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First-trimester exposure to amoxycillin/clavulanic acid: a prospective, controlled study
Matitiahu Berkovitch1, Orna Diav-Citrin, Revital Greenberg
1Clinical Pharmacology and Toxicology unit, Drug Consultation Centre, Assaf Harofeh Medical Centre, Zerifin, Israel. mberkovitch@asaf.health.gov.il
British Journal of Clinical Pharmacology
|August 26, 2004
Summary
Exposure to amoxycillin/clavulanic acid during pregnancy is unlikely to increase malformation risks. This study found no significant difference in major malformations between infants exposed to amoxycillin/clavulanic acid and those exposed to amoxycillin alone.
Area of Science:
- Obstetrics and Gynecology
- Pharmacology
- Teratology
Background:
- Limited data exists on amoxycillin/clavulanic acid use in pregnancy.
- Previous studies have small sample sizes, necessitating further investigation.
Purpose of the Study:
- To prospectively assess the safety of intrauterine exposure to amoxycillin/clavulanic acid.
- To evaluate the risk of malformations following first-trimester exposure.
Main Methods:
- A cohort of 191 pregnant women exposed to amoxycillin/clavulanic acid in the first trimester was recruited.
- Exposed women were matched with 191 controls exposed to amoxycillin only based on age, smoking, and alcohol consumption.
Main Results:
- No significant differences were observed in maternal age, birth weight, gestational age, live birth rates, or abortion rates between groups.
- The rate of major malformations in the amoxycillin/clavulanic acid group (1.9%) was not significantly different from the control group (3%).
Conclusions:
- First-trimester exposure to amoxycillin/clavulanic acid does not appear to be associated with an increased risk of major malformations.
- The observed malformation rates are comparable to the general population baseline risk.