Mifepristone and Misoprostol for Fetal Demise

Anembryonic Pregnancy Clinical Trial

— MIMID  

Official title:

Mifepristone and Misoprostol for the Treatment of Early Pregnancy Failure: a Pilot Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00177372
• Other study ID #: Pittirb0409119
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: January 28, 2016
• Start date: January 2005
• Est. completion date: September 2005

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anembryonic Pregnancy
• Fetal Death
• Gestation Abnormality
• Intrauterine Fetal Demise Term

Intervention

Drug:
• mifepristone/misoprostol
mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally

Locations

Country	Name	City	State
United States	Magee-Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epub 2006 Sep 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to determine if medical management with mifepristone and misoprostol for early pregnancy failure is an effective and acceptable treatment		1-2 weeks	No
Secondary	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	No
Secondary	to assess if mifepristone/misoprostol treatment is acceptable to patients with early pregnancy failure		1-2 weeks	No
Secondary	to assess the predictors/indicators for successful mifpristone/misoprostol treatment in patients with early pregnancy failure		1-2 weeks	No