Abstract
Objective
To study the association between maternal drug use in early pregnancy and orofacial cleft in the infant.
Design
Register analysis based on prospectively collected information.
Patients
All delivered women in Sweden July 1, 1995, through December 31, 2001.
Main outcome measure
Presence of orofacial cleft in infant.
Results
Prospective information on maternal drug use during the first trimester, as reported in early pregnancy, was studied in 1142 infants with orofacial clefts, isolated or with other malformations, excluding chromosome anomalies. Any drug use was not associated with clefts (odds ratio [OR] = 0.98, 95% confidence interval [95% CI] = 0.85 to 1.13), with isolated clefts (OR = 0.92) with isolated median cleft palate (OR = 1.03, 95% CI = 0.79 to 1.36) or with isolated cleft lip with or without cleft palate (OR = 0.86, 95% CI = 0.71 to 1.05). Reported use of multivitamins, folic acid, or B12 was not associated with a decrease in orofacial cleft risk (OR = 1.00, 95% CI = 0.63 to 1.52). ORs above 2 were seen for some drugs: sulfasalazine, naproxen, and anticonvulsants, but only a few exposed cases occurred. An association between glucocorticoid use and infant cleft was indicated and seemed to be strongest for median cleft palate.
Conclusion
Maternal drug use seems to play only a small role for the origin of orofacial clefts, at least in Sweden.
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