Pregnant women with previous child with cardiac neonatal lupus Anti-SS-A antibody, neonatal lupus, congenital heart block
Conditions
Interventions
Drug: Hydroxychloroquine
Those who meet eligibility criteria will receive 400mg/d of HCQ (two 200mg pills) Mothers already on HCQ will remain on 400mg/d, or escalate to 400mg/d if taking less
than
Hydroxychloroquine
Sponsors
Yokogawa Naoto
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Mothers must have anti-SSA/Ro Ab documented. 2. Mothers must have a previous child with cardiac neonatal lupus (cNL) , defined herein as: during the fetal period or at delivery, the presence of heart block (2nd or 3rd degree) documented by electrocardiogram (EKG), echocardiogram, pacemaker, or statement in the medical record, and/or; presence of cardiac injury, which specifically includes autopsy evidence of a mononuclear infiltrate in the endocardium, myocardium, and pericardium and/or endocardial fibroelastosis (EFE) on echocardiogram 3. Mothers with normal Intrauterine pregancy of =18 5. Mothers must provide an informed consent (assent if age <18) based on the free will to the explanation using documents
Exclusion criteria
Exclusion criteria: 1. 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) 2. Mother is taking fluorinated steroids (dexamethasone, betamethasone, intravenously or orally) 3. Mother is taking more than 20mg/d of prednisolone 4. Contraindication of HCQ: history of hypersensitivity to HCQ, retinopathy (except SLE retinopathy)or maculopathy 5. Mothers with a serious condition of either cardiovascular disease, pulmonary disease, liver disease, renal disease, gastrointestinal disease, hematologic disease, or thyroid disease in reference to Grade 3 adverse events of Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 6. Mothers diagnosed with bipolar disorder, depression with psychotic features, schizophrenia, obsessive-compulsive disorder 7. Mothers known to have difficulty in seeing physicians during the clinical trial 8. Mothers who refuse to observe her child after birth 9. Mothers who physicians in charge judge inappropriate as a subject for this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| congenital heart block (type II or III) during fetal period or at birth | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) congenital heart block I, II, or III, respectively, 2) cNL (See inclusion criteria) 3) Any sign of myocardial injury, without change in cardiac rate or rhythm, a) shortening fraction 0.33; c) hydropic changes; d) moderate/severe tricuspid regurgitation. 4) Echocardiographic densities consistent with EFE (excluding mild EFE without cardiac injury) 5) Fetal death not related to cardiac dysfunction 6) Prematurity (gestational age <37 weeks at birth) 7) Birth weight <10% in the context of gestational age 8) Abnormal fluid collection 9) Safety (until delivery except eye examination) 10) Neonatal lupus rash | — |
Contacts
Public ContactNaoto Yokogawa
Department of Rheumatic Diseases, Tokyo Metropolitan Tama Medical Center
Outcome results
None listed