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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