Table 5 US FDA pregnancy risk categories of drugs exposure in relation to pregnancy outcome
Variables | Outcomes | Crude OR | Pμ | Adjusted ORα | Pμ | |
|---|---|---|---|---|---|---|
(95% CI) | (95% CI) | |||||
Birth outcome | MC/SB | Live birth | ||||
n (%) | n (%) | |||||
Drugs category ‘A’ | 0.1 (0.1 – 0.3) | < 0.001 | 0.1 (0.08 – 0.3) | < 0.001 | ||
Yes | 51 (73.9) | 880 (95.1) | ||||
No | 18 (26.1) | 45 (4.9) | ||||
Drugs category ‘B’ | 0.6 (0.3 – 1.1) | 0.115 | 0.6 (0.3 – 1.1) | 0.111 | ||
Yes | 12 (17.4) | 241 (26.1) | ||||
No | 57 (82.6) | 684 (73.9) | ||||
Drugs category ‘C’ | 1.4 (0.8 – 2.3) | 0.261 | 1.4 (0.8 – 2.4) | 0.257 | ||
Yes | 20 (29.0) | 213 (23.0) | ||||
No | 49 (71.0) | 712 (77.0) | ||||
Drugs category ‘D’ | 1.0 (0.3 – 2.9) | 0.974 | 0.9 (0.3 – 3.2) | 0.939 | ||
Yes | 3 (4.3) | 41 (4.4) | ||||
No | 66 (95.7) | 884 (95.6) | ||||
Birth weight (grams) | < 2500 | ≥ 2500 | ||||
n (%) | n (%) | |||||
Drugs category ‘A’ | 0.5 (0.2 – 1.4) | 0.191 | 0.5 (0.2 – 1.5) | 0.207 | ||
Yes | 40 (90.9) | 840 (95.4) | ||||
No | 4 (9.1) | 41 (4.6) | ||||
Drugs category ‘B’ | 0.5 (0.2 – 1.2) | 0.122 | 0.5 (0.2 – 1.2) | 0.125 | ||
Yes | 7 (15.9) | 234 (26.6) | ||||
No | 37 (84.1) | 647 (73.4) | ||||
Drugs category ‘C’ | 0.7 (0.3 – 1.6) | 0.436 | 0.7 (0.3 – 1.6) | 0.387 | ||
Yes | 8 (18.2) | 205 (23.3) | ||||
No | 36 (81.2) | 676 (76.3) | ||||
Drugs category ‘D’ | 0.5 (0.1 – 3.6) | 0.485 | 0.6 (0.1 – 3.4) | 0.449 | ||
Yes | 1 (2.3) | 40 (4.5) | ||||
No | 43 (97.7) | 841 (95.5) | ||||
Maturity status at birth | Preterm | Term | ||||
n (%) | n (%) | |||||
Drugs category ‘A’ | 0.6 (0.2 – 1.6) | 0.277 | 0.5 (0.2 – 1.5) | 0.231 | ||
Yes | 45 (91.8) | 835 (95.3) | ||||
No | 4 (8.2) | 41 (4.7) | ||||
Drugs category ‘B’ | 1.5 (0.8 – 2.8) | 0.160 | 1.5 (0.8 – 2.8) | 0.175 | ||
Yes | 17 (34.7) | 224 (25.6) | ||||
No | 32 (65.3) | 652 (74.4) | ||||
Drugs category ‘C’ | 1.4 (0.7 – 2.6) | 0.345 | 1.4 (0.8 – 2.7) | 0.269 | ||
Yes | 14 (28.6) | 199 (22.7) | ||||
No | 35 (71.4) | 677 (77.3) | ||||
Drugs category ‘D’ | 2.0 (0.7 – 5.9) | 0.201 | 2.0 (0.7 – 6.0) | 0.200 | ||
Yes | 4 (8.2) | 37 (4.2) | ||||
No | 45 (91.8) | 839 (95.8) | ||||