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 | Â | Â |
PD<37w. | 10 | 5 | 0.495 | (0.17,1.43) | 0.14 | Â | Â |
Total(denominator)* | 301 | 304 | Â | Â | Â | Â | Â |
*Randomisation errors were not included. | Â | Â | Â | Â | Â | Â | Â |
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 | Â | Â |
PD<37w. | 9 | 3 | 0.326 | (0.09, 1.19) | 0.06 | Â | Â |
Total (denominator)* | 188 | 192 | Â | Â | Â | Â | Â |
* 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 | Â | Â |
PD<37w. | 10 | 5 | 0.500 | (0.17, 1.44) | 0.15 | Â | Â |
Total (denominator)* | 297 | 297 | Â | Â | Â | Â | Â |
*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 | Â | 0.12 | Â | Â |
PD<37w. | 9 | 3 | 0.323 | (0.09, 1.18) | 0.06 | Â | Â |
Total (denominator)* | 241 | 249 | Â | Â | Â | Â | Â |
* 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. |