Table 4.

Treatment effects on birth outcomes (Geometric means and 95 % confidence intervals; median and interquartile range (IQR); mean values and 95 % confidence intervals; relative rates (RR) and 95 % confidence intervals)

	HN001		Placebo
	Geometric mean	95 % CI	Geometric mean	95 % CI	Geometric mean ratio	95 % CI	P
Maternal weight post birth (kg)*	n 197		n 194
	76·7	76·1, 77·2	76·8	76·2, 77·4	1·00	0·99, 1·01	0·79
Maternal waist post birth (cm)*	n 195		n 195
	97·7	96·8, 98·7	97·3	96·4, 98·2	1·00	0·99, 1·02	0·53
Maternal BMI post birth (kg/m2)*	n 197		n 194
	28·0	27·8, 28·2	28·1	27·9, 28·3	1·00	0·99, 1·01	0·69
Number of weeks of gestation	n 205		n 201		Difference in median
Median	39·7		39·6		0·1	−0·1, 0·4	0·31†
IQR	38·7, 40·7		38·7, 40·4
	Mean	95 % CI	Mean	95 % CI	Differences in means	95 % CI
Birth weight of child (kg)	n 205		n 202
	3·6	3·5, 3·7	3·5	3·4, 3·6	0·1	−0·1, 0·2	0·36
Birth length of child (cm)	n 205		n 199
	51·3	51·0, 51·7	51·2	50·8, 51·5	0·2	−0·3, 0·7	0·48
Ponderal index of child	n 204		n 199
	25·9	25·5, 26·2	25·7	25·4, 26·1	0·1	−0·4, 0·7	0·59
Head circumference of child (cm)	n 205		n 201
	35·3	35·1, 35·6	35·4	35·2, 35·6	−0·1	−0·4, 0·2	0·67
	%	n	%	n	RR	95 % CI
Macrosomia (≥4000 g)	22·4	46/205	15·8	32/202	1·41	0·94, 2·12	0·10
Premature (<37 weeks’ gestation)	7·8	16/205	4·0	8/201	1·96	0·86, 4·48	0·10
Caesarean delivery	27·7	57/206	25·4	51/201	1·09	0·79, 1·51	0·60
Admission to NICU	11·3	23/203	11·0	22/201	1·04	0·60, 1·80	0·90
Apgar score ≥7 at 5 min	98·5	200/203	98·0	198/202	1·51‡	1·01, 2·27	0·04

HN001, Lactobacillus rhamnosus HN001; NICU, Neonatal Intensive Care Unit.

^*ANCOVA on logged values, adjusted for logged baseline measures, geometric means are fitted for the baseline geometric mean.

^†Wilcoxon’s rank-sum test.

^‡OR of having a higher Apgar score; Apgar scores grouped 0–3, 4–6, 7, 8, 9, 10: ordinal logistic regression.