Mifepristone Induction for Fetal Demise (MIFD)

January 30, 2021 updated by: Jessica Atrio, Montefiore Medical Center

Mifepristone Induction for Fetal Demise, a Randomized Control Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

  1. Diagnose fetal demise: confirm absence of fetal heart motion by attending physician as per the institutional standards and protocols.
  2. Confirm gestational age at presentation to labor and delivery based on available medical records and/or ultrasonography as per standard practice and institutional protocols.
  3. 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.
  4. 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.
  5. 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.
  6. Montefiore protocol for induction of labor: will follow institutional standards.
  7. 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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: mifepristone
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
Drug: Mifepristone
Other Names:
  • RU486, RU46, mifeprex, mifegen
Placebo Comparator: placebo pill
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
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Delivery of Fetus
Time Frame: From the initiation of medical therapy for induction to delivery of fetus, assessed up to 36 hours
From the initiation of medical therapy for induction to delivery of fetus, assessed up to 36 hours
From the initiation of medical therapy for induction to delivery of fetus, assessed up to 36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Jessica Atrio, MD, Montefiore Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2016

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

December 2, 2015

First Posted (Estimate)

December 3, 2015

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

January 30, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-5689

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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