Primary endpoint |
|
|
|
|
Vaizey score at M6, median [IQR]
|
1.0 [0.0-3.0]
|
1.0 [0.0-4.0]
|
0.0 (0.0 to 2.0)
|
0.34
|
Secondary endpoints |
|
|
|
|
Vaizey score at W6-8, median [IQR]
|
0.0 [0.0-3.0]
|
0.0 [0.0-3.0]
|
0.0 (-2.0 to 1.0)
|
|
Post-partum transient anal incontinence at W6-8, no. (%)
|
18 (25.0)
|
9 (11.7)
|
-13.3 (-25.1 to 0.0)
|
|
MUH score at M6, median [IQR] |
0.0 [0.0-4.0] |
1.0
[0.0-4.0] |
1.0 (-1.0 to 2.0) |
|
FSFI score at M6, median [IQR]
|
28.1 [23.5-31.2]
|
27.1 [22.1-31.4]
|
-1.0 (-4.0 to 1.9)
|
|
Physical SF12 score at M6, mean ± SD
|
52.1 (6.7)
|
51.7 (7.0)
|
-0.4 (-2.5 to 1.6)
|
|
Mental SF12 score at M6, mean ± SD |
46.2 (9.2) |
46.6 (9.5) |
0.4 (-2.3
to 3.2) |
|
Maternal morbidities, no. (%)
|
4 (4.9)
|
8 (8.8)
|
3.9 (-2.7 to 11.2)
|
|
Neonatal morbidities, no. (%)
|
5 (6.1)
|
0 (0.0)
|
-6.1 (-11.7 to -1.3)
|
|
Worsening of external sphincter lesions at ultrasound, no. (%)
|
11 (22.4)
|
1 (2.2)
|
-20.2 (-31.7 to -7.6)
|
|