Anembryonic Pregnancy, Gestation Abnormality, Intrauterine Fetal Demise Term
Conditions
Brief 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.
Interventions
DRUGmifepristone/misoprostol
mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally
Sponsors
University of Pittsburgh
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed