Table 3.
Gestational age at delivery and neonatal outcome in asymptomatic womenwith a singleton pregnancy and sonographic short cervix allocated to receive vaginal progesterone gel (n = 235) compared with those allocated to receive placebo (n = 224): treated patient analysis set
| Outcome | Vaginal progesterone (n (%)) | Placebo (n (%)) | Unadjusted RR (95% CI)* | P* |
|---|---|---|---|---|
| Primary outcome | ||||
| Preterm birth < 33 weeks | 21 (8.9) | 34 (15.2) | 0.59 (0.35–0.98) | 0.040 |
| Secondary outcomes | ||||
| Preterm birth < 28 weeks | 12 (5.1) | 21 (9.4) | 0.54 (0.27–1.08) | 0.077 |
| Preterm birth < 35 weeks | 34 (14.5) | 50 (22.3) | 0.65 (0.44–0.96) | 0.030 |
| Preterm birth < 37 weeks | 71 (30.2) | 74 (33.0) | 0.91 (0.70–1.20) | 0.516 |
| RDS | 7 (3.0) | 16 (7.1) | 0.42 (0.17–0.99) | 0.041 |
| BPD | 4 (1.7) | 5 (2.2) | 0.77 (0.21–2.80) | 0.683 |
| Proven sepsis | 7 (3.0) | 5 (2.2) | 1.33 (0.43–4.14) | 0.617 |
| NEC | 5 (2.1) | 4 (1.8) | 1.19 (0.32–4.38) | 0.792 |
| IVH Grade III/IV | 0 | 1 (0.5) | 0.32 (0.01–7.76)‡ | 0.306 |
| PVL | 0 | 0 | Not estimable | NA |
| Perinatal death | 8 (3.4) | 10 (4.5) | 0.76 (0.31–1.90) | 0.559 |
| Neonatal death | 3 (1.3) | 5 (2.2) | 0.57 (0.14–2.37) | 0.435 |
| Any morbidity/mortality event | 18 (7.7) | 28 (12.5) | 0.61 (0.35–1.08) | 0.085 |
| Birth weight < 2500 g | 60/234 (25.6) | 67/218 (30.7) | 0.83 (0.62–1.12) | 0.229 |
| Birth weight < 1500 g | 15/234 (6.4) | 29/218 (13.3) | 0.48 (0.27–0.87) | 0.014 |
Unadjusted relative risk (RR) and 95% CI calculated using the Cochran–Mantel–Haenszel (CMH) method; P-value based on CMH test.
RR and 95% CI calculated using the CMH method adjusted for pooled study site and risk strata; P value based on CMH test adjusted for pooled study site and risk strata.
Based on Logit estimator with continuity correction. BPD, bronchopulmonary dysplasia; GA, gestational age; IVH, intraventricular hemorrhage; NA, not applicable; NEC, necrotizing enterocolitis; PVL, periventricular leukomalacia; RDS, respiratory distress syndrome.