital | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Mitchell D Creinin, MD | Magee-Womens Hospital |
Responsible Party: | University of Pittsburgh ( MItchell Creinin, MD ) |
Study ID Numbers: | Pittirb0409119 |
Study First Received: | September 12, 2005 |
Last Updated: | October 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00177372 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Contraceptive Agents Hormone Antagonists Contraceptives, Oral Misoprostol Hormones, Hormone Substitutes, and Hormone Antagonists |
Contraceptive Agents, Female Mifepristone Contraceptives, Postcoital Hormones |
Abortifacient Agents, Steroidal Contraceptives, Postcoital, Synthetic Oxytocics Contraceptive Agents Hormone Antagonists Misoprostol Contraceptives, Oral Physiological Effects of Drugs Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female |
Mifepristone Reproductive Control Agents Abortifacient Agents, Nonsteroidal Luteolytic Agents Contraceptives, Postcoital Pharmacologic Actions Therapeutic Uses Anti-Ulcer Agents Abortifacient Agents Menstruation-Inducing Agents Contraceptives, Oral, Synthetic |