Table 3. Neonatal Outcomes Among Live Births.
| Outcomes | Pessary (n = 279) | Usual care (n = 263) | Absolute median difference (95% CI) | Unadjusted relative risk (95% CI) |
|---|---|---|---|---|
| Fetal or neonatal/infant death, No. (%) | 37 (13.3) | 18 (6.8) | 1.94 (1.13-3.32) | |
| Live births | n = 261 | n = 254 | ||
| Ventilator or continuous positive airway pressure use, No./total (%) | 75/259 (29.0) | 82/254 (32.3) | 0.90 (0.69-1.17) | |
| Ventilator or continuous positive airway pressure, median (IQR), d | 6 (0-43) [n = 97] | 5 (0-41) [n = 104] | 0 (−12 to 12) | |
| Supplemental oxygen, median (IQR), d | 7 (0-41) [n = 95] | 6 (0-51) [n = 105] | 1 (−12 to 14) | |
| Seizures requiring treatment, No./total (%) | 1/259 (0.4) | 1/254 (0.4) | 0.98 (0.06-15.7) | |
| Small for gestational age (less than fifth percentile), No./total (%) | 5/256 (1.9) | 6/257 (2.4) | 0.82 (0.25-2.65) | |
| Intraventricular hemorrhage grade 3 or 4, No./total (%) | 4/258 (1.6) | 7/254 (2.8) | 0.56 (0.17-1.90) | |
| Retinopathy of prematurity, No./total (%) | 27/259 (10.4) | 23/254 (9.1) | 1.15 (0.68-1.96) | |
| Respiratory distress syndrome, No./total (%) | 67/259 (25.9) | 69/254 (27.2) | 0.95 (0.71-1.27) | |
| Bronchopulmonary dysplasia, No./total (%) | 14/260 (5.4) | 19/254 (7.5) | 0.72 (0.37-1.41) | |
| Necrotizing enterocolitis stage 2 or 3, No./total (%) | 7/259 (2.7) | 6/254 (2.4) | 1.14 (0.39-3.37) | |
| Hyperbilirubinemia, No./total (%)a | 84/259 (32.4) | 82/253 (32.4) | 1.00 (0.78-1.29) | |
| Neonatal infectious morbidity, No./total (%) | 53/259 (20.5) | 65/254 (25.6) | 0.80 (0.58-1.10) | |
| Suspected sepsis | 38 (14.7) | 51 (20.1) | 0.67 (0.47-0.97) | |
| Early-onset sepsisb | 5 (1.9) | 2 (0.8) | 2.45 (0.48-12.57) | |
| Late-onset sepsisb | 8 (3.1) | 12 (4.7) | 0.65 (0.27-1.58) | |
| Pneumonia | 2 (0.8) | 4 (1.6) | 0.49 (0.09-2.66) | |
| Composite neonatal outcome, No./total (%)c | 81/260 (31.2) | 74/254 (29.1) | 1.05 (0.81-1.37) | |
| Hospital length of stay, median (IQR), d | 3 (2-20) [n = 258] | 3 (2-22) [n = 253] | 0 (0 to 0) | |
| Special care admission, No./total (%) | 98/260 (37.7) | 105/254 (41.3) | 0.91 (0.74-1.13) | |
| Special care length of stay, median (IQR), d | 50 (10-99) [n = 97] | 37 (11-88) [n = 104] | 10 (−16 to 36) | |
| Birth weight, median (IQR), g | 2847 (1410-3300) [n = 258] | 2810 (1690-3290) [n = 253] | 35 (−194 to 264) | |
| Congenital malformation, No./total (%) | 4/259 (1.5) | 2/253 (0.8) | 1.95 (0.36-10.61) |
a
Peak total bilirubin of 15 mg/dL or higher or phototherapy use.
b
Early-onset sepsis defined as diagnosis at or prior to 72 hours postbirth. Late-onset sepsis defined as diagnosis after 72 hours postbirth.
c
Includes any of death, respiratory distress syndrome, intraventricular hemorrhage grade 3 or 4, periventricular leukomalacia, necrotizing enterocolitis stage 2 or 3, bronchopulmonary dysplasia, retinopathy of prematurity stage 2 or higher, or early-onset sepsis.