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

StatusActive, Not Recruiting
PhasePhase 3
Started2020-08-01
View on ClinicalTrials.gov ↗

Amendment history

2026-08-24
notable
Study Status, Contacts/Locations v11
Enrollment closed, study ongoing
Study sitesdetails revised at 24 of 24 sites
2026-03-31
minor
Study Status v10
Re-verified, no change to tracked fields
2025-04-08
minor
Study Status v9
Primary completion date2026-08-01→2028-12-31
Completion date2026-10-31→2029-06-30
2024-05-17
minor
Study Status v8
Primary completion date2025-08-01→2026-08-01
2023-07-18
minor
Study Status, Contacts/Locations v7
Study sites36→24
Show 6 earlier versions
2023-01-10
minor
Study Status v6
Primary completion date2026-10-31→2025-08-01
2022-11-22
minor
Study Status, Contacts/Locations v5
Primary completion date2025-08-01→2026-10-31
2022-01-11
minor
Study Status v4
Completion date2026-01-01→2026-10-31
2021-08-19
minor
Study Status v3
Re-verified, no change to tracked fields
2020-09-16
minor
Study Status, Contacts/Locations v2
Study sitescontacts updated at 1 of 36 sites
2020-09-09
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 36 of 36 sites
2020-07-14
minor
Original filing
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 Details
NCT Number NCT04474223
Lead Sponsor NYU Langone Health
Conditions AVB - Atrioventricular Block, Fetal AVB
Enrollment 1,300 participants
Start Date 2020-08-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-25