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.
- Atrioventricular Block
- Fetal Atrioventricular Block
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: 1 year post-birth
Trial Safety
Phase-Based Safety
Side Effects for
Awards & Highlights
Trial Design
1 Treatment Group
Mothers with Fetuses Who Have 2° AVB or AV interval > 170ms
1 of 1
Experimental Treatment
1300 Total Participants · 1 Treatment Group
Primary Treatment: IVIG · No Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · Female Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor