Table 3.

The risk for major malformations following first trimester exposure to NSAID stratified by defined daily dose (DDD)*.

Total No. DDDMajor Malformations, No./Total (%)Adjusted OR** (95% CI)
None6164/105,537 (5.8)1 (reference)
1–5113/1623 (7)0.91 (0.63–1.31)
6–1082/1370 (6)1.11 (0.73–1.67)
≥ 1131/496 (6.3)0.93 (0.6–1.43)
  • * Defined daily dose: the assumed average maintenance dose per day for a drug used for its main indication in adults.

  • ** Adjusted for maternal age, parity, population group, gestational diabetes mellitus, maternal inflammatory disease, and year of birth or pregnancy termination. NSAID: non-steroidal antiinflammatory drug.