Study group (n = 391) | Control group (n = 391) | p value | |||
---|---|---|---|---|---|
Maternal characteristics of non-inferiority analysis | |||||
Nulliparous (n, %) | 219 | 56.0 | 216 | 55.2 | - |
Mode of birth (n, %) | - | ||||
Spontaneous | 322 | 82.8 | 301 | 77.0 | |
Instrumental vaginal | 39 | 10.0 | 38 | 9.7 | |
Cesarean | 28 | 7.2 | 52 | 13.3 | |
Missing | 2 | 0 | |||
Obstetric injury (n, %) | - | ||||
First degree perineal laceration, labia laceration | 75 | 21.3 | 75 | 22.8 | |
Second degree perineal laceration, vaginal or clitoral laceration | 165 | 46.9 | 168 | 51.1 | |
Third or fourth degree perineal laceration, cervical laceration | 6 | 1.7 | 12 | 3.6 | |
None | 106 | 30.1 | 74 | 22.5 | |
Missing* | 39 | 62 | |||
Adverse outcome in the third stage (n, %) | 30 | 7.7 | 31 | 8.0 | - |
Missing | 2 | 4 | |||
Postpartum hemorrhage (n, %) | 52 | 13.5 | 44 | 11.5 | - |
Missing | 6 | 8 | |||
Further maternal characteristics | |||||
Duration of labor (min), (mean, SD) | 433.6 | 334.9 | 443.9 | 317.0 | 0.663# |
Missing | 6 | 9 | |||
Episiotomy (n, %) | 35 | 9.8 | 31 | 9.3 | 0.888 |
Missinga | 33 | 56 | |||
Epidural anesthesia (n, %) | 89 | 22.9 | 158 | 41.1 | <0.001 |
Missing | 2 | 7 | |||
Hospital discharge within six hours after birth (n, %) | 88 | 23.1 | 27 | 7.0 | <0.001 |
Missing | 10 | 5 | |||
Length of hospital stay (days), admission to discharge (mean, SD) | 2.8 | 1.2 | 3.3 | 1.2 | <0.001 |
Missingb | 104 | 42 | |||
Length of hospital stay (days), birth to discharge (mean, SD) | 2.3 | 1.0 | 2.7 | 1.0 | <0.001 |
Missingb | 105 | 42 | |||
Neonatal characteristics of non-inferiority analysis | |||||
5-minute APGAR score < 7 (n, %) | 2 | 0.5 | 5 | 1.3 | - |
Missing | 1 | 1 | |||
Umbilical cord arterial pH < 7.10 (n, %) | 7 | 1.8 | 9 | 2.3 | - |
Missing | 6 | 4 | |||
Unplanned transfer to specialist neonatal care (n, %) | 10 | 2.6 | 15 | 3.9 | - |
Missing | 6 | 5 | |||
Further neonatal characteristics | |||||
Birthweight (gram), mean (SD) | 3475.2 | 391.3 | 3461.9 | 399.7 | 0.664 |
Missing | 1 | 3 | |||
Birthweight percentile, mean (SD) | 49.7 | 25.5 | 47.1 | 26.7 | 0.173 |
Missing | 91 | 89 | |||
1-minute APGAR score (mean, SD) | 8.9 | 0.7 | 8.8 | 1.0 | 0.305 |
Missing | 1 | 2 | |||
5-minute APGAR score (mean, SD) | 9.8 | 0.6 | 9.7 | 0.8 | 0.855 |
Missing | 1 | 1 | |||
10-minute APGAR score (mean, SD) | 10.0 | 0.2 | 9.9 | 0.3 | 0.035 |
Missing | 1 | 1 | |||
Umbilical cord arterial pH (mean, SD) | 7.3 | 0.1 | 7.3 | 0.1 | 0.080 |
Missing | 6 | 4 | |||
Umbilical cord arterial Base Excess (mean, SD) | -5.6 | 3.4 | -5.4 | 3.4 | 0.163 |
Missing | 10 | 9 |