Non randomised (n = 422) n (%) | Randomised (n = 663) n (%) | p-value | |
---|---|---|---|
Primary outcome (HIE, ICH, seizure, death, subgaleal hematoma) | 13 (3%) | 16 (2.4%) | 0.56 |
Maternal characteristics | |||
Age1 | 31±5 | 31±5 | 0.68 |
BMI (kg/m2)1 | 23±4 | 24±4 | 0.47 |
Missing | 20 (5%) | 26 (4%) | |
Nulliparous | 312 (74%) | 521 (79%) | 0.09 |
Gest. length, days¹ | 283±8 | 283±8 | 0.74 |
Characteristics: delivery and vacuum extraction | |||
Time cx 3 cm – fully dilated, hours¹ | 8±5 | 9±5 | 0.50 |
Time fully dilated to vacuum extraction, hours¹ | 2±1.5 | 3±1.5 | 0.30 |
Indication | |||
- OFHR | 198 (47%) | 207 (31%) | <0.001 |
Station | |||
- Mid | 189 (45%) | 306 (46%) | 0.66 |
- Low | 135 (32%) | 261 (39%) | <0.05 |
- Outlet | 78 (18%) | 96 (14%) | 0.09 |
Number of pulls, n2 | 2 (4-2) | 2 (4-2) | 0.61 |
Missing | 14 (3%) | 15 (2%) | |
Vacuum extraction duration, min2 | 5.3 (8.3-3.0) | 4.0 (8.0-4.0) | 0.73 |
Position OAP | 369 (87%) | 596 (90%) | 0.23 |
Failed vacuum extraction | 33 (8%) | 56 (8%) | 0.74 |
Pop-off | 27 (6%) | 51 (8%) | 0.47 |
Pop-off ≥2 | 7 (2%) | 9 (1%) | 0.79 |
Perinatal characteristics | |||
Birth weight, g¹ | 3540±489 | 3558±464 | 0.40 |
NICU | 41 (10%) | 61 (9%) | 0.83 |
Gender | 0.74 | ||
- Male | 242 (57%) | 386 (58%) | |
- Female | 180 (43%) | 277 (42%) | |
pH<7.00 | 7 (2%) | 11 (2%) | 1 |
Missing | 64 (15%) | 65 (10%) | |
pH<7.10 | 54 (13%) | 84 (13%) | 0.70 |
Missing | 64 (15%) | 65 (10%) | |
APGAR<7 at 5 min | 15 (4%) | 19 (3%) | 0.59 |
Fracture* | 5 (1%) | 6 (1%) | 0.76 |
Plexus injury | 4 (1%) | 5 (0.8%) | 0.74 |