Table 5.
Incidence of early neurodevelopmental disorders during follow-up according to exposure to pregabalin during pregnancy (compared to unexposed children) in the overall study population and among children born to a mother with no known mental illness.
| Overall population | Children born to a mother with no known mental illness | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Children exposed to pregabalin during pregnancy (N = 1,627) |
Unexposed children (N = 1,710,441) |
aHR [95%CI]* | Children exposed to pregabalin during pregnancy (N = 674) |
Unexposed children (N = 1,382,288) |
aHR [95%CI]** | |||||
| N | IR per 1,000 PY |
N | IR per 1,000 PY |
N | IR per 1,000 PY |
N | IR per 1,000 PY |
|||
| Diagnosis | ||||||||||
| Mental and behavioural disorders (F70–F98) | 28 | 5.0 | 15,270 | 2.5 | 1.5 [1.0–2.1]a | 7 | 3.1 | 11,012 | 2.2 | 1.3 [0.6–2.7] |
| Pervasive developmental disorders (F84) | 7 | 1.2 | 4,280 | 0.7 | 1.4 [0.7–2.9] | 1 | 0.4 | 3,131 | 0.6 | 0.7 [0.1–4.8] |
| Mental retardation (F70–F79) | 7 | 1.2 | 3,398 | 0.6 | 1.7 [0.8–3.6] | 4 | 1.7 | 2,544 | 0.5 | 3.1 [1.2–8.3] |
| Disorders of psychological development (F80–F89) | 16 | 2.9 | 10,010 | 1.6 | 1.3 [0.8–2.2] | 4 | 1.7 | 7,315 | 1.5 | 1.1 [0.4–3.0] |
| Behavioural and emotional disorders with onset usually occurring in childhood and adolescence (F90–F98) | 9 | 1.6 | 4,398 | 0.7 | 1.4 [0.8–2.8] | 2 | 0.9 | 2,976 | 0.6 | 1.4 [0.3–5.5] |
| Health care utilization | ||||||||||
| Speech therapy | 61 | 11.0 | 72,012 | 11.9 | 0.9 [0.7–1.2] | 24 | 10.5 | 55,532 | 11.3 | 1.0 [0.7–1.5] |
| Orthoptics | 225 | 43.3 | 203,489 | 35.6 | 1.2 [1.1–1.4] | 98 | 46.0 | 162,427 | 35.3 | 1.4 [1.1–1.6] |
| Psychiatry | 23 | 4.1 | 22,365 | 3.7 | 0.9 [0.6–1.3] | 7 | 3.1 | 16,018 | 3.3 | 1.0 [0.5–2.1] |
Bold values indicate statistically significant associations, i.e. with a p-value ≤ 0.05.
IR Incidence rate, HR hazard ratio, 95% CI 95% confidence interval.
*Cox models adjusted for: mother’s age, Complementary Universal Health Insurance scheme, diagnosis of mental illness other than tobacco and alcohol use disorders, antipsychotics during the year preceding pregnancy, indicator of severity of psychiatric morbidity, indicator of tobacco use, indicator of alcohol use, folic acid, SSRI during pregnancy, child’s sex, gestational age and birth weight.
**Cox models adjusted for: mother’s age, Complementary Universal Health Insurance scheme, indicator of tobacco use, indicator of alcohol use, folic acid, child’s sex, gestational age and birth weight.
ap = 0.04.