Table 1

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

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.

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

Open Data