Preventing fetal atrioventricular block through enhanced monitoring and treatment

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

This study is testing whether better monitoring and treatment can help pregnant women with certain antibodies prevent their babies from developing a serious heart condition.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1300 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: NYU Langone Health (Academic / other)
• Drugs / interventions: prednisone
• Locations: 24 sites (Phoenix, Arizona and 23 other locations)
• Trial ID: NCT04474223 on ClinicalTrials.gov

What this trial studies

This study aims to prevent fetal complete atrioventricular block (AVB) by improving monitoring and treatment strategies for pregnant women with anti-Ro autoantibodies. It involves risk stratification for high titer anti-Ro antibodies, empowering mothers to monitor fetal heart rate and rhythm at home, and providing rapid treatment for those who detect early signs of AVB. The goal is to identify a critical transition period where treatment may be effective in preventing the progression to irreversible AVB. The study will utilize interventions such as dexamethasone and IVIG to address the condition.

Who should consider this trial

Good fit: Ideal candidates are pregnant women under 18 weeks gestation with high titer anti-Ro antibodies or a history of a previously affected child.

Not a fit: Patients with multi-fetal pregnancies or known allergies to the study medications will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of fetal AVB and improve outcomes for affected pregnancies.

How similar studies have performed: While the approach of enhanced monitoring and early intervention is innovative, similar studies have not been widely conducted, making this a novel investigation.

Eligibility criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Be \<18 weeks pregnant at the time of enrollment
4. Titer of anti-Ro 52 or 60 antibodies ≥1,000 EU
5. Any positive titer of anti-Ro if a history of a previously affected child
6. Ability to take oral medication and be willing to adhere to the dexamethasone and IVIG protocols.
7. Ability to perform Doppler fetal heart rate and rhythm monitoring in the ambulatory setting,
8. 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
9. Be ≥18 years of age

Exclusion Criteria:

1. Multi-fetal pregnancy
2. Known allergic reactions to components of IVIG, or dexamethasone or maternal IgA deficiency
3. Fetal conduction system disease already present in the current pregnancy
4. 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
5. Women prisoners
6. Treatment with \>20 mg/prednisone q day or with any dose of fluorinated steroids at enrollment

Where this trial is running

Phoenix, Arizona and 23 other locations

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

Study contacts

• Principal investigator: Jill Buyon, MD — NYU Langone Health
• Study coordinator: Mala Masson

Conditions AVB - Atrioventricular Block; Fetal AVB