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Mifepristone and Misoprostol for Fetal Demise (MIMID)

Primary Purpose

Anembryonic Pregnancy, Gestation Abnormality, Intrauterine Fetal Demise Term

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
mifepristone/misoprostol
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anembryonic Pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Magee-Womens Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally

Outcomes

Primary Outcome Measures

to determine if medical management with mifepristone and misoprostol for early pregnancy failure is an effective and acceptable treatment

Secondary Outcome Measures

to evaluate if the treatment of early pregnancy failure with mifepristone and misoprostol is as effective as induced abortion with these medications
to 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

Full Information

First Posted
September 12, 2005
Last Updated
January 28, 2016
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT00177372
Brief Title
Mifepristone and Misoprostol for Fetal Demise
Acronym
MIMID
Official Title
Mifepristone and Misoprostol for the Treatment of Early Pregnancy Failure: a Pilot Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anembryonic Pregnancy, Gestation Abnormality, Intrauterine Fetal Demise Term

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally
Intervention Type
Drug
Intervention Name(s)
mifepristone/misoprostol
Other Intervention Name(s)
Mifeprix/Cytotec
Intervention Description
mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally
Primary Outcome Measure Information:
Title
to determine if medical management with mifepristone and misoprostol for early pregnancy failure is an effective and acceptable treatment
Time Frame
1-2 weeks
Secondary Outcome Measure Information:
Title
to evaluate if the treatment of early pregnancy failure with mifepristone and misoprostol is as effective as induced abortion with these medications
Time Frame
1-2 weeks
Title
to assess if mifepristone/misoprostol treatment is acceptable to patients with early pregnancy failure
Time Frame
1-2 weeks
Title
to assess the predictors/indicators for successful mifpristone/misoprostol treatment in patients with early pregnancy failure
Time Frame
1-2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell D Creinin, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17157102
Citation
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. doi: 10.1016/j.contraception.2006.07.007. Epub 2006 Sep 7.
Results Reference
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Mifepristone and Misoprostol for Fetal Demise

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