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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