Hydroxychloroquine in Pregnancy and Risk of Birth Defects
Author Information
Author(s): Nguyen Ngoc V, Svenungsson Elisabet, Dominicus Annica, Altman Maria, Hellgren Karin, Simard Julia F, Arkema Elizabeth V
Primary Institution: Karolinska Institutet, Stockholm, Sweden
Hypothesis
Does first-trimester exposure to hydroxychloroquine increase the risk of major congenital malformations in infants born to mothers with systemic lupus erythematosus or rheumatoid arthritis?
Conclusion
First-trimester exposure to hydroxychloroquine was not associated with a significantly increased risk of major congenital malformations.
Supporting Evidence
- 1007 births were included in the SLE cohort, with 453 exposed to hydroxychloroquine.
- 2500 births were included in the RA cohort, with 144 exposed to hydroxychloroquine.
- The adjusted risk ratios for SLE and RA cohorts were 1.29 and 1.32, respectively, indicating no significant increase in risk.
Takeaway
Taking hydroxychloroquine during the first three months of pregnancy doesn't seem to harm the baby, so it might be safe for mothers with certain diseases.
Methodology
This study analyzed data from Swedish nationwide registers, including singleton births from 2006 to 2021, comparing infants exposed to hydroxychloroquine during the first trimester to those unexposed.
Potential Biases
Potential misclassification of exposure and outcome due to reliance on prescription data without confirming actual use.
Limitations
The study did not include pregnancies that ended in abortion, which may have led to an underestimation of the risk of major congenital malformations.
Participant Demographics
The study included mothers with systemic lupus erythematosus or rheumatoid arthritis, with a mean age at conception of 31-33 years.
Statistical Information
Confidence Interval
95% CI: 0.65, 2.56 for SLE; 95% CI: 0.56, 3.13 for RA
Digital Object Identifier (DOI)
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