A multicentre prospective controlled study to determine the safety of @entity3346 and XXXX use during pregnancy.

@entity3346 @entity1 @entity5852 @entity3465 @entity9021 @entity600 @entity37546
OBJECTIVES: @entity3346 and @entity9021 are @entity37546 antidepressants. Currently, there are no adequate, well-controlled studies on the fetal safety of these drugs. Our primary objective was to determine whether the use of @entity3346 or @entity9021 during pregnancy is associated with an increased risk for major @entity600 . Secondary outcomes of interest included rates of spontaneous and therapeutic @entity5852 , rates of @entity3465 , and birth weight. METHODS: Pregnant @entity1 from 5 centres who had been exposed to these drugs (n = 147) were enrolled in the study during their first trimester. We compared the @entity1 with 2 groups of @entity1 who took either other antidepressant drugs (n = 147) or nonteratogenic drugs (n = 147). All the @entity1 were followed up after delivery to ascertain pregnancy outcome and the health of the baby. RESULTS: We have completed 147 follow-ups. There were 121 (82.4%) live births, 20 (13.6%) spontaneous @entity5852 , and 6 (4%) therapeutic @entity5852 . Of the live births, there were 2 (1.6%) major @entity600 . In all cases, drug exposure occurred during the first trimester, with 52 (35%) of the @entity1 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 @entity1 were exposed to @entity3346 , and 89 were exposed to @entity9021 . CONCLUSION: Our results suggest that these drugs do not increase the rates of major @entity600 above the baseline rate of 1% to 3%.
