Status:
RECRUITING
Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly (STOP BLOQ)
Lead Sponsor:
NYU Langone Health
Conditions:
AVB - Atrioventricular Block
Fetal AVB
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Fetal complete (i.e., third degree, 3°) atrioventricular block (AVB), identified in the 2nd trimester of pregnancy in an otherwise normally developing heart, is almost universally associated with mate...
Detailed Description
Fetal complete (3°) atrioventricular block (AVB), identified in the 2nd trimester in an otherwise normally developing heart, is almost universally associated with maternal anti-Ro autoantibodies, whic...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Be \<18 weeks pregnant at the time of enrollment
- Titer of anti-Ro 52 or 60 antibodies ≥1,000 EU
- Any positive titer of anti-Ro if a history of a previously affected child
- Ability to take oral medication and be willing to adhere to the dexamethasone and IVIG protocols.
- Ability to perform Doppler fetal heart rate and rhythm monitoring in the ambulatory setting,
- Ability to send an audiotext message by cell phone therefore the participant will be informed that they need a phone with texting capabilities. Located within 6 hours drive of the participating pediatric cardiology site
- Be ≥18 years of age
Exclusion
- Multi-fetal pregnancy
- Known allergic reactions to components of IVIG, or dexamethasone or maternal IgA deficiency
- Fetal conduction system disease already present in the current pregnancy
- Any women who in the opinion of the investigator cannot understand the consent form or be able to perform thrice daily home monitoring or recognize an abnormal fetal heart rate or rhythm
- Women prisoners
- Treatment with \>20 mg/prednisone q day or with any dose of fluorinated steroids at enrollment
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT04474223
Start Date
August 1 2020
End Date
June 30 2029
Last Update
April 9 2025
Active Locations (24)
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1
Phoenix Children's Hospital/Dignity Health
Phoenix, Arizona, United States, 85016
2
University of California - Los Angeles (UCLA)
Los Angeles, California, United States, 90095
3
Stanford University
Palo Alto, California, United States, 94305
4
University of California-San Francisco
San Francisco, California, United States, 94143