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  • Title: Antenatal exposure to doxylamine succinate and dicyclomine hydrochloride (Benedectin) in relation to congenital malformations, perinatal mortality rate, birth weight, and intelligence quotient score.
    Author: Shapiro S, Heinonen OP, Siskind V, Kaufman DW, Monson RR, Slone D.
    Journal: Am J Obstet Gynecol; 1977 Jul 01; 128(5):480-5. PubMed ID: 879205.
    Abstract:
    In a prospective cohort study of 20, 282 gravidas and their offspring, congenital malformation rates were similar in the children of over 1,000 women exposed and those not exposed to two components of Bendectin (doxylamine succinate and dicyclomine hydrochloride) during the first four lunar months of pregnancy. In a cohort reduced to 41,337 mother-child pairs for technical reasons, mean birth weight and perinatal mortality rates were similar according to exposure or nonexposure to either drug, as were intelligence quotient scores measured at four years of age in 28,358 of the children. Control of potential confounding factors with a variety of multivariate techniques did not materially alter these findings. The effects of doxylamine succinate (DAS) and dicylomin hydrochloride (DHC), each of which is contained in the drug Bendectin, administration during pregnancy on offspring was investigated in a prospective cohort study of 50,282 women and their offspring. The overall malformaton rate was similar among 509 heavily exposed infants, 660 moderately exposed children, and 49,113 who were not exposed.Treatment also did not appear to affect mean birth weight, the rate of perinatal mortality, and intelligence quotient scores determined at 4-years of age.
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