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Mifepristone Induction for Fetal Demise (MIFD)

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ClinicalTrials.gov Identifier: NCT02620904
Recruitment Status : Recruiting
First Posted : December 3, 2015
Last Update Posted : October 17, 2016
Sponsor:
Information provided by (Responsible Party):
Montefiore Medical Center

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.


Condition or disease Intervention/treatment Phase
Intrauterine Fetal Demise Fetal Death Drug: Mifepristone Drug: placebo Phase 4

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  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mifepristone Induction for Fetal Demise, a Randomized Control Trial
Study Start Date : February 2016
Estimated Primary Completion Date : September 2018
Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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



Primary Outcome Measures :
  1. time to delivery of fetus [ Time Frame: from the initiation of medical therapy for induction to delivery of fetus ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620904


Contacts
Contact: Jessica Atrio, MD 718 405 8260 jatrio@montefiore.org
Contact: Nerys Benfield, MD 7184058260 nbenfiel@montefiore.org

Locations
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Jessica Atrio, MD    718-405-8260    jatrio@montefiore.org   
Contact: Nerys Benfield, MD    7184058260    nbenfiel@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Jessica Atrio, MD Montefiore Medical Center

Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02620904     History of Changes
Other Study ID Numbers: 2015-5689
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Montefiore Medical Center:
mifepristone
randomized controlled trial
vaginal delivery
progesterone receptor modulator
induction of labor

Additional relevant MeSH terms:
Fetal Death
Stillbirth
Pregnancy Complications
Death
Pathologic Processes
Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents