Mifepristone Induction for Fetal Demise

• Status: Terminated
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Montefiore Medical Center
• Treatments: Mifepristone

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