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Related Experiment Videos

Cisapride use during human pregnancy: a prospective, controlled multicenter study

B Bailey1, A Addis, A Lee

  • 1Department of Pediatrics, The Hospital for Sick Children and the University of Toronto, Ontario, Canada.

Digestive Diseases and Sciences
|October 23, 1997
PubMed
Summary

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This study found no increased risk of birth defects or pregnancy loss in women using cisapride during pregnancy. Cisapride use in pregnancy did not lead to lower birth weights or other adverse outcomes.

Area of Science:

  • Obstetrics and Gynecology
  • Pharmacology
  • Teratology

Background:

  • The safety of medications during pregnancy is a critical concern for both patients and healthcare providers.
  • Cisapride, a gastroprokinetic agent, has been used to treat various gastrointestinal disorders.

Purpose of the Study:

  • To investigate the potential association between cisapride exposure during pregnancy and adverse fetal outcomes.
  • Specifically, to assess risks for malformations, spontaneous abortions, and decreased birthweight.

Main Methods:

  • A prospective, multicenter study design was employed.
  • Pregnant women exposed to cisapride were identified and compared to carefully matched control groups (non-teratogen exposed and disease-paired controls).
  • Data collected included maternal history, birthweight, gestational age, and rates of various pregnancy and birth outcomes.

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Main Results:

  • 129 pregnant women were exposed to cisapride, with 88 exposed during the critical period of fetal organogenesis.
  • No significant differences were observed in maternal history, birthweight, gestational age, or rates of livebirths, abortions (spontaneous or therapeutic), fetal distress, or malformations between the cisapride-exposed group and controls.
  • Key pregnancy and neonatal outcomes were comparable across all study groups.

Conclusions:

  • Exposure to cisapride during pregnancy does not appear to be associated with a major increased risk of malformations.
  • The study suggests no significant link between cisapride use in pregnancy and spontaneous abortions or decreased birthweight.
  • Current evidence indicates a favorable safety profile for cisapride regarding major adverse pregnancy and fetal outcomes.