Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly (STOP BLOQ)
1 other identifier
interventional
1,300
2 countries
24
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2020
Longer than P75 for phase_3
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2020
CompletedFirst Posted
Study publicly available on registry
July 16, 2020
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
April 9, 2025
April 1, 2025
8.4 years
July 14, 2020
April 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of 2° AVB subjects with NR (1:1 AV conduction) at birth
The presence of NR (normal rhythm) will be determined by electrocardiogram (ECG)
up to 25 weeks post-enrollment
Secondary Outcomes (3)
Percentage of 2° AVB subjects who maintain NR at age 1 year.
1 year post-birth
Percentage of AV interval > 170 msec subjects with NR at birth
At birth
Incidences of isolated extra-nodal cardiac disease
up to 1 year post-birth
Study Arms (1)
Mothers with Fetuses Who Have 2° AVB or AV interval > 170ms
EXPERIMENTALInterventions
In mother in whom 2° AVB or AV interval \>170 ms has been diagnosed in the fetus: Dexamethasone 8 mg po/day for 10 days. Then dexamethasone 4 mg po/ day through 28 weeks 6 days gestational age (GA); then 3 mg/day from 29 wks 0 days to 29 wks 6 days GA; then 2 mg/day until delivery
In a mother in whom 2° AVB has been diagnosed in the fetus: One dose of IVIG \[1g/kg of maternal weight (max dose 70 g)\] at diagnosis of 2° AVB (within 12 hours of detection by mother via home monitoring and within 6 hours of confirmation by echocardiogram). A fetal AV interval \> 170 ms will not be treated with maternal IVIG, only dexamethasone.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Phoenix Children's Hospital/Dignity Health
Phoenix, Arizona, 85016, United States
University of California - Los Angeles (UCLA)
Los Angeles, California, 90095, United States
Stanford University
Palo Alto, California, 94305, United States
University of California-San Francisco
San Francisco, California, 94143, United States
University of Colorado, Denver (UCD)
Aurora, Colorado, 80204, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Children's National Medical Center/George Washington University
Washington D.C., District of Columbia, 20010, United States
University of Kentucky / Kentucky Children's Hospital
Lexington, Kentucky, 40536, United States
University of Louisville / Norton Children's Hospital
Louisville, Kentucky, 40202, United States
University of Michigan / C. S. Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Children's Hospital of Minnesota
Minneapolis, Minnesota, 55404, United States
Perinatal Associates of New Mexico
Rio Rancho, New Mexico, 87124, United States
NYU Langone Health
New York, New York, 10016, United States
Mount Sinai
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
UH Rainbow Babies / Children's Hospital
Cleveland, Ohio, 44106, United States
Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, 44195, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Utah Health
Salt Lake City, Utah, 84102, United States
University of Vermont Children's Hospital
Burlington, Vermont, 05401, United States
Eastern Virginia Medical School (EVMS)
Norfolk, Virginia, 23507, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Stollery Children's Hospital
Edmonton, Alberta, AB T6G 2B7, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jill Buyon, MD
NYU Langone Health
- PRINCIPAL INVESTIGATOR
Bettina Cuneo, MD
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2020
First Posted
July 16, 2020
Study Start
August 1, 2020
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
June 30, 2029
Last Updated
April 9, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposes to use the data will have access to the data upon reasonable request and when a stated purpose and approval by a committee is provided. Requests should be directed to Jill.Buyon@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.