Adverse event | 16-18 weeks’ gestation N (%) | 22-24 weeks’ gestation N (%) | 32-34 weeks’ gestation N (%) | 36-37 weeks’ gestation N (%) | ||||
---|---|---|---|---|---|---|---|---|
INT | UC | INT | UC | INT | UC | INT | UC | |
N = 199 | N = 117 | N = 194 | N = 115 | N = 188 | N = 112 | N = 172 | N = 108 | |
Nausea | 7 (3.5) | - | 2 (1.0) | - | 1 (0.5) | - | 1 (0.6) | - |
Vaginal bleeding | - | - | - | - | 1 (0.5) | - | - | 1 (0.9) |
Painful contractions | - | - | - | 4 (3.5) | - | 8 (7.1) | 1 (0.6) | 7 (6.6) |
Dizziness | 6 (3.0) | 3 (2.6) | 4 (2.1) | 1 (0.9) | 1 (0.5) | 3 (2.7) | 1 (0.6) | - |
Dyspnea | 7 (3.5) | 8 (6.8) | 3 (1.5) | 10 (8.7) | 4 (2.1) | 14 (12.5) | 7 (4.1) | 16 (14.8) |
Headache | 1 (0.5) | - | 1 (0.5) | - | - | - | 2 (1.2) | - |
Chest pain | - | - | - | - | - | - | - | - |
Profound fatigue or weakness | - | 1 (0.9) | - | 4 (3.5) | 2 (1.1) | 2 (1.8) | - | 2 (1.9) |
Calf pain or swelling | - | - | 2 (1.0) | 1 (0.9) | 1 (0.5) | 1 (0.9) | - | 1 (0.9) |
Musculoskeletal symptoms | 13 (6.5) | 5 (4.3) | 17 (8.8) | 6 (5.2) | 25 (13.3) | 7 (6.3) | 24 (14.0) | 7 (6.5) |
Painless contractions | 4 (2.0) | - | 10 (5.2) | - | 29 (15.4) | 2 (1.8) | 18 (10.5) | 2 (1.9) |
Cramps | 1 (0.5) | - | 1 (0.5) | - | 2 (1.1) | - | - | - |
Miscellaneous2) | 12 (6.0) | 8 (7.8) | 22 (11.3) | 13 (11.4) | 23 (12.2) | 14 (12.6) | 16 (9.3) | 14 (13.1) |
At least one adverse event | 59 (30.1) | 23 (20.2) | 61 (31.9) | 32 (28.8) | 87 (46.8) | 39 (36.1) | 67 (39.2) | 38 (36.2) |
Group difference 95% CI (p-value)3) | 0.89 to 3.88 (0.10) | 0.62 to 2.43 (0.56) | 0.99 to 2.94 (0.05) | 0.74 to 2.16 (0.37) |