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

  • Makhoul, Majd (PI)

Grants and Contracts Details

Description

The University of Kentucky Research Foundation, under the direction of Site Lead Dr. Majd Makhoul, proposes to participate as a clinical site in the STOP BLOQ Study (MPIs: Jill P. Buyon, MD and Bettina F. Cuneo, MD) as follows: The Site Lead and other Site study personnel will recruit pregnant anti-Ro positive women and follow the clinical protocol for surveillance and treatment, which includes. a. Sending maternal serum to Dr. Jill Buyon’s laboratory at NYU School of Medicine to quantify anti-Ro antibody levels b. To teach or supervise teaching mothers fetal heart rhythm and ratemonitoring (FHRM) c. Responding to mother’s audiotexts if they question results of FHRM d. Perform and interpret or interpret diagnostic fetal echocardiograms within 6 hours of an abnormal FHRM e. Follow the management and treatment protocol f. Participate for the 5-year duration of the study, commencing September 2019. The University of Kentucky Research Foundation will cede institutional review to the New York University School of Medicine Institutional Review Board, acting as the single centralized IRB (sIRB) and providing a single identical consent form for all participants. Please be reminded that reimbursement of all costs, including salary, will be made on a MILESTONE basis: $500 in direct costs per patient enrolled in STEP 2, plus an additional $1,000 in direct costs for each patient treated in STEP 3.
StatusFinished
Effective start/end date9/1/206/21/22

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