title: First trimester diclofenac exposure and pregnancy outcome.
abstract: 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).
  
  
  CONCLUSIONS
  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%.
authors.affiliation: Servizio di Informazione Teratologica, Genetica Clinica, Department of Pediatrics, University of Padova, Padova, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Cassina
authors.forename: Marco
authors.initials: M
authors.lastname: De Santis
authors.forename: Elena
authors.initials: E
authors.lastname: Cesari
authors.forename: Marion
authors.initials: M
authors.lastname: van Eijkeren
authors.forename: Matitiahu
authors.initials: M
authors.lastname: Berkovitch
authors.forename: Giorgio
authors.initials: G
authors.lastname: Eleftheriou
authors.forename: Francesco
authors.initials: F
authors.lastname: Raffagnato
authors.forename: Elena
authors.initials: E
authors.lastname: Di Gianantonio
authors.forename: Maurizio
authors.initials: M
authors.lastname: Clementi
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology / Q000209:etiology*; D000022:Abortion, Spontaneous / Q000139:chemically induced* / Q000453:epidemiology; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects*; D015331:Cohort Studies; D004008:Diclofenac / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D011247:Pregnancy; D011256:Pregnancy Outcome; D011261:Pregnancy Trimester, First; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D004008:Diclofenac