OBJECTIVES

: To investigate the association between early pregnancy methylprednisolone use and risk of cardiac defects in a national level dataset.

METHODS

: Maternal and child medical claims data were obtained from Truven Health Analytics for all live births from 2000 and 2014. Logistic regression was used to measure the association between early pregnancy exposure to methylprednisolone and risk of structural defects overall, and cardiac and orofacial cleft birth defects specifically.

RESULTS

: Our dataset contained 1,149,145 live births from 1,004,175 mothers. Of these, 22,777 infants were exposed to methylprednisolone in-utero during the first trimester, and 61,830 infants were diagnosed with structural birth defects (32,100 with cardiac birth defects and 1,590 with orofacial cleft defects, specifically). No covariates met the definition of confounding and therefore none were added to the logistic model. First trimester exposure to methylprednisolone was associated with a statistically significantly increased risk of structural defects in general (OR: 1.90 95%CI: 1.80-2.00) and cardiac defects (OR: 2.16 95% CI: 2.02-2.30) and orofacial clefts (OR: 1.57 95% CI: 1.23-2.19) in the exposed mother-child pairs compared to those with no antiemetic exposure in the first trimester.

CONCLUSIONS

: Our research provides evidence showing increased risk of structural defects associated with early pregnancy exposure to methylprednisolone.