Mifepristone Induction for Fetal Demise

NCT02620904 | Terminated Phase 4 Results DMC

• 1 other identifier: 2015-5689
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrauterine Fetal Demise; Fetal Death

Keywords

mifepristone; randomized controlled trial; vaginal delivery; progesterone receptor modulator; induction of labor

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

mifepristone

ACTIVE COMPARATOR

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

Drug: Mifepristone

placebo pill

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Mifepristone DRUG

Also known as: RU486, RU46, mifeprex, mifegen

mifepristone

placebo DRUG

placebo pill

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Intrauterine fetal death as confirmed by absence of cardiac motion on ultrasound by Attending physician at the time of admission to the hospital.
• Estimated gestational age greater than 20 weeks
• Hemodynamically stable and appropriate for induction of labor as per primary clinical health team in house
• Women with one prior low transverse cesarean delivery

You may not qualify if:

• History of 2 or more low transverse cesarean deliveries
• Prior classical cesarean delivery
• History of abdominal myomectomy
• Known or suspected allergic reaction to mifepristone
• Known or suspected adrenal gland disease
• Known or suspected bleeding diatheses or coagulopathies
• Known or suspected use of QTc-prolonging medication
• Known maternal medical or physical conditions that prohibits vaginal delivery

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Stillbirth; Fetal Death

Interventions

Mifepristone

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Due to difficulty with recruitment the study was unable to be completed in the projected time frame. Despite efforts to enhance recruitment and extending the study duration very few persons were enrolled. Due to the limited enrollment no conclusions can be ascertained about the impact of mifepristone on the induction of labor in this setting.

Results Point of Contact

• Title: Jessica Maria Atrio
• Organization: Montefiore Einstein

jatrio@montefiore.org

7184058260

Study Officials

• Jessica Atrio, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 3, 2015
• Study Start: July 14, 2016
• Primary Completion: October 1, 2019
• Study Completion: January 1, 2020
• Last Updated: February 18, 2021
• Results First Posted: February 18, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)