Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
completion around
Principal Investigator
by Gary Satou, MD (ucla)Anita Mood-Grady, MD (ucsf)
Headshot of Gary Satou
Gary Satou
Headshot of Anita Mood-Grady
Anita Mood-Grady

Description

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.

Details

Keywords

AVB - Atrioventricular Block, Fetal AVB, Atrioventricular Block, Dexamethasone, IVIG

Eligibility

Locations

  • University of California - Los Angeles (UCLA) accepting new patients
    Los Angeles California 90095 United States
  • University of California-San Francisco accepting new patients
    San Francisco California 94143 United States
  • Stanford University accepting new patients
    Palo Alto California 94305 United States

Lead Scientists at University of California Health

  • Gary Satou, MD (ucla)
    HS Clinical Professor, Pediatrics, Medicine. Authored (or co-authored) 75 research publications
  • Anita Mood-Grady, MD (ucsf)
    Dr. Anita Moon-Grady is the director of the UCSF Fetal Cardiovascular Program. With training in both pediatric cardiology and neonatal/perinatal medicine, she specializes in pediatric and fetal echocardiography (imaging the heart with ultrasound) and intraoperative assessment during congenital cardiac surgery and fetal surgery.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NYU Langone Health
ID
NCT04474223
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1300 study participants
Last Updated