Table 2.
Adverse perinatal outcomes in exposed women and the matched comparison group, stratified by therapy comparison. Data presented are numbers (percentage) of outcomes and hazard ratios (95% confidence interval)
| Aim 1 | Aim 2 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bupropion vs unexposed | Varenicline vs unexposed | NRT vs unexposed | Varenicline vs NRT | |||||||||
| Bupropion | Unexposed# | HR (95% CI)† | Varenicline | Unexposed# | HR (95% CI)† | NRT | Unexposed# | HR (95% CI)† | Varenicline | NRT# | HR (95% CI) | |
| Any adverse outcome | 91 (39.2%) | 912 (39.3%) | 0.93 (0.73–1.19) | 390 (36.9%) | 4240 (40.1%) | 0.86 (0.77–0.97) | 147 (44.8%) | 1520 (46.3%) | 1.02 (0.84–1.23) | 67 (38.7%) | 89 (51.4%) | 0.58 (0.33–1.05)‡ |
| Preterm | 12 (5.2%) | 192 (8.3%) | 0.62 (0.34–1.11) | 69 (6.5%) | 941 (8.9%) | 0.72 (0.56–0.92) | 36 (11.0%) | 358 (10.9%) | 1.00 (0.71–1.42) | 6 (3.5%) | 21 (12.1%) | 0.29 (0.12–0.71)† |
| Small for gestation age* | 37 (16.2%) | 369 (16.1%) | 0.89 (0.60–1.30) | 119 (11.4%) | 1612 (15.4%) | 0.68 (0.56–0.83) | 47 (14.4%) | 578 (17.7%) | 0.77 (0.56–1.07) | 26 (15.3%) | 25 (14.7%) | 1.09 (0.48–2.47)† |
| Admission to special neonatal care* | 32 (14.0%) | 325 (14.2%) | 0.90 (0.62–1.32) | 163 (15.6%) | 1622 (15.5%) | 0.95 (0.80–1.13) | 66 (20.2%) | 692 (21.2%) | 0.97 (0.74–1.26) | 22 (12.9%) | 38 (22.4%) | 0.59 (0.32–1.10)† |
| Severe neonatal morbidity complications* | 15 (6.6%) | 157 (6.9%) | 0.87 (0.50–1.52) | 69 (6.6%) | 855 (8.2%) | 0.74 (0.57–0.96) | 27 (8.3%) | 345 (10.6%) | 0.82 (0.55–1.23) | 13 (7.6%) | 19 (11.2%) | 0.60 (0.26–1.37)† |
| Emergency caesarean | 34 (14.7%) | 289 (12.5%) | 1.15 (0.78–1.71) | 123 (11.6%) | 1310 (12.4%) | 0.88 (0.71–1.08) | 37 (11.3%) | 421 (12.8%) | 1.01 (0.70–1.45) | 20 (11.6%) | 26 (15.0%) | 0.47 (0.20–1.09)† |
| Severe maternal morbidity complications | 5 (2.2%) | 49 (2.1%) | 0.95 (0.37–2.43) | 17 (1.6%) | 172 (1.6%) | 0.92 (0.53–1.59) | 10 (3.0%) | 79 (2.4%) | 1.22 (0.60–2.46) | 6 (3.5%) | 6 (3.5%) | 0.75 (0.17–3.35)† |
| PPROM | < 5 | 73 (3.1%) | – | 36 (3.4%) | 360 (3.4%) | 1.02 (0.72–1.44) | 16 (4.9%) | 139 (4.2%) | 1.15 (0.68–1.94) | < 5 | 9 (5.2%) | – |
| Apgar 5 min < 7* | < 5 | 44 (1.9%) | – | 14 (1.3%) | 288 (2.8%) | 0.47 (0.27–0.81) | 6 (1.8%) | 105 (3.2%) | 0.59 (0.25–1.37) | < 5 | 5 (2.9%) | – |
| Placenta abruption | < 5 | 15 (0.6%) | – | 9 (0.9%) | 97 (0.9%) | 0.97 (0.49–1.93) | < 5 | 34 (1.0%) | – | 0 (0%) | 0 (0%) | – |
| Perinatal death | < 5 | 19 (0.8%) | – | 13 (1.2%) | 122 (1.2%) | 1.01 (0.57–1.80) | < 5 | 30 (0.9%) | – | < 5 | < 5 | – |
*Among live births
#Reference group
†For aim 1, hazard ratio was obtained from the univariate model. For aim 2, multivariable model did not converge; thus, univariate hazard ratio was reported
‡Hazard ratio was obtained from the multivariable Cox model which further adjusted for maternal age, having a partner, private health insurance, socio-economic disadvantage, previous caesarean section, prior hospitalisation, mental health, anaemia and coagulation disorders, and drug and alcohol disorders. In the matched sample, these co-variables had standardised difference > 0.10 and frequency ≥ 5