Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT00007358
Eligibility Criteria:
Inclusion Criteria for Prospective Part of Trial:
* Mother must have anti-Ro and/or anti-La antibody
* Fetal bradyarrhythmia (slow, abnormal heart rhythm)
Exclusion Criteria for Prospective Part of Trial:
* Fetal heart abnormalities that may cause newborn CHB and could account for atrioventricular (AV) block
Inclusion Criteria for Observational Part of Trial:
* Mother must have anti-Ro and/or anti-La antibody
* Fetus must have documented normal heartbeat prior to the 16th week of pregnancy
* Fetus must have a structurally normal heart
* Mother must be enrolled during the 16th, 17th, or 18th week of pregnancy
Exclusion Criteria for Observational Part of Trial:
* Mother is taking more than 10 mg of prednisone per day
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
50 Years
Study:
NCT00007358
Study Brief:
Protocol Section:
NCT00007358