The risk for major malformations following first trimester exposure to NSAID stratified by defined daily dose (DDD)*.
| Total No. DDD | Major Malformations, No./Total (%) | Adjusted OR** (95% CI) |
|---|---|---|
| None | 6164/105,537 (5.8) | 1 (reference) |
| 1–5 | 113/1623 (7) | 0.91 (0.63–1.31) |
| 6–10 | 82/1370 (6) | 1.11 (0.73–1.67) |
| ≥ 11 | 31/496 (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.