Table 3

Outcome Analyses

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.


Krauss-Silva et al. Trials 2011 12:239   doi:10.1186/1745-6215-12-239

Open Data