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Table 3 Outcome Analyses

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

3.1. Premature deliveries related to HPD pregnant women, according to randomization group and adherence
  PLACEBO Treatment  
  Adherent No-adherent Exclusion (ATB) Adherent No-adherent Exclusion(ATB) Total
PD<34w. 0 0 0 1 0 0 1
PD<37w. 0 0 0 2 0 0 2
NPD 11 0 5 9 4 4 33
Total 11 0 5 11 4 4 35
PD: Premature Delivery
NPD:Non-premature delivery
3.2. Relative risk of premature delivery related to NHPD pregnant women - Intent-to-treat analysis *
  Placebo Treatment RR RR 95% CI p**   
PD<34w. 3 1 0.330 (0.03,3.16) 0.31   
PD<37w. 10 5 0.495 (0.17,1.43) 0.14   
Total(denominator)* 301 304      
*Randomisation errors were not included.        
3.3. Relative risk of premature delivery related to NHPD pregnant women - Exploratory analysis
(actual treatment)*
  Placebo Treatment RR RR 95% CI p**   
PD<34w. 3 0 0.000 - 0.12   
PD<37w. 9 3 0.326 (0.09, 1.19) 0.06   
Total (denominator)* 188 192      
* Not included: randomization errors, those who did not receive intervention, post- randomisation exclusions, those who discontinued treatment due to antibiotics prescription, and those who were not adherent.
Additional Analysis (1)
3.4. Relative risk of premature delivery related to NHPD pregnant women
  Placebo Treatment RR RR 95% CI p**   
PD<34w. 3 1 0.333 (0.03, 3.19) 0.31   
PD<37w. 10 5 0.500 (0.17, 1.44) 0.15   
Total (denominator)* 297 297      
*Not included: randomization errors and post-randomisation exclusions
Additional Analysis (2)
3.5. Relative risk of premature delivery related to NHPD pregnant women*
  Placebo Treatment RR RR 95% CI p**   
PD<34w. 3 0 0.000   0.12   
PD<37w. 9 3 0.323 (0.09, 1.18) 0.06   
Total (denominator)* 241 249      
* Not included: randomisation erros, those who did not receive intervention, post-randomisation exclusions, and those who discontinued treatment due to the prescription of antibiotics.
** Fisher's exact test, one tail.