Mifepristone Induction for Fetal Demise

NCT ID: NCT02620904

Last Updated: 2021-02-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-14
• Study Completion Date: 2020-01-31

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.

Conditions

Intrauterine Fetal Demise; Fetal Death

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Mifepristone

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

Mifepristone

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Other Intervention Names

RU486, RU46, mifeprex, mifegen

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jessica Atrio

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica Atrio, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2015-5689

Identifier Type: -

Identifier Source: org_study_id