Table 1.
Selected cohort characteristics of pregnancies exposed or not exposed to oral fluconazole during the first trimester in Medicaid Analytic eXtract 2000-14
| Characteristic | Unadjusted (n=1 912 907) | Unadjusted (n=119 740) | Adjusted (n=119 736) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| No (%)* exposed to fluconazole | No (%)* not exposed | Standardized difference | No (%)* exposed to fluconazole | No (%)* exposed to topical azoles | Standardized difference | No (%)* exposed to fluconazole | No (%)* exposed to topical azoles | Standardized difference | |||
| Total | 37 650 | 1 875 257 | — | 37 650 | 82 090 | — | 37 649 | 82 087 | — | ||
| Age (mean (SD)) | 25.0 (5.6) | 24.4 (5.9) | 0.11 | 25.0 (5.6) | 24.8 (5.9) | 0.00 | 25.0 (5.6) | 25.0 (5.9) | 0.01 | ||
| Race/ethnicity† | |||||||||||
| White | 14 624 (38.8) | 734 166 (39.2) | −0.01 | 14 624 (38.8) | 26 377 (32.1) | 0.14 | 14 623 (38.8) | 32 295 (39.3) | −0.01 | ||
| Black | 16 651 (44.2) | 595 062 (31.7) | 0.26 | 16 651 (44.2) | 30 196 (36.8) | 0.15 | 16 651 (44.2) | 35 782 (43.6) | 0.01 | ||
| Hispanic | 3260 (8.7) | 301 121 (16.1) | −0.23 | 3260 (8.7) | 14 970 (18.2) | −0.28 | 3260 (8.7) | 7277 (8.9) | −0.01 | ||
| Other or unknown | 3115 (8.3) | 244 908 (13.1) | −0.16 | 3115 (8.3) | 10 547 (12.8) | −0.15 | 3115 (8.3) | 6732 (8.2) | 0.00 | ||
| Treatment indications and related conditions | |||||||||||
| Vaginal candidiasis | 7302 (19.4) | 35 097 (1.9) | 0.59 | 7302 (19.4) | 10 956 (13.3) | 0.16 | 7301 (19.4) | 16 304 (19.9) | −0.01 | ||
| Urinary tract infections | 9885 (26.3) | 248 487 (13.3) | 0.33 | 9885 (26.3) | 16 917 (20.6) | 0.13 | 9885 (26.3) | 21 481 (26.2) | 0.00 | ||
| Other superficial/mucosal candidiasis | 59 (0.2) | 297 (0.0) | 0.05 | 59 (0.2) | 113 (0.1) | 0.01 | 59 (0.2) | 122 (0.1) | 0.00 | ||
| Other candidiasis | 656 (1.7) | 2224 (0.1) | 0.17 | 656 (1.7) | 978 (1.2) | 0.05 | 656 (1.7) | 1441 (1.8) | 0.00 | ||
| Other fungal infections | 379 (1.0) | 6898 (0.4) | 0.08 | 379 (1.0) | 3126 (3.8) | −0.18 | 379 (1.0) | 979 (1.2) | −0.02 | ||
| Other non-fungal infections | 10 608 (28.2) | 278 541 (14.9) | 0.33 | 10 608 (28.2) | 17 545 (21.4) | 0.16 | 10 607 (28.2) | 23 373 (28.5) | −0.01 | ||
| Other maternal conditions | |||||||||||
| Alcohol abuse or dependence | 372 (1.0) | 13 437 (0.7) | 0.03 | 372 (1.0) | 601 (0.7) | 0.03 | 372 (1.0) | 810 (1.0) | 0.00 | ||
| Tobacco use | 2042 (5.4) | 66 448 (3.5) | 0.09 | 2042 (5.4) | 2634 (3.2) | 0.11 | 2042 (5.4) | 4599 (5.6) | −0.01 | ||
| Drug abuse or dependence | 1012 (2.7) | 37 143 (2.0) | 0.05 | 1012 (2.7) | 1562 (1.9) | 0.05 | 1012 (2.7) | 2194 (2.7) | 0.00 | ||
| Chronic renal disease | 74 (0.2) | 1850 (0.1) | 0.03 | 74 (0.2) | 97 (0.1) | 0.02 | 74 (0.2) | 165 (0.2) | 0.00 | ||
| Obesity or overweight | 1577 (4.2) | 42 610 (2.3) | 0.11 | 1577 (4.2) | 2560 (3.1) | 0.06 | 1577 (4.2) | 3409 (4.2) | 0.00 | ||
| Pre-existing hypertension | 1738 (4.6) | 40 889 (2.2) | 0.14 | 1738 (4.6) | 2458 (3.0) | 0.09 | 1738 (4.6) | 3806 (4.6) | 0.00 | ||
| Pre-gestational diabetes | 1644 (4.4) | 28 306 (1.5) | 0.17 | 1644 (4.4) | 2392 (2.9) | 0.08 | 1643 (4.4) | 3643 (4.4) | 0.00 | ||
| Concomitant drug use | |||||||||||
| Oral antibiotics | 24 659 (65.5) | 568 712 (30.3) | 0.75 | 24 659 (65.5) | 43 267 (52.7) | 0.26 | 24 658 (65.5) | 53 819 (65.6) | 0.00 | ||
| Immunosuppressive drugs | 1764 (4.7) | 38 843 (2.1) | 0.15 | 1764 (4.7) | 3223 (3.9) | 0.04 | 1764 (4.7) | 3789 (4.6) | 0.00 | ||
| Antidiabetic drugs | 1058 (2.8) | 15 233 (0.8) | 0.15 | 1058 (2.8) | 1336 (1.6) | 0.08 | 1057 (2.8) | 2347 (2.9) | 0.00 | ||
| Insulin | 1084 (2.9) | 14 420 (0.8) | 0.16 | 1084 (2.9) | 1485 (1.8) | 0.07 | 1084 (2.9) | 2438 (3.0) | −0.01 | ||
| Suspected teratogenic drugs‡ | 3549 (9.4) | 63 349 (3.4) | 0.25 | 3549 (9.4) | 4706 (5.7) | 0.14 | 3548 (9.4) | 7934 (9.7) | −0.01 | ||
| Measures of healthcare use (mean (SD)) | |||||||||||
| Obstetric Morbidity Index | 1.1 (1.6) | 0.9 (1.4) | 0.16 | 1.1 (1.6) | 1.0 (1.5) | 0.10 | 1.1 (1.6) | 1.1 (1.6) | 0.00 | ||
| No of outpatient visits | 3.1 (4.5) | 1.9 (3.5) | 0.28 | 3.1 (4.5) | 2.4 (3.6) | 0.18 | 3.1 (4.5) | 3.1 (4.5) | −0.01 | ||
| No of emergency department visits | 0.5 (1.0) | 0.3 (0.8) | 0.17 | 0.5 (1.0) | 0.4 (0.9) | 0.11 | 0.5 (1.0) | 0.5 (1.0) | 0.00 | ||
| No of distinct diagnoses | 4.2 (3.9) | 2.6 (3.2) | 0.45 | 4.2 (3.9) | 3.2 (3.4) | 0.27 | 4.2 (3.9) | 4.2 (3.9) | 0.00 | ||
| No of distinct prescriptions for drugs other than antifungal drugs | 3.0 (3.2) | 1.6 (2.3) | 0.52 | 3.0 (3.2) | 2.2 (2.7) | 0.29 | 3.0 (3.2) | 2.9 (3.0) | 0.02 | ||
SD=standard deviation.
*
Percentages might not total 100 because of rounding. For simplicity, most clinically relevant characteristics are listed (see eTable 4 for complete baseline table).
†
Race/ethnicity was determined based on information submitted to the Centers for Medicare and Medicaid Services by individual states, based on information collected and coded from Medicaid applications.
‡
Suspected teratogenic drugs include methimazole, danazol, propylthiouracil, aminoglycosides, folic acid antagonists, potassium iodide, and tetracycline.