Fetal Death, Intrauterine Fetal Demise
Conditions
Keywords
mifepristone, randomized controlled trial, vaginal delivery, progesterone receptor modulator, induction of labor
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.
Interventions
DRUGMifepristone
DRUGplacebo
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Delivery of Fetus | From the initiation of medical therapy for induction to delivery of fetus, assessed up to 36 hours | From the initiation of medical therapy for induction to delivery of fetus, assessed up to 36 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
Mifepristone | 4 |
| 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
placebo | 5 |
| Total | 9 |
Baseline characteristics
| Characteristic | Placebo Pill | Total | Mifepristone |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 9 Participants | 4 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 5 participants | 9 participants | 4 participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 5 |
| other Total, other adverse events | 0 / 4 | 0 / 5 |
| serious Total, serious adverse events | 0 / 4 | 0 / 5 |
Outcome results
Primary
Time to Delivery of Fetus
From the initiation of medical therapy for induction to delivery of fetus, assessed up to 36 hours
Time frame: From the initiation of medical therapy for induction to delivery of fetus, assessed up to 36 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mifepristone | Time to Delivery of Fetus | 14 hours |
| Placebo Pill | Time to Delivery of Fetus | 20 hours |