Preventive Approach to Congenital Heart Block with Hydroxychloroquine: an investigator-initiated clinical trial using telemedicine in Japa
Phase 3
Recruiting
- Conditions
- Pregnant women with previous child with cardiac neonatal lupus
- Registration Number
- JPRN-UMIN000028979
- Lead Sponsor
- Tokyo Metropolitan Tama Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
1. Mother does not have Ab to SSA/Ro or SSB/La. 2. Identification of any of the following structural lesions considered causal for CHB, i.e., L-transposition of the great arteries, polysplenia, atrioventricular septal defects, etc) 3. Mother is taking fluorinated steroids (dexamethasone, betamethasone) 4. Contraindication of HCQ: history of hypersensitivity to HCQ, retinopathy (except SLE retinopathy)or maculopathy 5. lack of cooperation of local rheumatologists, obstetricians, and pediatric cardiologists 6. difficulty in visiting hospital or home-visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Advanced heart block (type II or III) [screening fetal echocardiography: biweekly from 18 weeks to 26 weeks]
- Secondary Outcome Measures
Name Time Method