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

Table 3 Secondary efficacy endpoints in the all treated population

	Pooled MTD^a (n = 29)	Pooled Placebo^a (n = 32)	p value
Proportion of Subjects with 24 h Change from Baseline in Bishop Score >3^b	13/23 (56.5 %)	18/26 (69.2 %)	0.36
Incidence of Spontaneous Labour^d	12 / 29 (41.4 %)	20 / 32 (62.5 %)	0.12
Incidence of Vaginal Deliveries^d	20 / 29 (69.0 %)	27 / 32 (84.4 %)	0.15
Time to Vaginal Delivery, Mean ± SD^c	62.3 ± 40.2 h	54.3 ± 29.3 h	0.64
Time to Delivery (Vaginal + C-section), Mean ± SD^c	66.8 ± 39.6 h	54.5 ± 30.1 h	0.25
Time to Complete Dilation (10 cm), Mean ± SD^c	57.5 ± 39.5 h	52.7 ± 26.2 h	1.00
Time to Onset of Active Labour^e, Mean ± SD^c	53.2 ± 36.3 h	45.8 ± 29.9 h	0.41

^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
^bSubjects included have Bishop scores available at both baseline and 24 h
^cp value was calculated using the Wilcoxon Rank-sum test
^dp value was calculated using the Chi-square test
^eActive labour was defined as having 35–45 s contractions every 3 min with 4 cm dilation

ISSN: 1471-2393