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

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,300

Participants

Timeline

Start Date

August 1, 2020

Primary Completion Date

December 31, 2028

Study Completion Date

June 30, 2029

Conditions
AVB - Atrioventricular BlockFetal AVB
Interventions
DRUG

Dexamethasone

"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"

DRUG

IVIG

"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."

Trial Locations (24)

10016

RECRUITING

NYU Langone Health, New York

10029

RECRUITING

Mount Sinai, New York

10032

RECRUITING

Columbia University Medical Center, New York

20010

RECRUITING

Children's National Medical Center/George Washington University, Washington D.C.

23507

RECRUITING

Eastern Virginia Medical School (EVMS), Norfolk

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

40202

NOT_YET_RECRUITING

University of Louisville / Norton Children's Hospital, Louisville

40536

RECRUITING

University of Kentucky / Kentucky Children's Hospital, Lexington

44106

RECRUITING

UH Rainbow Babies / Children's Hospital, Cleveland

44195

RECRUITING

Cleveland Clinic Lerner College of Medicine, Cleveland

48109

RECRUITING

University of Michigan / C. S. Mott Children's Hospital, Ann Arbor

55404

RECRUITING

Children's Hospital of Minnesota, Minneapolis

77030

RECRUITING

Baylor College of Medicine, Houston

80204

RECRUITING

University of Colorado, Denver (UCD), Aurora

84102

RECRUITING

University of Utah Health, Salt Lake City

85016

RECRUITING

Phoenix Children's Hospital/Dignity Health, Phoenix

87124

RECRUITING

Perinatal Associates of New Mexico, Rio Rancho

90095

RECRUITING

University of California - Los Angeles (UCLA), Los Angeles

94143

RECRUITING

University of California-San Francisco, San Francisco

94305

RECRUITING

Stanford University, Palo Alto

98105

NOT_YET_RECRUITING

Seattle Children's Hospital, Seattle

06510

RECRUITING

Yale University School of Medicine, New Haven

05401

RECRUITING

University of Vermont Children's Hospital, Burlington

AB T6G 2B7

NOT_YET_RECRUITING

Stollery Children's Hospital, Edmonton

All Listed Sponsors
lead

NYU Langone Health

OTHER

NCT04474223 - Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly (STOP BLOQ) | Biotech Hunter | Biotech Hunter