Mifepristone and Misoprostol for Fetal Demise
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2005 |
| End Date: | September 2005 |
Mifepristone and Misoprostol for the Treatment of Early Pregnancy Failure: a Pilot Clinical Trial
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.
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.
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
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