Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02620904 |
| Other study ID # |
2015-5689 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
July 14, 2016 |
| Est. completion date |
January 2020 |
Study information
| Verified date |
January 2021 |
| Source |
Montefiore Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
