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Corticosteroid

Dexamethasone + IVIG for Fetal AV Block

Phase 3
Recruiting
Led By Bettina Cuneo, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Located within 6 hours drive of the participating pediatric cardiology site
Be <18 weeks pregnant at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post-birth
Awards & highlights

Study Summary

This trial is investigating a way to improve the treatment of a heart condition called fetal complete atrioventricular block (3° AVB). This heart condition is almost always caused by a mother's antibodies, and it is fatal in 1/5 of cases. Current treatment for 3° AVB is not effective, so this trial is testing a new way to treat it.

Who is the study for?
This trial is for pregnant women over 18 with high levels of anti-Ro antibodies, which are linked to fetal heart block. They must be able to monitor the baby's heart rate at home, send audio texts, live within a 6-hour drive of the cardiology site, and take oral medication. It excludes those with multi-fetal pregnancies or known allergies to the study drugs.Check my eligibility
What is being tested?
The STOP BLOQ trial tests if early detection and treatment can prevent severe fetal atrioventricular block in babies whose mothers have specific autoantibodies. It involves risk assessment, home monitoring by mothers, and rapid treatment with Dexamethasone or IVIG upon detecting abnormalities.See study design
What are the potential side effects?
Dexamethasone may cause increased blood sugar levels, mood changes, stomach ulcers or increased appetite. IVIG might lead to mild flu-like symptoms such as fever or muscle aches; more rarely it could cause allergic reactions or impact kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I live within a 6-hour drive of the pediatric cardiology site.
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I am less than 18 weeks pregnant.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-birth
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-birth for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of 2° AVB subjects with NR (1:1 AV conduction) at birth
Secondary outcome measures
Incidences of isolated extra-nodal cardiac disease
Percentage of 2° AVB subjects who maintain NR at age 1 year.
Percentage of AV interval > 170 msec subjects with NR at birth

Side effects data

From 2020 Phase 3 trial • 105 Patients • NCT03065244
45%
Continued Fever after treatment completion and crossover to other study treatment
20%
Hemolytic Anemia
10%
Rash
8%
GI Symptoms
8%
Arthritis/pain and swelling in extremities
6%
Epistaxis
6%
Fever after discharge not attributed to KD
6%
Fever following crossover treatment
4%
Headache
4%
URI
100%
80%
60%
40%
20%
0%
Study treatment Arm
IVIG
Infliximab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Mothers with Fetuses Who Have 2° AVB or AV interval > 170msExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
IVIG
2016
Completed Phase 4
~2970

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
838,426 Total Patients Enrolled
Bettina Cuneo, MDPrincipal InvestigatorUniversity of Colorado, Denver
Jill Buyon, MDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
307 Total Patients Enrolled

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04474223 — Phase 3
Atrioventricular Block Research Study Groups: Mothers with Fetuses Who Have 2° AVB or AV interval > 170ms
Atrioventricular Block Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT04474223 — Phase 3
Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04474223 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How is IVIG typically used to help patients?

"IVIG is the standard form of treatment for ophthalmia, sympathetic. Additionally, this medication can be used to manage branch retinal vein occlusion and macular edema."

Answered by AI

What is the previous research on IVIG that this study expands upon?

"The immunoglobulin therapy commonly known as IVIG was first explored in 2002 by the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. Since then, there have been 1118 completed studies and 579 active trials, with a significant concentration of research being conducted in Burlington, Vermont."

Answered by AI

Is this study still seeking participants?

"Correct. Based on the information available from clinicaltrials.gov, this study is currently looking for 1300 participants across 37 different locations. The trial was first posted on August 1st 2020 and has since been updated January 11th 2022."

Answered by AI

Could you please tell me the risks associated with IVIG treatments?

"There is prior clinical data supporting IVIG's safety, so it received a score of 3."

Answered by AI

How many places are testing this new treatment?

"Currently, 37 different locations are running this trial. The sites in Burlington, Edmonton and Las Vegas as well as other cities offer this study. If you choose to participate, it may be helpful to pick a location near to reduce travel time and expenses."

Answered by AI

How many research subjects are involved in this project?

"In order to complete this clinical trial, 1,300 individuals that meet the specified inclusion criteria must enroll. These potential participants can be located at University of Vermont Children's Hospital in Burlington or Stollery Children's Hospital in Edmonton."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly (STOP BLOQ)
2020. "Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly (STOP BLOQ)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04474223.
~325 spots leftby Aug 2025
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