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Table 1 Mean changes from baseline in bishop score in the all treated and per protocol (PP) populations

From: Recombinant human relaxin versus placebo for cervical ripening: a double-blind randomised trial in pregnant women scheduled for induction of labour

  Mean ± SD
Active (μg/kg/day)
Part A Part B Pooled MTDa Pooled Placeboa
7.5 25 75 75 75 Placebo
All Treated population
 N 7 4 4 25 29 32
 Baseline 2.6 ± 1.6 2.5 ± 1.9 2.5 ± 1.9 2.2 ± 1.2 2.2 ± 1.3 1.9 ± 1.6
 Change from Baseline:
  6 h 1.29 ± 0.95 1.25 ± 0.96 1.50 ± 1.91 1.56 ± 2.20 1.55 ± 2.13 1.77 ± 1.45
  12 h 2.43 ± 1.13 2.25 ± 1.71 2.00 ± 1.63 2.13 ± 2.11 2.11 ± 2.02 2.64 ± 1.64
  24 h 3.20 ± 0.84 3.00 ± 4.24 2.50 ± 1.91 3.42 ± 2.34 3.26 ± 2.26 4.19 ± 1.90
  Last observationb 3.43 ± 0.79 2.75 ± 2.50 2.50 ± 1.91 3.76 ± 2.57 3.59 ± 2.50 4.03 ± 1.90
PP population
 N 5 2 4 19 23 26
 Baseline 3.0 ± 1.7 2.0 ± 2.8 2.5 ± 1.9 2.0 ± 1.2 2.1 ± 1.3 1.6 ± 1.6
 Change from Baseline:
  6 h 1.00 ± 0.71 1.00 ± 1.41 1.50 ± 1.91 0.84 ± 1.21 0.96 ± 1.33 1.65 ± 1.38
  12 h c 1.80 ± 0.45 2.00 ± 2.83 2.00 ± 1.63 1.63 ± 1.67 1.70 ± 1.64 2.62 ± 1.60
  24 h 3.20 ± 0.84 3.00 ± 4.24 2.50 ± 1.91 3.42 ± 2.34 3.26 ± 2.26 4.19 ± 1.90
  Last observationb 3.20 ± 0.84 3.00 ± 4.24 2.50 ± 1.91 3.42 ± 2.34 3.26 ± 2.26 4.19 ± 1.90
  1. The Bishop score ranges from 0 (absence of any cervical changes) to a maximum of 13, representing a cervix that is dilated (>5 cm), effaced (>80 %), soft, at a +1 or +2 station, and anteriorly positioned. 26 If the total Bishop score was calculated >13, then ‘13’ was used. Change was calculated as Bishop score at time point – Bishop score at baseline. All Treated population includes all patients treated with any amount of study drug. Per protocol (PP) population includes all patients treated for at least 18 h of study drug
  2. aPooled Maximum Tolerated Dose (MTD) group includes subjects who were administered the 75 μg/kg/day dose in Parts A and B of the study. Pooled placebo group includes all subjects who received placebo in Parts A and B
  3. bLast observation was defined as the last available value observed during dosing
  4. cDifference between the pooled MTD and pooled placebo groups at 12 h, p = 0.042 by Wilcoxon Rank Sum test. No other differences were significant