TABLE 4.
Association between CQ/HCQ exposure during the first trimester and the risk of overall major congenital malformations.
| Major congenital malformation | ||||
|---|---|---|---|---|
| Variables | Yes n = 25,351 | No n = 208,397 | Crude OR (95% CI) | Adjusted OR (95% CI) |
| n (%) | ||||
| Study medication exposures during the 1st trimester: | ||||
| CQ/HCQ | 26 (0.10) | 192 (0.09) | 117 (0.06) | 1.01 (0.67–1.52) |
| Other antimalarial medicationsa | 12 (0.05) | 1.11 (0.74–1.67) | 0.84 (0.47–1.52) | 0.84 (0.47–1.51) |
| Maternal age at the 1DGb - mean (SD) | 28.08 ± 5.57 | 28.24 ± 5.59 | 0.99 (0.99–1.00) | 0.99 (0.99–1.00) |
| Adherent vs. welfare recipient | 19,479 (76.84) | 160,858 (77.19) | 0.98 (0.95–1.01) | 1.02 (0.99–1.05) |
| Urban dweller | 21,888 (83.24) | 171,392 (82.18) | 1.07 (1.03–1.11) | 1.05 (1.02–1.09) |
| Diagnosis during pregnancy for: | ||||
| SLEc | 16 (0.06) | 159 (0.08) | 0.82 (0.50–1.36) | 0.73 (0.44–1.20) |
| Malaria | 4 (0.02) | 56 (0.03) | 0.59 (0.21–1.62) | 0.54 (0.20–1.50) |
| Rheumatoid arthritis | 70 (0.28) | 364 (0.17) | 1.58 (1.22–2.05) | 1.49 (1.14–1.94) |
| Comorbiditiesb | ||||
| Hypertension | 736 (2.90) | 5,251 (2.52) | 1.15 (1.06–1.25) | 1.08 (1.00–1.17) |
| Diabetes | 667 (2.63) | 4,637 (2.23) | 1.18 (1.09–1.29) | 1.10 (1.01–1.20) |
| Asthma | 3,343 (13.19) | 24,930 (11.96) | 1.12 (1.07–1.16) | 1.06 (1.01–1.10) |
| Thyroid disorders | 1,223 (4.82) | 9,158 (4.39) | 1.10 (1.04–1.17) | 1.06 (1.00–1.13) |
| Diagnosis of dependence to: | ||||
| Tobacco | 879 (3.47) | 6,499 (3.12) | 1.11 (1.04–1.20) | 1.09 (1.01–1.17) |
| Alcohol | 111 (0.44) | 8,185 (0.39) | 1.12 (0.92–1.37) | 0.99 (0.81–1.22) |
| Other drugs | 304 (1.20) | 2,089 (1.00) | 1.20 (1.06–1.35) | 1.14 (1.00–1.29) |
| HIV drugd use during the 1st trimester: | 34 (0.13) | 172 (0.08) | 1.62 (1.10–2.38) | 1.51 (1.02–2.23) |
| In the year prior to the 1DG: | ||||
| Emergency visit or hospitalization | 9,004 (35.52) | 70,496 (33.83) | 1.08 (1.05–1.11) | 1.00 (0.97–1.03) |
| General practitioner visit | ||||
| 0 | 4,918 (19.40) | 44,521 (21.36) | Ref. | Ref. |
| 1–3 | 9,469 (37.35) | 78,996 (37.91) | 1.08 (1.05–1.12) | 1.01 (0.98–1.05) |
| 4 or more | 10,964 (43.25) | 84,880 (40.73) | 1.17 (1.13–1.21) | 1.04 (1.01–1.08) |
| Specialist visits | ||||
| 0 | 9,229 (36.40) | 82,504 (39.59) | Ref. | Ref. |
| 1–2 | 6,419 (25.32) | 51,780 (24.85) | 1.11 (1.07–1.15) | 1.06 (1.02–1.10) |
| 3 or more | 9,703 (38.27) | 74,113 (35.56) | 1.17 (1.13–1.20) | 1.10 (1.06–1.15) |
| Other prescribed medicationse | ||||
| 0 | 7,115 (28.07) | 62,534 (30.01) | Ref. | Ref. |
| 1–2 | 8,508 (33.56) | 71,490 (34.30) | 1.05 (1.01–1.08) | 1.07 (1.03–1.11) |
| 3 or more | 9,728 (38.37) | 74,373 (35.69) | 1.15 (1.11–1.19) | 1.09 (1.05–1.13) |
| Pregnancy follow-up by obstetrician | 15,304 (60.37) | 118,389 (56.81) | 1.16 (1.13–1.19) | 1.15 (0.90–0.99) |
| Pregnancy in the year prior to 1DG | 2,188 (8.63) | 17,917 (8.60) | 1.00 (0.96–1.05) | 0.94 (1.00–1.15) |
| Folic acid consumption before the end of the 1st trimester | 1,051 (4.15) | 7,721 (3.70) | 1.12 (1.05–1.20) | 1.07 |
Atovaquone, mefloquine, primaquine, proguanil, sulfadoxine-pyrimethamine, and halofantrine.
First day of gestation defined as the first day of the last menstrual period (LMP).
Systemic lupus erythematosus.
Alone or combined: abacavir, adefovir dipivoxil, atazanavir, AZT, bictegravir, cobicistat, darunavir, delavirdine, didanosine, dolutegravir, doravirine, efavirenz, elvitegravir, emtricitabine, enfuvirtide, etravirine, fosamprenavir, indinavir, lamivudine, lopinavir, maraviroc, nelfinavir, nevirapine, raltegravir, retrovir, rilpivirine, ritonavir, saquinavir, stavudine, tenofovir disoproxil, tenofovir alafenamide, tipranavir, and zidovudine.
Other prescribed medications than the study medications and medications used to assess the maternal co-morbidities prior pregnancy.