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New treatment option for AVB - Atrioventricular Block
Official title Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly (STOP BLOQ)
ClinicalTrials.gov ID: NCT04474223
What this study is testing
What is Dexamethasone?
Dexamethasone is an investigational medicine, given as an once-weekly, being studied as a potential treatment for avb - atrioventricular block.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Be \<18 weeks pregnant at the time of enrollment
- Titer of anti-Ro 52 or 60 antibodies ≥1,000 EU
- Any positive titer of anti-Ro if a history of a previously affected child
You likely can't join if
- Multi-fetal pregnancy
- Known allergic reactions to components of IVIG, or dexamethasone or maternal IgA deficiency
- Fetal conduction system disease already present in the current pregnancy
- Any women who in the opinion of the investigator cannot understand the consent form or be able to perform thrice daily home monitoring or recognize...
- Women prisoners
- Treatment with \>20 mg/prednisone q day or with any dose of fluorinated steroids at enrollment
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Be \<18 weeks pregnant at the time of enrollment
- Titer of anti-Ro 52 or 60 antibodies ≥1,000 EU
- Any positive titer of anti-Ro if a history of a previously affected child
- Ability to take oral medication and be willing to adhere to the dexamethasone and IVIG protocols.
- Ability to perform Doppler fetal heart rate and rhythm monitoring in the ambulatory setting,
- Ability to send an audiotext message by cell phone therefore the participant will be informed that they need a phone with texting capabilities. Located within 6 hours drive of the participating pediatric cardiology site
- Be ≥18 years of age
- Multi-fetal pregnancy
- Known allergic reactions to components of IVIG, or dexamethasone or maternal IgA deficiency
- Fetal conduction system disease already present in the current pregnancy
- Any women who in the opinion of the investigator cannot understand the consent form or be able to perform thrice daily home monitoring or recognize an abnormal fetal heart rate or rhythm
- Women prisoners
- Treatment with \>20 mg/prednisone q day or with any dose of fluorinated steroids at enrollment
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Lexington, Kentucky, United States
- Louisville, Kentucky, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- Rio Rancho, New Mexico, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Burlington, Vermont, United States
- Norfolk, Virginia, United States
- Seattle, Washington, United States
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Los Angeles, California, United States; Palo Alto, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.