The factors associated with the development of cardiac manifestations of neonatal lupus (cardiac-NL) in fetuses with positive anti-SSA/Ro and/or SSB/La (anti-SSA/SSB) antibodies are unclear. This study aimed to investigate the predictive factors of fetal cardiac-NL in anti-SSA/SSB antibody-positive pregnant women.

A total of 669 pregnant women with positive anti-SSA/SSB antibodies were retrospectively included. We determined whether the fetus had cardiac-NL and collected relevant clinical data. Univariate and multivariate analyses were performed to analyze the correlation between fetal cardiac-NL and clinical characteristics.

Among 669 pregnant women with positive anti-SSA/SSB antibody tests, 26 cases of fetal cardiac-NL occurred. Univariate analysis showed that fetal cardiac-NL was positively correlated with the assisted reproduction (odds ratio [OR]: 2.824; p = 0.045), strong positive anti-SSA/SSB antibody (OR: 6.437; p < 0.001), and clinical diagnosis of connective tissue disease (CTD; OR: 4.701; p = 0.037); it was negatively correlated with the use of hydroxychloroquine (HCQ; OR: 0.187; p < 0.001) and aspirin (OR: 0.369; p = 0.048). Multivariate analysis showed that the assisted reproduction (OR: 4.110; p = 0.029), strong positive anti-SSA/SSB antibody (OR: 8.691; p < 0.001), and clinical diagnosis of CTD (OR: 8.614; p = 0.010) were risk factors for fetal cardiac-NL; while HCQ (OR: 0.091; p < 0.001) and aspirin (OR: 0.318; p = 0.035) were protective factors for fetal cardiac-NL.

This study determined that assisted reproduction, strong positive anti-SSA/SSB antibody, and clinical diagnosis of CTD are independent risk factors for fetal cardiac-NL. The use of HCQ and aspirin are independent protective factor for fetal cardiac-NL.

Anti-SSA/SSB antibodies can lead to fetal cardiac-NL.

Assisted reproduction, strong positive anti-SSA/SSB antibodies, and CTD are risk factors.

HCQ and aspirin use may lower the risk of fetal cardiac-NL.

The protocol was approved by the Institutional Ethics Committee of Beijing Anzhen Hospital of Capital Medical University (approval number: 2022060X).

Written informed consent was obtained from the prospective parents.

All the authors have revised and contributed to drafting the manuscript. The authors have accepted responsibility for the entire content of this manuscript and approved its submission.

*Contributed equally to the study.

Received: 12 June 2025

Accepted: 16 July 2025

Accepted Manuscript online:
17 July 2025

Article published online:
30 July 2025

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