Trial reportArthritis and rheumatism2010
Evaluation of fetuses in a study of intravenous immunoglobulin as preventive therapy for congenital heart block: Results of a multicenter, prospective, open-label clinical trial.
Trial report in Arthritis and rheumatism, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00074373 (The Research Registry for Neonatal Lupus), which is not on this map. Cited by 74 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Research Registry for Neonatal Lupus
Who cites it
74 citing papers in PubMed, 3 syntheses or guidelines pooled it, 237 citations in OpenAlex.
- Guidelines on the Use of Therapeutic Apheresis in Clinical Practice-Evidence-Based Approach From the Writing Committee of the American Society for Apheresis: The Tenth Special Issue.Journal of clinical apheresis · 2026Guideline
- British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids.Rheumatology (Oxford, England) · 2023Guideline
- Clinical practice guideline on pregnancy and renal disease.BMC nephrology · 2019Guideline
- Prospective Evaluation of High Titer Autoantibodies and Fetal Home Monitoring in the Detection of Atrioventricular Block Among Anti-SSA/Ro Pregnancies.Arthritis & rheumatology (Hoboken, N.J.) · 2024Trial
- Hydroxychloroquine to Prevent Recurrent Congenital Heart Block in Fetuses of Anti-SSA/Ro-Positive Mothers.Journal of the American College of Cardiology · 2020Trial
- Association of the idiotype:antiidiotype antibody ratio with the efficacy of intravenous immunoglobulin treatment for the prevention of recurrent autoimmune-associated congenital heart block.Arthritis and rheumatism · 2011Trial
- Echogenicities in the Fetal Heart: Echocardiographic Evaluation, Differential Diagnosis and Clinical Outcomes.Pediatric cardiology · 2026Review
- Discordant Manifestation of Congenital Heart Block in a Twin Pregnancy: A Case Report.Diagnostics (Basel, Switzerland) · 2026Article
- Blocking the neonatal Fc receptor as a novel approach to prevent cardiac neonatal lupus: a proof-of-concept study.Annals of the rheumatic diseases · 2026Article
- Complete Heart Block in the Fetus: An Antenatal Complication of Sjögren's Syndrome.Life (Basel, Switzerland) · 2025Article
- Case Report: Siblings with neonatal lupus erythematosus.Frontiers in pediatrics · 2025Article
- Case Report: A multidisciplinary, protocol-driven pathway from recurrent pregnancy loss to live birth in an anti-Ro/SSA-positive primary Sjögren's syndrome pregnancy with literature review.Frontiers in immunology · 2025Review
- Congenital Complete Heart Block-To Stimulate (When?) or Not to Stimulate?Healthcare (Basel, Switzerland) · 2024Article
- Molecular Mechanisms of Fetal and Neonatal Lupus: A Narrative Review of an Autoimmune Disease Transferal across the Placenta.International journal of molecular sciences · 2024Review
- Monitoring of Women with Anti-Ro/SSA and Anti-La/SSB Antibodies in Germany-Status Quo and Intensified Monitoring Concepts.Journal of clinical medicine · 2024Article
- Autoimmune congenital heart block: a case report and review of the literature related to pathogenesis and pregnancy management.Arthritis research & therapy · 2024Review
- Complete Congenital Heart Block in the Offspring of an Asymptomatic Woman with Isolated High Titer Anti-Ro Antibody.Acta medica Philippina · 2024Article
- Dual challenge inside the womb: a case report of concomitant fetal atrio-ventricular block associated with maternal anti-SSA antibodies and fetal tachyarrhythmia diagnosed as Wolff-Parkinson-White syndrome after birth.Frontiers in immunology · 2024Article
- Review
- Autoimmune Congenital Complete Heart Block: How Late Can It Occur?AJP reports · 2023Review
14 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
23 authors at 13 institutions in 1 country.
Funding
Abstract
objectiveThe recurrence rate of anti-SSA/Ro-associated congenital heart block (CHB) is 17%. Sustained reversal of third-degree block has never been achieved. Based on potential reduction of maternal autoantibody titers as well as fetal inflammatory responses, intravenous immunoglobulin (IVIG) was evaluated as preventive therapy for CHB.
methodsA multicenter, prospective, open-label study based on Simon's 2-stage optimal design was initiated. Enrollment criteria included the presence of anti-SSA/Ro antibodies in the mother, birth of a previous child with CHB/neonatal lupus rash, current treatment with < or = 20 mg/day of prednisone, and <12 weeks pregnant. IVIG (400 mg/kg) was given every 3 weeks from week 12 to week 24 of gestation. The primary outcome was the development of second-degree or third-degree CHB.
resultsTwenty mothers completed the IVIG protocol before the predetermined stopping rule of 3 cases of advanced CHB in the study was reached. CHB was detected at 19, 20, and 25 weeks; none of the cases occurred following the finding of an abnormal PR interval on fetal Doppler monitoring. One of these mothers had 2 previous children with CHB. One child without CHB developed a transient rash consistent with neonatal lupus. Sixteen children had no manifestations of neonatal lupus at birth. No significant changes in maternal titers of antibody to SSA/Ro, SSB/La, or Ro 52 kd were detected over the course of therapy or at delivery. There were no safety issues.
conclusionThis study establishes the safety of IVIG and the feasibility of recruiting pregnant women who have previously had a child with CHB. However, IVIG at low doses consistent with replacement does not prevent the recurrence of CHB or reduce maternal antibody titers.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.