Mifepristone Induction for Fetal Demise (MIFD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02620904|
Recruitment Status : Recruiting
First Posted : December 3, 2015
Last Update Posted : October 17, 2016
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
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
- time to delivery of fetus [ Time Frame: from the initiation of medical therapy for induction to delivery of fetus ]
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
|Contact: Jessica Atrio, MD||718 405 firstname.lastname@example.org|
|Contact: Nerys Benfield, MDemail@example.com|
|United States, New York|
|Montefiore Medical Center||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Jessica Atrio, MD 718-405-8260 firstname.lastname@example.org|
|Contact: Nerys Benfield, MD 7184058260 email@example.com|
|Principal Investigator:||Jessica Atrio, MD||Montefiore Medical Center|