Outcome | Country (recruited women relevant to each subgroup with birth data available in intervention; control groups) | Intervention sites | Control sites | Risk ratio [95% CI] or Mean Difference [95% CI] |
---|---|---|---|---|
Intrauterine death before 24 weeks (% with birthing data) | Trial as a whole (1174; 782) | 7 (0.6) | 3 (0.4) | 1.22 [0.36, 4.11] |
Germany (458; 282) | 0 (0.0) | 1 (0.4) | 0.38 [0.02, 9.27] | |
Ireland (365; 250) | 6 (1.6) | 0 (0) | 6.45 [0.37, 113.52] | |
Italy (351; 250) | 1 (0.3) | 2 (0.8) | 0.50 [0.07, 3.36] | |
Intrauterine death after 24 weeks (% with birthing data) | Trial as a whole (1174; 782) | 4 (0.2) | 2 (0.2) | 1.16 [0.28, 4.83] |
Germany (458; 282) | 1 (0.2) | 1 (0.4) | 0.66 [0.08, 5.78] | |
Ireland (365; 250) | 1 (0.3) | 1 (0.4) | 1.08 [0.07, 17.15] | |
Italy (351; 250) | 2 (0.6) | 0 (0) | 2.97 [0.14, 61.50] | |
Neonatal death (% of live-born) | Trial as a whole (1163; 777) | 0 (0) | 2 (0.3) | 0.26 [0.03, 2.34] |
Germany (457; 280) | 0 (0) | 1 (0.4) | 0.38 [0.02, 9.15] | |
Ireland (358; 249) | 0 (0) | 1 (0.4) | 0.17 [0.01, 4.13] | |
Italy (348; 248) | 0 (0) | 0 (0) | No data | |
Live-born before 37 weeks (% of live-born)a | Trial as a whole (1163; 777) | 62 (5.3) | 50 (6.4) | 0.81 [0.56, 1.17] |
Germany (457; 280) | 18 (3.9) | 16 (5.7) | 0.61 [0.31, 1.21] | |
Ireland (358; 249) | 19 (5.3) | 10 (4.0) | 1.23 [0.59, 2.56] | |
Italy (348; 248) | 25 (7.2) | 24 (9.7) | 0.77 [0.45, 1.32] | |
Gestational age at live birth (mean, SD)a | Trial as a whole (1163; 777) | 38.9 (1.5) | 38.7 (1.8) | 0.15 [0.00, 0.30] |
Germany (457; 280) | 38.9 (1.4) | 39.0 (1.8) | −0.10 [−0.35, 0.15] | |
Ireland (358; 249) | 39.1 (1.5) | 39.0 (1.7) | 0.10 [−0.16, 0.36] | |
Italy (348; 248) | 38.6 (1.7) | 38.1 (1.6) | 0.50 [0.23, 0.77] | |
Admission to NICU (% of live-born) | Trial as a whole (1163; 777) | 90 (7.7) | 63 (8.1) | 0.87 [0.64, 1.17] |
Germany (457; 280) | 34 (7.4) | 28 (10.0) | 0.58 [0.35, 0.95] | |
Ireland (358; 249) | 40 (11.2) | 28 (11.2) | 0.97 [0.62, 1.51] | |
Italy (348; 248) | 16 (4.6) | 7 (2.8) | 1.70 [0.73, 3.93] |