Table 1 Demographic and clinical characteristics of exposed women and matched comparison group, stratified by therapy comparison. Data are numbers (percentages) and standardised differences
| Â | Aim 1 | Aim 2 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bupropion vs unexposed | Varenicline vs unexposed | NRT vs unexposed | Varenicline 1st trimester vs unexposed | Varenicline vs NRT | |||||||||||
Bupropion | Unexposed | Diff* | Varenicline | Unexposed | Diff* | NRT | Unexposed†| Diff* | Varenicline | Unexposed | Diff* | Varenicline†| NRT | Diff* | |
Total number | 232 | 2320 | Â | 1057 | 10,570 | Â | 328 | 3280 | Â | 696 | 6960 | Â | 173 | 173 | Â |
State of delivery | |||||||||||||||
 New South Wales | 177 (76.3%) | 1819 (78.4%) | 0.05 | 801 (75.8%) | 8109 (76.7%) | 0.02 | 248 (75.6%) | 2484 (75.7%) | 0.00 | 696 (100%) | 6960 (100%) |  | 131 (75.7%) | 127 (73.4%) | 0.05 |
 Western Australia | 55 (23.7%) | 501 (21.6%) | 0.05 | 256 (24.2%) | 2461 (23.3%) | 0.02 | 80 (24.4%) | 796 (24.3%) | 0.00 |  |  |  | 42 (24.3%) | 46 (26.6%) | 0.05 |
Year of conception | |||||||||||||||
 2004 | 39 (16.8%) | 389 (16.8%) | 0.00 |  |  |  |  |  |  |  |  |  |  |  |  |
 2005 | 59 (25.4%) | 613 (26.4%) | 0.02 |  |  |  |  |  |  |  |  |  |  |  |  |
 2006 | 42 (18.1%) | 391 (16.9%) | 0.03 |  |  |  |  |  |  |  |  |  |  |  |  |
 2007 | 45 (19.4%) | 483 (20.8%) | 0.04 |  |  |  |  |  |  |  |  |  |  |  |  |
 2008 | 17 (7.3%) | 194 (8.4%) | 0.04 | 179 (16.9%) | 1699 (16.1%) | 0.02 |  |  |  | 116 (16.7%) | 1057 (15.2%) | 0.04 |  |  |  |
 2009 | 7 (3.0%) | 75 (3.2%) | 0.01 | 270 (25.5%) | 2666 (25.2%) | 0.01 | 9 (2.7%) | 73 (2.2%)†| 0.03 | 169 (24.3%) | 1740 (25.0%) | 0.02 |  |  |  |
 2010 | 12 (5.2%) | 93 (4.0%) | 0.06 | 315 (29.8%) | 3153 (29.8%) | 0.00 | 47 (14.3%) | 412 (12.6%)†| 0.05 | 220 (31.6%) | 2200 (31.6%) | 0.00 | 21 (12.2%)†, § | 22 (12.7%) § | 0.02 |
 2011 | 11 (4.7%)# | 82 (3.6%)# | 0.05 | 239 (22.6%) | 2480 (23.5%) | 0.02 | 212 (64.6%) | 2228 (67.9%) | 0.07 | 155 (22.3%) | 1643 (23.6%) | 0.03 | 123 (71.1%) | 116 (67.1%) | 0.09 |
 2012 |  |  |  | 54 (5.1%) | 572 (5.4%) | 0.01 | 60 (18.3%) | 567 (17.3%) | 0.03 | 36 (5.2%) | 320 (4.6%) | 0.03 | 29 (16.8%) | 35 (20.2%) | 0.09 |
Maternal age (conception) | |||||||||||||||
 Under 25 | 61 (26.3%) | 589 (25.4%) | 0.02 | 332 (31.4%) | 3341 (31.6%) | 0.00 | 94 (28.7%) | 910 (27.7%) | 0.02 | 215 (30.9%) | 2172 (31.2%) | 0.01 | 57 (32.9%) | 47 (27.2%) | 0.13 |
 25–29 | 76 (32.8%) | 792 (34.1%) | 0.03 | 318 (30.1%) | 3132 (29.6%) | 0.01 | 99 (30.2%) | 1060 (32.3%) | 0.05 | 230 (33.0%) | 2177 (31.3%) | 0.04 | 53 (30.6%) | 54 (31.2%) | 0.01 |
 30–34 | 61 (26.3%) | 602 (25.9%) | 0.01 | 227 (21.5%) | 2360 (22.3%) | 0.02 | 84 (25.6%) | 819 (25.0%) | 0.01 | 133 (19.1%) | 1418 (20.4%) | 0.03 | 34 (19.7%) | 41 (23.7%) | 0.10 |
 35 and older | 34 (14.7%) | 337 (14.5%) | 0.00 | 180 (17.0%) | 1737 (16.4%) | 0.02 | 51 (15.5%) | 491 (15.0%) | 0.02 | 118 (17.0%) | 1193 (17.1%) | 0.00 | 29 (16.8%) | 31 (17.9%) | 0.03 |
Aboriginal | 9 (3.9%) | 110 (4.7%) | 0.04 | 101 (9.6%) | 926 (8.8%) | 0.03 | 93 (28.4%) | 875 (26.7%) | 0.04 | 71 (10.2%) | 648 (9.3%) | 0.03 | 32 (18.5%) | 36 (20.8%) | 0.06 |
Overseas born | 35 (15.1%) | 367 (15.8%) | 0.02 | 180 (17.0%) | 1815 (17.2%) | 0.00 | 24 (7.3%) | 206 (6.3%) | 0.04 | 104 (14.9%) | 1015 (14.6%) | 0.01 | 26 (15.0%) | 11 (6.4%) | 0.28 |
Had a partner | 173 (74.6%) | 1764 (76.0%) | 0.03 | 719 (68.0%) | 7218 (68.3%) | 0.01 | 179 (54.6%) | 1792 (54.6%) | 0.00 | 452 (64.9%) | 4584 (65.9%) | 0.02 | 119 (68.8%) | 91 (52.6%) | 0.34 |
Private health insurance | 34 (14.7%) | 288 (12.4%) | 0.07 | 141 (13.3%) | 1435 (13.6%) | 0.01 | 23 (7.0%) | 207 (6.3%) | 0.03 | 87 (12.5%) | 836 (12.0%) | 0.01 | 20 (11.6%) | 10 (5.8%) | 0.21 |
Socio-economic disadvantage‡ | |||||||||||||||
 Quintile 1 (most disadvantaged) | 48 (20.7%) | 519 (22.4%) | 0.04 | 172 (16.3%) | 1722 (16.3%) | 0.00 | 53 (16.2%) | 479 (14.6%) | 0.04 | 123 (17.7%) | 1264 (18.2%) | 0.01 | 33 (19.1%) | 26 (15.0%) | 0.11 |
 Quintile 2 | 39 (16.8%) | 411 (17.7%) | 0.02 | 164 (15.5%) | 1629 (15.4%) | 0.00 | 62 (18.9%) | 644 (19.6%) | 0.02 | 112 (16.1%) | 1073 (15.4%) | 0.02 | 23 (13.3%) | 41 (23.7%) | 0.27 |
 Quintile 3 | 46 (19.8%) | 445 (19.2%) | 0.02 | 263 (24.9%) | 2546 (24.1%) | 0.02 | 84 (25.6%) | 875 (26.7%) | 0.02 | 201 (28.9%) | 1948 (28.0%) | 0.02 | 40 (23.1%) | 37 (21.4%) | 0.04 |
 Quintile 4 | 54 (23.3%) | 524 (22.6%) | 0.02 | 289 (27.3%) | 3024 (28.6%) | 0.03 | 91 (27.7%) | 873 (26.6%) | 0.03 | 173 (24.9%) | 1763 (25.3%) | 0.01 | 44 (25.4%) | 46 (26.6%) | 0.03 |
 Quintile 5 (least disadvantaged) | 45 (19.4%) | 421 (18.1%) | 0.03 | 169 (16.0%) | 1649 (15.6%) | 0.01 | 38 (11.6%) | 409 (12.5%) | 0.03 | 87 (12.5%) | 912 (13.1%) | 0.02 | 33 (19.1%) | 23 (13.3%) | 0.16 |
Remoteness of residence | |||||||||||||||
 Major cities | 135 (58.2%) | 1374 (59.2%) | 0.02 | 592 (56.0%) | 5927 (56.1%) | 0.00 | 170 (51.8%) | 1677 (51.1%) | 0.01 | 440 (63.2%) | 4451 (64.0%) | 0.02 | 96 (55.5%) | 93 (53.8%) | 0.03 |
 Inner regional | 63 (27.2%) | 598 (25.8%) | 0.03 | 339 (32.1%) | 3474 (32.9%) | 0.02 | 118 (36.0%) | 1257 (38.3%) | 0.05 | 200 (28.7%) | 1999 (28.7%) | 0.00 | 57 (32.9%) | 62 (35.8%) | 0.06 |
 Outer regional, remote, very remote | 34 (14.7%) | 348 (15.0%) | 0.01 | 126 (11.9%) | 1169 (11.1%) | 0.03 | 40 (12.2%) | 346 (10.5%) | 0.05 | 56 (8.0%) | 510 (7.3%) | 0.03 | 20 (11.6%) | 18 (10.4%) | 0.04 |
Parity | |||||||||||||||
 Nulliparous | 65 (28.0%) | 699 (30.1%) | 0.05 | 299 (28.3%) | 3022 (28.6%) | 0.01 | 73 (22.3%) | 751 (22.9%) | 0.02 | 221 (31.8%) | 2197 (31.6%) | 0.00 | 46 (26.6%) | 41 (23.7%) | 0.07 |
 Multiparous (1 to 4) | 152 (65.5%) | 1466 (63.2%) | 0.05 | 709 (67.1%) | 7122 (67.4%) | 0.01 | 237 (72.3%) | 2367 (72.2%) | 0.00 | 455 (65.4%) | 4587 (65.9%) | 0.01 | 116 (67.1%) | 122 (70.5%) | 0.07 |
 Grand multiparous (≥ 5) | 15 (6.5%) | 155 (6.7%) | 0.01 | 49 (4.6%) | 426 (4.0%) | 0.03 | 18 (5.5%) | 162 (4.9%) | 0.02 | 20 (2.9%) | 176 (2.5%) | 0.02 | 11 (6.4%) | 10 (5.8%) | 0.02 |
Previous caesarean section | 33 (14.2%) | 290 (12.5%) | 0.05 | 175 (16.6%) | 1663 (15.7%) | 0.02 | 69 (21.0%) | 626 (19.1%) | 0.05 | 109 (15.7%) | 1048 (15.1%) | 0.02 | 28 (16.2%) | 37 (21.4%) | 0.13 |
Hospitalisation in 12 months prior | |||||||||||||||
 Nil | 187 (80.6%) | 1901 (81.9%) | 0.03 | 856 (81.0%) | 8655 (81.9%) | 0.02 | 254 (77.4%) | 2608 (79.5%) | 0.05 | 560 (80.5%) | 5754 (82.7%) | 0.06 | 142 (82.1%) | 132 (76.3%) | 0.14 |
 Once | 35 (15.1%) | 327 (14.1%) | 0.03 | 151 (14.3%) | 1418 (13.4%) | 0.03 | 54 (16.5%) | 502 (15.3%) | 0.03 | 101 (14.5%) | 870 (12.5%) | 0.06 | 23 (13.3%) | 27 (15.6%) | 0.07 |
 Two or more | 10 (4.3%) | 92 (4.0%) | 0.02 | 50 (4.7%) | 497 (4.7%) | 0.00 | 20 (6.1%) | 170 (5.2%) | 0.04 | 35 (5.0%) | 336 (4.8%) | 0.01 | 8 (4.6%) | 14 (8.1%) | 0.14 |
Morbidities | |||||||||||||||
 Mental health | 57 (24.6%) | 534 (23.0%) | 0.04 | 229 (21.7%) | 2162 (20.5%) | 0.03 | 131 (39.9%) | 1224 (37.3%) | 0.05 | 156 (22.4%) | 1502 (21.6%) | 0.02 | 39 (22.5%) | 75 (43.4%) | 0.45 |
 Chronic airway | 45 (19.4%) | 416 (17.9%) | 0.04 | 168 (15.9%) | 1419 (13.4%) | 0.07 | 57 (17.4%) | 516 (15.7%) | 0.04 | 119 (17.1%) | 1069 (15.4%) | 0.05 | 22 (12.7%) | 28 (16.2%) | 0.10 |
 Gastro-oesophageal reflux | 16 (6.9%) | 149 (6.4%) | 0.02 | 66 (6.2%) | 585 (5.5%) | 0.03 | 13 (4.0%) | 137 (4.2%) | 0.01 | 56 (8.0%) | 486 (7.0%) | 0.04 | 11 (6.4%) | 8 (4.6%) | 0.08 |
 Use of NSAIDS | 23 (9.9%) | 206 (8.9%) | 0.04 | 61 (5.8%) | 510 (4.8%) | 0.04 | 23 (7.0%) | 197 (6.0%) | 0.04 | 54 (7.8%) | 481 (6.9%) | 0.03 | 7 (4.0%) | 9 (5.2%) | 0.06 |
 Use of steroids | 11 (4.7%) | 92 (4.0%) | 0.04 | 30 (2.8%) | 243 (2.3%) | 0.03 | 14 (4.3%) | 104 (3.2%) | 0.06 | 25 (3.6%) | 239 (3.4%) | 0.01 | < 5 | 5 (2.9%) | 0.04 |
 Anaemia and coagulation | 10 (4.3%) | 108 (4.7%) | 0.02 | 26 (2.5%) | 223 (2.1%) | 0.02 | 13 (4.0%) | 124 (3.8%) | 0.01 | 16 (2.3%) | 141 (2.0%) | 0.02 | 5 (2.9%) | 9 (5.2%) | 0.12 |
 Drug and alcohol disorder | 7 (3.0%) | 59 (2.5%) | 0.03 | 25 (2.4%) | 230 (2.2%) | 0.01 | 30 (9.1%) | 251 (7.7%) | 0.05 | 19 (2.7%) | 169 (2.4%) | 0.02 | 5 (2.9%) | 21 (12.1%) | 0.36 |
 Thyroid | < 5 | 21 (0.9%) | 0.04 | 8 (0.8%) | 79 (0.7%) | 0.00 | 5 (1.5%) | 52 (1.6%) | 0.00 | 8 (1.1%) | 62 (0.9%) | 0.03 | < 5 | < 5 |  |
 Cardiovascular | < 5 | 5 (0.2%) | 0.04 | 12 (1.1%) | 113 (1.1%) | 0.01 | 6 (1.8%) | 70 (2.1%) | 0.02 | 10 (1.4%) | 87 (1.3%) | 0.02 | < 5 | 5 (2.9%) | 0.18 |
 Pre-existing diabetes | < 5 | 12 (0.5%) | 0.01 | 13 (1.2%) | 114 (1.1%) | 0.01 | 5 (1.5%) | 45 (1.4%) | 0.01 | < 5 | 55 (0.8%) | 0.03 | < 5 | 5 (2.9%) | 0.04 |
 Pre-existing hypertension | < 5 | 12 (0.5%) | 0.04 | 11 (1.0%) | 96 (0.9%) | 0.01 | 6 (1.8%) | 45 (1.4%) | 0.04 | 6 (0.9%) | 57 (0.8%) | 0.00 | < 5 | < 5 | 0.15 |
 Epilepsy | < 5 | 9 (0.4%) | 0.01 | 8 (0.8%) | 64 (0.6%) | 0.02 | 8 (2.4%) | 65 (2.0%) | 0.03 | 5 (0.7%) | 60 (0.9%) | 0.02 | < 5 | 5 (2.9%) | 0.18 |
 Chronic renal disease | < 5 | 27 (1.2%) | 0.03 | 5 (0.5%) | 42 (0.4%) | 0.01 | < 5 | 43 (1.3%) | 0.01 | < 5 | 30 (0.4%) | 0.02 | < 5 | < 5 | 0.06 |