MIFD: Mifepristone Induction for Fetal Demise

• Sponsor: Montefiore Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02620904
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arms: 2
• Actual Duration (Months): 41.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intrauterine Fetal Demise; Fetal Death	Drug: Mifepristone; Drug: placebo	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Mifepristone Induction for Fetal Demise, a Randomized Control Trial
• Actual Study Start Date: Jul 14, 2016
• Actual Primary Completion Date: Oct 1, 2019
• Actual Study Completion Date: Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Drug: Mifepristone; Other Names: RU486, RU46, mifeprex, mifegen
Placebo Comparator: 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	Drug: placebo

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10461

Sponsors and Collaborators

• Montefiore Medical Center

Investigators

• Principal Investigator: Jessica Atrio, MD, Montefiore Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 11, 2016
• Informed Consent Form - Feb 11, 2016

More Information

Publications

None provided.

• Responsible Party: Jessica Atrio, principal investigator, Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT02620904
• Other Study ID Numbers: 2015-5689
• First Posted: Dec 3, 2015
• Last Update Posted: Feb 18, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Jessica Atrio, principal investigator, Montefiore Medical Center: mifepristone; randomized controlled trial; vaginal delivery; progesterone receptor modulator; induction of labor
• Additional relevant MeSH terms: Fetal Death; Stillbirth; Mifepristone

Study Results

Participant Flow

Arm/Group Title	Mifepristone	Placebo Pill
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	4	5
COMPLETED	4	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Mifepristone	Placebo Pill	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	4	5	9
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	4 100%	5 100%	9 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	4 100%	5 100%	9 100%
Male	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	4 100%	5 100%	9 100%

Outcome Measures

1. Primary Outcome

Title	Time to Delivery of Fetus
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mifepristone	Placebo Pill
Arm/Group Description	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	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
Measure Participants	4	5
Mean (Full Range) [hours]	14	20

Adverse Events

Time Frame	Adverse events were assessed during hospitalization, an average of 3 days
Arm/Group Title	Mifepristone		Placebo Pill
Arm/Group Description	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		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
All Cause Mortality
	Mifepristone		Placebo Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/5 (0%)
Serious Adverse Events
	Mifepristone		Placebo Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Mifepristone		Placebo Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/5 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.