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Mifepristone Induction for Fetal Demise (MIFD)

Primary Purpose

Intrauterine Fetal Demise, Fetal Death

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Mifepristone
placebo
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intrauterine Fetal Demise focused on measuring mifepristone, randomized controlled trial, vaginal delivery, progesterone receptor modulator, induction of labor

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Intrauterine fetal death as confirmed by absence of cardiac motion on ultrasound by Attending physician at the time of admission to the hospital.
  2. Estimated gestational age greater than 20 weeks
  3. Hemodynamically stable and appropriate for induction of labor as per primary clinical health team in house
  4. Women with one prior low transverse cesarean delivery

Exclusion Criteria:

  1. History of 2 or more low transverse cesarean deliveries
  2. Prior classical cesarean delivery
  3. History of abdominal myomectomy
  4. Known or suspected allergic reaction to mifepristone
  5. Known or suspected adrenal gland disease
  6. Known or suspected bleeding diatheses or coagulopathies
  7. Known or suspected use of QTc-prolonging medication
  8. Known maternal medical or physical conditions that prohibits vaginal delivery

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

mifepristone

placebo pill

Arm Description

following informed consent women will be randomized and the mifepristone group will take 200 mg by mouth immediately prior to induction of labor for fetal demise on labor and delivery

following informed consent women will be randomized and the placebo group will take a placebo pill by mouth (similar in properties to the mifepristone group, but it will lack any active drug) immediately prior to induction of labor for fetal demise on labor and delivery

Outcomes

Primary Outcome Measures

Time to Delivery of Fetus
From the initiation of medical therapy for induction to delivery of fetus, assessed up to 36 hours

Secondary Outcome Measures

Full Information

First Posted
December 1, 2015
Last Updated
January 30, 2021
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02620904
Brief Title
Mifepristone Induction for Fetal Demise
Acronym
MIFD
Official Title
Mifepristone Induction for Fetal Demise, a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
unable to recruit. Projected completion was 2018 however, enrollment and recruitment were difficult. The study was terminated due to inability to enroll.
Study Start Date
July 14, 2016 (Actual)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Methods: Double blinded, randomized controlled trial with 1:1 allocation of mifepristone or placebo at initiation of induction of labor for fetal demise 20 weeks estimated gestational age or greater. Hypothesis: Mifepristone will expedite time to delivery of fetus among demise patients, when compared to placebo, and in conjunction with other pharmacologic methods for induction of labor. Expected outcomes: The addition of a progesterone receptor modulator will expedite time to delivery of the fetus and ultimately improve the experience associated with induction of labor for fetal demise.
Detailed Description
The investigators propose a double blinded, randomized, placebo-controlled clinical trial at the time of initiation of induction of labor for fetal demise at 20 weeks gestational age or greater. Diagnose fetal demise: confirm absence of fetal heart motion by attending physician as per the institutional standards and protocols. Confirm gestational age at presentation to labor and delivery based on available medical records and/or ultrasonography as per standard practice and institutional protocols. Based on inclusion and exclusion criteria potential participants will be informed about the research, offered the opportunity to contribute, and trained research staff will complete the informed consent process. After documentation of consent and discussion of the research as indicated the participants will be randomized to the intervention or control arm. Both groups will receive emotional and physical support with induction of labor as per practice guidelines and standard of care by Montefiore physicians, faculty and staff irrespective of participation or assignment. Interventional Arm: Ingest 200mg tab of mifepristone orally. This will coincide with or be implemented prior to the initiation of the induction of labor plan as delineated by the attending physician. The timing will be sensitive to the needs of the participant and the labor and delivery room staff. Control Arm: Ingest a placebo tab orally with similar physical properties. This will coincide with or be implemented prior to the initiation of the induction of labor plan as delineated by the attending physician. The timing will be sensitive to the needs of the participant and the labor and delivery room staff. Montefiore protocol for induction of labor: will follow institutional standards. Data: Patient data will be collected by the Labor and Delivery staff via electronic medical record or paper record that will be scanned into the electronic medical record. The investigators will use data abstraction tools to collect information such as time of medication administration, medications administered, time of delivery of fetus, duration of admittance to labor and delivery, and postpartum course, or complications from the electronic medical record.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Fetal Demise, Fetal Death
Keywords
mifepristone, randomized controlled trial, vaginal delivery, progesterone receptor modulator, induction of labor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mifepristone
Arm Type
Active Comparator
Arm Description
following informed consent women will be randomized and the mifepristone group will take 200 mg by mouth immediately prior to induction of labor for fetal demise on labor and delivery
Arm Title
placebo pill
Arm Type
Placebo Comparator
Arm Description
following informed consent women will be randomized and the placebo group will take a placebo pill by mouth (similar in properties to the mifepristone group, but it will lack any active drug) immediately prior to induction of labor for fetal demise on labor and delivery
Intervention Type
Drug
Intervention Name(s)
Mifepristone
Other Intervention Name(s)
RU486, RU46, mifeprex, mifegen
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Time to Delivery of Fetus
Description
From the initiation of medical therapy for induction to delivery of fetus, assessed up to 36 hours
Time Frame
From the initiation of medical therapy for induction to delivery of fetus, assessed up to 36 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Intrauterine fetal death as confirmed by absence of cardiac motion on ultrasound by Attending physician at the time of admission to the hospital. Estimated gestational age greater than 20 weeks Hemodynamically stable and appropriate for induction of labor as per primary clinical health team in house Women with one prior low transverse cesarean delivery Exclusion Criteria: History of 2 or more low transverse cesarean deliveries Prior classical cesarean delivery History of abdominal myomectomy Known or suspected allergic reaction to mifepristone Known or suspected adrenal gland disease Known or suspected bleeding diatheses or coagulopathies Known or suspected use of QTc-prolonging medication Known maternal medical or physical conditions that prohibits vaginal delivery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Atrio, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Mifepristone Induction for Fetal Demise

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