Table 3.

Comparison of fetal or infant outcomes between trial arms

Outcomes	Folic acid group	Placebo group	Relative risk (95% CI)*	P value*
Dichotomised outcomes:
Stillbirth	15 (1.1), n=1364	26 (1.9), n=1374	0.60 (0.30 to 1.19)	0.14
Intrauterine growth restriction <3rd centile	20 (1.4), n=1347	25 (1.9), n=1348	0.76 (0.41 to 1.39)	0.37
Intrauterine growth restriction <10th centile	151 (11.2), n=1347	144 (11), n=1348	1.03 (0.81 to 1.30)	0.82
Neonatal death	8 (0.60), n=1343	11 (0.82), n=1347	0.87 (0.31 to 2.44)	0.79
Perinatal mortality	23 (1.7), n=1364	37 (2.7), n=1374	0.63 (0.37 to 1.05)	0.07
Retinopathy of prematurity	21 (1.6), n=1342	13 (0.97), n=1347	1.20 (0.54 to 2.66)	0.65
Periventricular leukomalacia	4 (0.30), n=1343	2 (0.15), n=1347	2.00 (0.37 to 10.92)	0.42
Early onset sepsis	3 (0.22), n=1342	9 (0.67), n=1347	0.34 (0.09 to 1.23)	0.10
Necrotising enterocolitis	8 (0.60), n=1343	3 (0.22), n=1347	2.04 (0.49 to 8.57)	0.33
Intraventricular haemorrhage	18 (1.3), n=1343	19 (1.4), n=1347	0.97 (0.47 to 2.00)	0.94
Ventilation	49 (3.6), n=1346	30 (2.2), n=1348	1.61 (0.97 to 2.66)	0.06
Need for oxygen at 28 days	9 (0.74), n=1220	3 (0.2), n=1227	2.37 (0.61 to 9.14)	0.21
NICU admission	299 (22), n=1346	267 (20), n=1348	1.08 (0.91 to 1.28)	0.37
Composite severe adverse fetal or neonatal outcome*	63 (4.7), n=1349	51 (3.8), n=1348	1.20 (0.80 to 1.80)	0.38
Continuously distributed outcomes:
NICU length of stay	16 (27)†, n=299	17 (23)†, n=263	−1.60 (−5.84 to 2.64)‡	0.46

NICU=neonatal intensive care unit.

^*Generalised estimating equation was used to account for correlation between two fetuses or infants from the same pregnancy. Composite outcome included any of retinopathy of prematurity, periventricular leukomalacia, early onset sepsis, necrotising enterocolitis, intraventricular haemorrhage, ventilation, need for oxygen at 28 days, and NICU admission.

^†Mean (SD).

^‡Mean difference (95% CI).