Skip to main content

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