Mifepristone and Misoprostol for Fetal Demise
Information source: University of Pittsburgh
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Early Pregnancy Failure; Anembryonic Gestation; Fetal Demise
Intervention: mifepristone/misoprostol (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Pittsburgh Official(s) and/or principal investigator(s): Mitchell D Creinin, MD, Principal Investigator, Affiliation: Magee-Womens Hospital
Summary
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.
Clinical Details
Official title: Mifepristone and Misoprostol for the Treatment of Early Pregnancy Failure: a Pilot Clinical Trial
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: to determine if medical management with mifepristone and misoprostol for early pregnancy failure is an effective and acceptable treatment
Secondary outcome: to evaluate if the treatment of early pregnancy failure with mifepristone and misoprostol is as effective as induced abortion with these medicationsto assess if mifepristone/misoprostol treatment is acceptable to patients with early pregnancy failure to assess the predictors/indicators for successful mifpristone/misoprostol treatment in patients with early pregnancy failure
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria: healthy hemodynamically stable females with a non-viable pregnancy
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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
Locations and Contacts
Magee-Womens Hospital, Pittsburgh, Pennsylvania 15213, United States
Additional Information
Starting date: January 2005
Last updated: October 20, 2008
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