Clinical trial NCT02620904: Mifepristone Induction for Fetal Demise
Official title: Mifepristone Induction for Fetal Demise, a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Intrauterine Fetal Demise
Fetal Death
Keywords: mifepristone
randomized controlled trial
vaginal delivery
progesterone receptor modulator
induction of labor
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 9
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Time to Delivery of Fetus
timeFrame: From the initiation of medical therapy for induction to delivery of fetus, assessed up to 36 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Jessica Atrio, MD
role: PRINCIPAL_INVESTIGATOR
References: