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Table 3 Secondary efficacy endpoints in the all treated population

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

  Pooled MTDa
(n = 29)
Pooled Placeboa
(n = 32)
p value
Proportion of Subjects with 24 h Change from Baseline in Bishop Score >3b 13/23 (56.5 %) 18/26 (69.2 %) 0.36
Incidence of Spontaneous Labourd 12 / 29 (41.4 %) 20 / 32 (62.5 %) 0.12
Incidence of Vaginal Deliveriesd 20 / 29 (69.0 %) 27 / 32 (84.4 %) 0.15
Time to Vaginal Delivery, Mean ± SDc 62.3 ± 40.2 h 54.3 ± 29.3 h 0.64
Time to Delivery (Vaginal + C-section), Mean ± SDc 66.8 ± 39.6 h 54.5 ± 30.1 h 0.25
Time to Complete Dilation (10 cm), Mean ± SDc 57.5 ± 39.5 h 52.7 ± 26.2 h 1.00
Time to Onset of Active Laboure, Mean ± SDc 53.2 ± 36.3 h 45.8 ± 29.9 h 0.41
  1. 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
  2. bSubjects included have Bishop scores available at both baseline and 24 h
  3. cp value was calculated using the Wilcoxon Rank-sum test
  4. dp value was calculated using the Chi-square test
  5. eActive labour was defined as having 35–45 s contractions every 3 min with 4 cm dilation