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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