First-trimester exposure to amoxycillin/clavulanic acid: a prospective, controlled study

Authors

  • Matitiahu Berkovitch,

    Corresponding author
    1. Clinical Pharmacology and Toxicology unit, Drug Consultation Centre, Assaf Harofeh Medical Centre, Zerifin, affiliated with the Sackler School of Medicine, Tel-Aviv University
    Search for more papers by this author
  • Orna Diav-Citrin,

    1. The Israeli Teratogen Information Service, Ministry of Health and Hebrew University, Hadassah Medical School, Jerusalem, Israel
    Search for more papers by this author
  • Revital Greenberg,

    1. Clinical Pharmacology and Toxicology unit, Drug Consultation Centre, Assaf Harofeh Medical Centre, Zerifin, affiliated with the Sackler School of Medicine, Tel-Aviv University
    Search for more papers by this author
  • Michal Cohen,

    1. The Israeli Teratogen Information Service, Ministry of Health and Hebrew University, Hadassah Medical School, Jerusalem, Israel
    Search for more papers by this author
  • Mordechai Bulkowstein,

    1. Clinical Pharmacology and Toxicology unit, Drug Consultation Centre, Assaf Harofeh Medical Centre, Zerifin, affiliated with the Sackler School of Medicine, Tel-Aviv University
    Search for more papers by this author
  • Svetlana Shechtman,

    1. The Israeli Teratogen Information Service, Ministry of Health and Hebrew University, Hadassah Medical School, Jerusalem, Israel
    Search for more papers by this author
  • Oxana Bortnik,

    1. Clinical Pharmacology and Toxicology unit, Drug Consultation Centre, Assaf Harofeh Medical Centre, Zerifin, affiliated with the Sackler School of Medicine, Tel-Aviv University
    Search for more papers by this author
  • Judy Arnon,

    1. The Israeli Teratogen Information Service, Ministry of Health and Hebrew University, Hadassah Medical School, Jerusalem, Israel
    Search for more papers by this author
  • Asher Ornoy

    1. The Israeli Teratogen Information Service, Ministry of Health and Hebrew University, Hadassah Medical School, Jerusalem, Israel
    Search for more papers by this author

Professor Matitiahu Berkovitch MD, Clinical Pharmacology and Toxicology Unit, Drug Consultation Centre, Assaf Harofeh Medical Centre, Zerifin, 70300, Israel.
Tel: + 972 8 977 9152
Fax: + 972 8 977 9138
E-mail: mberkovitch@asaf.health.gov.il

Abstract

Aims

The number of published studies on the use of amoxycillin/clavulanic acid during pregnancy is small and so is the number of pregnancies investigated in those studies. In this study we wished to investigate prospectively the safety of intrauterine exposure to amoxycillin/clavulanic acid in a relatively large cohort of women.

Methods

Women treated (n = 191) with amoxycillin/clavulanic acid during the first trimester of pregnancy were recruited from two teratogen information centres in Israel. Exposed women were matched for age, smoking habits and alcohol consumption with 191 controls exposed to amoxycillin only for similar medical indications.

Results

Maternal age, birth weight, gestational age at delivery, rates of live births and abortions were comparable between the two groups. Rates of major malformations in the amoxycillin/clavulanic acid group (3/158, 1.9%) did not differ significantly from controls (5/163, 3%) (= 0.49, relative risk = 0.62, 95% confidence interval 0.15, 2.55), and were within the expected baseline risk for the general population.

Conclusion

These data suggest that exposure to amoxycillin/clavulanic acid during pregnancy is unlikely to be associated with an increased risk of malformations.

Ancillary