The safety of omeprazole during pregnancy: A multicenter prospective controlled study

A. Lalkin, R. Loebstein, A. Addis, F. Ramezani-Namin, P. Mastroiacovo, T. Mazzone, T. Vial, M. Bonati, G. Koren

Research output: Contribution to journalArticle

Abstract

OBJECTIVES: Our purpose was to determine whether omeprazole use during pregnancy is associated with an increased risk of malformations, spontaneous abortions, decreased birth weight, or perinatal complications. STUDY DESIGN: In a multicenter, prospective controlled study, pregnant women exposed to omeprazole during gestation were matched with controls 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 pregnant women were exposed to omeprazole during pregnancy. Rates of major malformations in the omeprazole group (4%) did not differ from controls exposed to nonteratogens (2%) (P = .68, relative risk = 1.94, 95% confidence interval 0:36 to 10.36) and disease-paired controls (2.8%). Birth weight, gestational age at delivery, preterm deliveries, and neonatal complications were comparable among the three groups. CONCLUSIONS: No association was found between exposure to omeprazole during the period of organogenesis and increased risk for major malformations. Exposure throughout pregnancy is not associated with increased risk of spontaneous abortions, decreased birth weight, or perinatal complications.

Original languageEnglish
Pages (from-to)727-730
Number of pages4
JournalAmerican Journal of Obstetrics and Gynecology
Volume179
Issue number3 I
DOIs
Publication statusPublished - 1998

Fingerprint

Omeprazole
Prospective Studies
Safety
Pregnancy
Birth Weight
Spontaneous Abortion
Pregnant Women
Organogenesis
Histamine
Gestational Age
Confidence Intervals
Incidence

Keywords

  • Malformations
  • Omeprazole
  • Pregnancy
  • Spontaneous abortions

ASJC Scopus subject areas

  • Medicine(all)
  • Obstetrics and Gynaecology

Cite this

Lalkin, A., Loebstein, R., Addis, A., Ramezani-Namin, F., Mastroiacovo, P., Mazzone, T., ... Koren, G. (1998). The safety of omeprazole during pregnancy: A multicenter prospective controlled study. American Journal of Obstetrics and Gynecology, 179(3 I), 727-730. https://doi.org/10.1016/S0002-9378(98)70072-9

The safety of omeprazole during pregnancy : A multicenter prospective controlled study. / Lalkin, A.; Loebstein, R.; Addis, A.; Ramezani-Namin, F.; Mastroiacovo, P.; Mazzone, T.; Vial, T.; Bonati, M.; Koren, G.

In: American Journal of Obstetrics and Gynecology, Vol. 179, No. 3 I, 1998, p. 727-730.

Research output: Contribution to journalArticle

Lalkin, A, Loebstein, R, Addis, A, Ramezani-Namin, F, Mastroiacovo, P, Mazzone, T, Vial, T, Bonati, M & Koren, G 1998, 'The safety of omeprazole during pregnancy: A multicenter prospective controlled study', American Journal of Obstetrics and Gynecology, vol. 179, no. 3 I, pp. 727-730. https://doi.org/10.1016/S0002-9378(98)70072-9
Lalkin, A. ; Loebstein, R. ; Addis, A. ; Ramezani-Namin, F. ; Mastroiacovo, P. ; Mazzone, T. ; Vial, T. ; Bonati, M. ; Koren, G. / The safety of omeprazole during pregnancy : A multicenter prospective controlled study. In: American Journal of Obstetrics and Gynecology. 1998 ; Vol. 179, No. 3 I. pp. 727-730.
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