Journal
REPRODUCTIVE TOXICOLOGY
Volume 30, Issue 3, Pages 401-404Publisher
PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/j.reprotox.2010.04.010
Keywords
Pregnancy; Diclofenac; Teratogenicity; Fetal outcome; Birth defects
Categories
Ask authors/readers for more resources
Objective: To assess the safety of diclofenac during pregnancy. Methods: A prospective observational cohort study, evaluating follow-up data of women who contacted Teratology Information Services to get counseling. The exposed group included 145 pregnant women who were exposed to diclofenac between the 5th and the 14th gestational week. A contemporary control group (501 women) was randomly selected from among patients who contacted Teratology Information Services with regard to exposures to agents known not to be teratogenic during a similar period of pregnancy. Results: Major birth malformations were not more common in the study group than in the control group (p = 0.07). Conclusion: Our study suggests that the use of diclofenac is relatively safe during the first trimester of pregnancy and the studied sample size makes it possible to exclude a risk of congenital malformation higher than 3.3, with a power of 80%. (C) 2010 Elsevier Inc. All rights reserved.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available