Table 4.

Gestational age at delivery and neonatal outcome in asymptomatic women with a singleton pregnancy and sonographic short cervix allocated to receive vaginal progesterone gel (n = 194) compared with those allocated to receive placebo (n = 193): compliant analysis set

Outcome	Vaginal progesterone (n (%))	Placebo (n (%))	Unadjusted RR (95% CI)*
Primary outcome
Preterm birth < 33 weeks	21 (8.9)	34 (15.2)	0.59 (0.35–0.98)
Secondary outcomes
Preterm birth < 28 weeks	12 (5.1)	21 (9.4)	0.54 (0.27–1.08)
Preterm birth < 35 weeks	34 (14.5)	50 (22.3)	0.65 (0.44–0.96)
Preterm birth < 37 weeks	71 (30.2)	74 (33.0)	0.91 (0.70–1.20)
RDS	7 (3.0)	16 (7.1)	0.42 (0.17–0.99)
BPD	4 (1.7)	5 (2.2)	0.77 (0.21–2.80)
Proven sepsis	7 (3.0)	5 (2.2)	1.33 (0.43–4.14)
NEC	5 (2.1)	4 (1.8)	1.19 (0.32–4.38)
IVH Grade III/IV	0	1 (0.5)	0.32 (0.01–7.76)‡
PVL	0	0	Not estimable
Perinatal death	8 (3.4)	10 (4.5)	0.76 (0.31–1.90)
Neonatal death	3 (1.3)	5 (2.2)	0.57 (0.14–2.37)
Any morbidity/mortality event	18 (7.7)	28 (12.5)	0.61 (0.35–1.08)
Birth weight < 2500 g	60/234 (25.6)	67/218 (30.7)	0.83 (0.62–1.12)

^*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.