Table 1 Post-randomization distribution of relevant risk variables according to treatment group for the stratum of women without history of premature delivery (NHPD)

From: A randomised controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with bacterial vaginosis: preliminary results

	Placebo			Treatment			Total
Factor	Frequency	%	Mean	Frequency	%	Mean	Frequency	%	Mean
Gestacional Age at
Randomization
< 12w	9	3.0%	11w.2d	4	1.3%	11w.4d	13	2.1%	11w.2d
(12w-16w)	103	34.1%	14w.2d	115	37.5%	14w.3d	218	35.8%	14w.2d
(16w-20w)	190	62.8%	18w.6d	186	61.2%	18w.3d	376	61.70%	18w.5d
>20w*	2	0.7%	21w.3d	0	0.0%	-	2	0.3%	21w.3d
Total	304	100.0%	17w.1d	305	100.0%	16w.6d	609	100.0%	16w.7d
Nugent Score
<4	2	0.7%	2.5	1	0.3%	1.0	3	0.5%	2.0
4-6	81	26.6%	5.4	90	29.5%	5.4	171	28.1%	5.4
7-8	181	59.5%	7.6	173	56.7%	7.6	354	58.5%	7.6
9-10	40	13.2%	9.2	41	13.4%	9.4	81	13.3%	9.3
Total	304	100.0%	7.2	305	100.0%	7.2	609	100.0%	7.2
Lag between elegible
Nugent score and
randomization
< = 2 weeks	180	59.2%	1w.3d	184	60.3%	1w.1d	364	59.8%	1w.2d
>2 weeks	124	40.8%	3w.1d	121	39.7%	3w.3d	245	40.2%	3w.2d
Total	304	100.0%	2w.1d	305	100.0%	2w.0d	609	100.0%	2w.0d
pH
4.5	90	29.6%	4.50	81	26.6%	4.50	171	28.1%	4.50
5.0	151	49.7%	5.00	156	51.1%	5.00	307	50.4%	5.00
5.5 or 6.0	63	20.7%	5.52	68	22.3%	5.54	131	21.5%	5.53
Total	304	100.0%	4.96	305	100.0%	4.99	609	100.0%	4.97
Age (years)
<18	41	13.5%	16.4	39	12.8%	16.4	80	13.1%	16.4
> = 18	263	86.5%	24.8	266	87.2%	24.6	529	86.9%	24.7
Total	304	100.0%	23.7	305	100.0%	23.6	609	100.0%	23.6
Height (m)
< = 1.55	83	27.3%	1.52	72	23.6%	1.52	155	25.5%	1.52
>1.55	221	72.7%	1.63	233	76.4%1	1.63	454	74.5%	1.63
Total	304	100.0%	1.60	305	100.0%	1.60	609	100.0%	1.60
Ethnicity
White	105	34.5%		103	33.8%		208	34.2%
Black	199	65.5%		200	65.6%		399	65.5%
NA	0	0%		2	0.7%		2	0.3%
Total	304	100.0%		305	100.0%		609	100.0%
Nulliparity
No	109	35.9%		115	37.7%		224	36.8%
Yes	195	64.1%		190	62.3%		385	63.2%
Total	304	100.0%		305	100.0%		609	100.0%
Adherence
No	107	35.2%		104	34.1%		211	34.6%
Yes	197	64.8%		201	65.9%		398	65.4%
Total	304	100.0%		305	100.0%		609	100.0%

*Randomization errors: one error was related to the determination of gestational age and 3 errors were related to the assessment of the Nugent score.

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ISSN: 1745-6215

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