Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly (STOP BLOQ)

Recruiting now · Phase 3

Conditions studied: AVB - Atrioventricular Block, Fetal AVB

In brief

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 maternal anti-Ro autoantibodies and results in death in a fifth of cases. To date treatment of 3° AVB has been ineffective in restoring normal rhythm (NR) which may be because current surveillance is limited to once- weekly fetal echocardiograms. It is hypothesized that there may be a vital transition period of several hours in which incomplete block (2° AVB) may be successfully treated avoiding fully advanced irreversible 3° AVB. To optimize the likelihood of timely detection of the transition period this study comprises three steps: 1) to risk stratify for high titer anti-Ro antibodies, which are necessary but not sufficient to develop fetal AVB; 2) to empower mothers to identify 2° AVB by using fetal heart rate and rhythm monitoring (FHRM) at home, and 3) to rapidly treat mothers who detect an abnormality by monitoring with an urgent echocardiogram that confirms 2° AVB with the hope of reversing 2° AVB before it becomes permanent (3° AVB). In addition, it will be determined if FHRM reduces the need for weekly echoes. Although mothers with low titer anti-Ro will not be continued in Step 2 and therefore not followed by FHRM, birth ECGs will be collected to confirm that low titer antibodies do not confer risk. It is anticipated that this study will provide an evidenced based surveillance strategy for those mothers at high risk of having a child with 3° AVB.

Key facts

Study ID

NCT04474223

Run by

NYU Langone Health

People needed

1300

Starts

2020-08-01

Expected to finish

2029-06-30

Last updated by the study team

2026-04-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Phoenix Children's Hospital/Dignity Health — Phoenix, Arizona, United States (enrolling)
• University of California - Los Angeles (UCLA) — Los Angeles, California, United States (enrolling)
• Stanford University — Palo Alto, California, United States (enrolling)
• University of California-San Francisco — San Francisco, California, United States (enrolling)
• University of Colorado, Denver (UCD) — Aurora, Colorado, United States (enrolling)
• Yale University School of Medicine — New Haven, Connecticut, United States (enrolling)
• Children's National Medical Center/George Washington University — Washington D.C., District of Columbia, United States (enrolling)
• University of Kentucky / Kentucky Children's Hospital — Lexington, Kentucky, United States (enrolling)
• University of Utah Health — Salt Lake City, Utah, United States (enrolling)
• University of Vermont Children's Hospital — Burlington, Vermont, United States (enrolling)
• Eastern Virginia Medical School (EVMS) — Norfolk, Virginia, United States (enrolling)
• University of Michigan / C. S. Mott Children's Hospital — Ann Arbor, Michigan, United States (enrolling)
• Children's Hospital of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Perinatal Associates of New Mexico — Rio Rancho, New Mexico, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• Mount Sinai — New York, New York, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• UH Rainbow Babies / Children's Hospital — Cleveland, Ohio, United States (enrolling)
• Cleveland Clinic Lerner College of Medicine — Cleveland, Ohio, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• Baylor College of Medicine — Houston, Texas, United States (enrolling)
• University of Louisville / Norton Children's Hospital — Louisville, Kentucky, United States
• Stollery Children's Hospital — Edmonton, Alberta, Canada
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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