Table 2.
Birth Outcomes
| Characteristic | Control Group | Treatment Group | P |
|---|---|---|---|
| Duration of pregnancy | |||
| Primary outcome | |||
| Less than 37 wk (missing considered preterm) | 104/903 (11.5) | 118/903 (13.1) | .316 |
| Less than 37 wk (missing not included) | 81/880 (9.2) | 97/882 (11.0) | .212 |
| Secondary outcomes | |||
| Less than 35 wk | 41/880 (4.7) | 41/882 (4.6) | .992 |
| Less than 32 wk | 22/880 (2.5) | 25/882 (3.0) | .663 |
| Mean birth weight (g) GA less than 37 wk | 79 (2,027±810) | 94 (2,118±803) | .438 |
| Composite outcome of neonatal morbidity and mortality* | 41/878 (4.7) | 39/882 (4.4) | .803 |
| Other outcomes | |||
| Birth weight GA less than 37 wk adjusting for race, sex, and GA | 78 (2,085±38.6)* | 92 (2,080±35.4)* | .923 |
| Mean birth weight (g) GA more than 37 wk | 796 (3,333±488) | 784 (3,344±478) | .863† |
| Birth weight (excludes miscarriages/stillbirths) | |||
| Total birth weight (g) | 866 (3,241±590) | 872 (3,227±612) | .694 |
| Less than 2,500 g | 71/866 (8.2) | 72/872 (8.3) | .965 |
| Less than 1,500 g | 13/866 (1.5) | 15/872 (1.7) | .717 |
| Small for gestational age (10th percentile) | 119/867 (13.7) | 98/872 (11.2) | .117 |
| Birth length (cm) | 842 (49.6±3.5) | 842 (49.6±3.5) | .826† |
| Apgar score at 5 min | |||
| 0–3 | 6/852 (0.7) | 5/857 (0.6) | .627 |
| 4–7 | 25/852 (2.9) | 21/857 (2.5) | |
| 8–10 | 821/852 (96.4) | 831/857 (97.0) | |
| Admission to neonatal intensive care unit | |||
| Total number admitted | 85/873 (9.7) | 84/877 (9.6) | .911 |
| Length of stay more than 2 d | 71/83 (85.5) | 62/76 (81.6) | .500 |
| Discharged alive | 84/85 (98.8) | 78/81 (96.3) | .289 |
| Live births | |||
| Preterm | 871/880 (99.1) | 874/881 (99.2) | .614 |
| Less than 32 wk | 14/871 (1.6) | 20/874 (2.3) | .305 |
| Less than 35 wk | 33/871 (3.8) | 36/874 (4.1) | .727 |
| Less than 37 wk | 73/871 (8.4) | 91/874 (10.4) | .148 |
| Preeclampsia | 74/882 (8.4) | 67/880 (7.6) | .548 |
GA, gestational age.
Data are n/total n (%) or n (mean±standard deviation) unless otherwise specified.
*
Includes fetal demise after randomization, neonatal death before discharge, respiratory distress syndrome, proven sepsis, intraventricular hemorrhage grades III and IV, necrotizing enterocolitis requiring treatment, and congenital abnormalities.
†
Based on Kruskal-Wallis test.