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Table 1 Stillbirth rates during the pretrial (2010) and trial periods by ACT intervention group and site

From: The global network antenatal corticosteroids trial: impact on stillbirth

Pretrial period

 

Argentina

Guatemala

Pakistan

Belgaum

Nagpur

Kenya

Zambia

Total

Characteristica

Int

Cntl

Int

Cntl

Int

Cntl

Int

Cntl

Int

Cntl

Int

Cntl

Int

Cntl

Int

Cntl

RR (95 %)b

p-value

All babies, N

1,439

1,437

2,981

2,321

5,481

7,101

8,675

9,649

5,206

4,958

3,994

5,209

2,986

4,188

30,762

34,863

  

Stillbirths, N (Rate/1000)a

28 (19.5)

22 (15.3)

67 (22.5)

50 (21.5)

295 (53.8)

320 (45.1)

255 (29.4)

252 (26.1)

148 (28.4)

126 (25.4)

84 (21.0)

102 (19.6)

101 (33.8)

90 (21.5)

978 (31.8)

962 (27.6)

1.17 (1.06,1.29)

0.003

<5th percentile for weight babies, N

81

99

124

123

717

746

358

389

267

299

167

217

176

214

1,890

2,087

  

<5th percentile stillbirths, N (Rate/1000)a

16 (197.5)

12 (121.2)

27 (217.7)

18 (146.3)

214 (298.5)

200 (268.1)

150 (419.0)

154 (395.9)

90 (337.1)

87 (291.0)

36 (215.6)

39 (179.7)

54 (306.8)

59 (275.7)

587 (310.6)

569 (272.6)

1.15 (1.04, 1.28)

0.008

Trial period

 

Argentina

Guatemala

Pakistan

Belgaum

Nagpur

Kenya

Zambia

Total

Characteristica

Int

Cntl

Int

Cntl

Int

Cntl

Int

Cntl

Int

Cntl

Int

Cntl

Int

Cntl

Int

Cntl

RR (95 %)b

p-value

All babies, N

2,122

2,311

5,863

3,978

7,800

8,315

15,022

16,774

7,570

7,655

5,993

7,187

4,328

5,787

48,698

52,007

  

Stillbirths, N (Rate/1000)a

25 (11.8)

31 (13.4)

113 (19.3)

73 (18.4)

388 (49.7)

351 (42.2)

376 (25.0)

382 (22.8)

158 (20.9)

181 (23.6)

145 (24.2)

154 (21.4)

99 (22.9)

92 (15.9)

1,304 (26.8)

1,264 (24.3)

1.11 (1.02–1.22)

0.018

Adjusted for pretrial SB rate

1.08 (0.99,1.17)

0.073

<5th percentile for weight babies, N

105

149

390

192

984

890

777

874

464

377

288

252

260

263

3,268

2,997

  

<5th percentile stillbirths, N (Rate/1000)a

14 (133.3)

18 (120.8)

44 (112.8)

26 (135.4)

224 (227.6)

203 (228.1)

244 (314.0)

256 (292.9)

107 (230.6)

122 (323.6)

53 (184.0)

63 (250.0)

62 (238.5)

51 (193.9)

748 (228.9)

739 (246.6)

0.99 (0.90–1.09)

0.813

Adjusted for pretrial <5th percentile for weight SB rate

0.97 (0.89, 1.05)

0.409

  1. aThe trial period included births between October 2011 and March 2014, depending on each site’s 18-month enrollment period, with most births occurring in 2012 and 2013. Most births included in the pretrial period occurred in 2010. However, for the four clusters in Belgaum, India which were added after 2010, births from May 2011-May 2012 were included. Stillbirths are ≥ 20 weeks gestational age or ≥ 500 g. The denominator for the stillbirth rate is stillbirths + live births
  2. bGeneralized linear models were used to evaluate the relationship between covariates and the outcomes of interest and to develop point and interval estimates of relative risk (RR) associated with these risk factors. Generalized estimating equations were used to account for the correlation of outcomes within cluster to develop appropriate confidence intervals. Models were log binomial when possible, otherwise Poisson models were utilized. Models were adjusted for randomization strata