Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-02 @ 12:09 PM
Study NCT ID:
NCT02620904
Status:
TERMINATED
Last Update Posted:
2021-02-18
First Post:
2015-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mifepristone Induction for Fetal Demise
Sponsor:
Montefiore Medical Center
Organization:
Study Overview
Official Title:
Mifepristone Induction for Fetal Demise, a Randomized Control Trial
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
unable to recruit. Projected completion was 2018 however, enrollment and recruitment were difficult. The study was terminated due to inability to enroll.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIFD
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.
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: