Original Research A Multicentre Prospective Controlled Study to Determine the Safety of Trazodone and Nefazodone Use During Pregnancy

Objectives: Trazodone and nefazodone are phenylpiperazine antidepressants. Currently, there are no adequate, well-controlled studies on the fetal safety of these drugs. Our pri-mary objective was to determine whether the use of trazodone or nefazodone during preg-nancy is associated with an increased risk for major malformations. Secondary outcomes of interest included rates of spontaneous and therapeutic abortions, rates of premature labour, and birth weight. Methods: Pregnant women from 5 centres who had been exposed to these drugs (n = 147) were enrolled in the study during their first trimester. We compared the women with 2 groups of women who took either other antidepressant drugs (n = 147) or nonteratogenic drugs (n = 147). All the women were followed up after delivery to ascertain pregnancy out-come and the health of the baby Results: We have completed 147 follow-ups. There were 121 (82.4%) live births, 20 (13.6%) spontaneous abortions, and 6 (4%) therapeutic abortions. Of the live births, there were 2 (1.6%) major malformations. In all cases, drug exposure occurred during the first trimester, with 52 (35%) of the women using these drugs throughout pregnancy. The mean gestational age at birth was 38 weeks (SD 4.2), and the mean birth weight was 3306.34 g (SD 655). We found no statistically significant differences among the 3 groups in any of the endpoints of interest that we examined. Of the sample, 58 women were exposed to tra-zodone, and 89 were exposed to nefazodone. Conclusion: Our results suggest that these drugs do not increase the rates of major malfor-mations above the baseline rate of 1 % to 3%. (Can J Psychiatry 2003;48:106–110) Information on funding support and author affiliations appears at the end of the article