Cisapride use during pregnancy: A prospective observational cohort

There are no human data on the safety of cisapride (C) during pregnancy despite its frequent use in childbearing women. The objectives of our study was to determine if C is associated with increased risk of malformations, spontaneous abortions and decreased birth weight. All women counselled by the Motherisk Program on the use of C during pregnancy between January 1988 and June 1996 were followed using a structured questionnaire. Cases were matched for age, smoking and alcohol consumption with known non-teratogen controls (NTC) and with disease matched controls (DMC). A total of 45 pregnant women were exposed to C during pregnancy. There was no difference in maternal history, weight gain during pregnancy; rates of livebirths, spontaneous abortion, fetal distress and IUGR; or gestational age at delivery and birth weight between groups. The rate of prematurity was higher in the C exposed and in the DMC than in the NTC, 14, 15 and 2.5%, (p=0.03); but it was not statistically different than in the general population (5.8%). The rate of major (0 - 0 - 3%) and minor malformations (8 - 8 - 10%) were not different among groups (C - DMC - NTC). This is the first human report suggesting that C is not associated with a major increase risk of malformations, spontaneous abortions or decreased in birth weight.