Cisapride use during human pregnancy: a prospective, controlled multicenter study.
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.
Bailey
B
B
Department of Pediatrics, The Hospital for Sick Children and the University of Toronto, Ontario, Canada.
Addis
A
A
Lee
A
A
Sanghvi
K
K
Mastroiacovo
P
P
Mazzone
T
T
Bonati
M
M
Paolini
C
C
Garbis
H
H
Val
T
T
De Souza
C F
CF
Matsui
D
D
Schechtman
A S
AS
Conover
B
B
Lau
M
M
Koren
G
G
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology* / Q000209:etiology; D000022:Abortion, Spontaneous / Q000139:chemically induced*; D000328:Adult; D001724:Birth Weight / Q000187:drug effects*; D016022:Case-Control Studies; D020117:Cisapride; D015331:Cohort Studies; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D007231:Infant, Newborn; D010880:Piperidines / Q000009:adverse effects* / Q000627:therapeutic use; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D011446:Prospective Studies; D012307:Risk Factors
D005765:Gastrointestinal Agents; D010880:Piperidines; D020117:Cisapride