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Table 6 Comparison of summary statistics between trial phases and intervention allocation

From: Using electronic patient records to assess the effect of a complex antenatal intervention in a cluster randomised controlled trial—data management experience from the DESiGN Trial team

  Pre-randomisation phase Trial comparison phase
Control sites Intervention sites Control sites Intervention sites
Observed data Imputed dataset Observed data Imputed dataset Observed data Imputed dataset Observed data Imputed dataset
Maternal height (median [IQR]) 1.64 [1.60, 1.68] 1.64 [1.60, 1.69] 1.63 [1.58, 1.68] 1.63 [1.58, 1.68] 1.64 [1.60, 1.69] 1.64 [1.60, 1.69] 1.64 [1.60, 1.69] 1.63 [1.59, 1.68]
Maternal weight (median [IQR]) 66.0 [58.8, 76.0] 66.0 [58.5, 76.0] 64.5 [57.0, 74.0] 64.7 [57.3, 74.4] 67.2 [59.9, 78.0] 67.0 [59.5, 77.9] 67.2 [59.9, 78.0] 65.4 [58.0, 76.0]
Ethnicitya:
 White (%) 62.4% 62.8% 46.9% 50.2% 62.4% 62.7% 50.2% 50.6%
 Black (%) 16.6% 16.2% 12.4% 11.8% 15.4% 15.1% 10.8% 10.9%
 Asian (%) 13.4% 13.3% 27.1% 24.8% 13.5% 13.5% 25.2% 24.6%
 Mixed (%) 2.2% 2.1% 1.6% 1.6% 2.6% 2.6% 1.3% 1.3%
 Other (%) 5.4% 5.5% 12.1% 11.6% 6.1% 6.1% 12.5% 12.6%
Parity (% multiparous) 49.4% 53.7% 46.8% 46.5% 48.8% 52.5% 48.8% 51.6%
Neonatal birthweight in grams (median [IQR]) 3380 [3050, 3700] 3380 [3050, 3700] 3340 [3010, 3660] 3340 [3010, 3660] 3360 [3040, 3670] 3360 [3035, 3670] 3320 [3000, 3645] 3320 [2996, 3645]
Neonatal gestational age at birth in weeks (median [IQR]) 40 [39, 41] 40 [39, 41] 40 [39, 41] 40 [39, 41] 40 [39, 41] 40 [39, 41] 40 [39, 41] 40 [39, 41]
  1. aFive categories of ethnicity presented here for brevity, but ethnicity imputed according to categories used by the foetal/neonatal weight customised centile calculator, e.g. British European, Central African, Chinese, Mixed Asian-European