TY - JOUR
T1 - Cisapride use during human pregnancy
T2 - A prospective, controlled multicenter study
AU - Bailey, Benoit
AU - Addis, Antonio
AU - Lee, Amy
AU - Sanghvi, Kinjal
AU - Mastroiacovo, Pierpaolo
AU - Mazzone, Teresa
AU - Bonati, Maurizo
AU - Paolini, Cinzia
AU - Garbis, Hanneke
AU - Val, Thierry
AU - De Souza, Carolina F.M.
AU - Matsui, Doren
AU - Schechtman, Amy Stein
AU - Conover, Beth
AU - Lau, Melissa
AU - Koren, Gideon
N1 - Funding Information:
Supported by Jansse n Inc., Canada. Benoit Bailey was supported by a Canadian Society for Clinical Pharmacology Fellowship.
PY - 1997
Y1 - 1997
N2 - The objective of this prospective multicenter study was to determine whether cisapride is associated with increased risk of malformations, spontaneous abortions, or decreased birthweight when used during pregnancy. Cases were paired for age, smoking, and alcohol consumption with controls exposed to nonteratogens, as well as with disease-paired controls. One hundred and twenty-nine pregnant women were exposed to cisapride during pregnancy, including 88 during the period of fetal organogenesis. There were no differences in maternal history, birthweight, gestational age at delivery, and rates of livebirths, spontaneous or therapeutic abortions, fetal distress, and major or minor malformations among groups. It is concluded that exposure to cisapride during pregnancy is not associated with a major increased risk of malformations or spontaneous abortions or with decreased birthweight.
AB - The objective of this prospective multicenter study was to determine whether cisapride is associated with increased risk of malformations, spontaneous abortions, or decreased birthweight when used during pregnancy. Cases were paired for age, smoking, and alcohol consumption with controls exposed to nonteratogens, as well as with disease-paired controls. One hundred and twenty-nine pregnant women were exposed to cisapride during pregnancy, including 88 during the period of fetal organogenesis. There were no differences in maternal history, birthweight, gestational age at delivery, and rates of livebirths, spontaneous or therapeutic abortions, fetal distress, and major or minor malformations among groups. It is concluded that exposure to cisapride during pregnancy is not associated with a major increased risk of malformations or spontaneous abortions or with decreased birthweight.
KW - Cisapride
KW - Drug-induced abnormality
KW - Human
KW - Pregnancy
UR - http://www.scopus.com/inward/record.url?scp=9844224475&partnerID=8YFLogxK
U2 - 10.1023/A:1018898707449
DO - 10.1023/A:1018898707449
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C2 - 9331146
AN - SCOPUS:9844224475
SN - 0163-2116
VL - 42
SP - 1848
EP - 1852
JO - Digestive Diseases and Sciences
JF - Digestive Diseases and Sciences
IS - 9
ER -