THE SAFETY OF OMEPRAZOLE DURING PREGNANCY - A MULTICENTER PROSPECTIVECONTROLLED-STUDY

OBJECTIVES: Our purpose was to determine whether omeprazole use during pregnancy is associated with an increased risk of malformations, spon taneous abortions, decreased birth weight, or perinatal complications. STUDY DESIGN: In a multicenter, prospective controlled study, pregnan t women exposed to omeprazole during gestation were matched with contr ols exposed to nonteratogens and with disease-paired controls who used histamine blockers for similar indications. The primary end point was the incidence of major malformations. RESULTS: One hundred thirteen p regnant women were exposed to omeprazole during pregnancy. Rates of ma jor malformations in the omeprazole group (4%) did not differ from con trols exposed to nonteratogens (2%) (P=.68, relative risk=1.94, 95% co nfidence interval 0.36 to 10.36) and disease-paired controls (2.8%). B irth weight, gestational age at delivery, preterm deliveries, and neon atal complications were comparable among the three groups. CONCLUSIONS : No association was found between exposure to omeprazole during the p eriod of organogenesis and increased risk for major malformations. Exp osure throughout pregnancy is not associated with increased risk of sp ontaneous abortions, decreased birth weight, or perinatal complication s.