Skip to main content

Table 1 Analysis between randomized and non-randomized VAD

From: Perinatal outcome after vacuum assisted delivery with digital feedback on traction force; a randomised controlled study

 

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

  1. VAD vacuum assisted delivery, ICH intracranial hemorrhage, HIE hypoxic ischemic encephalopathy, BMI body mass index, OFHR ominous fetal heart rate, OAP occipital-anterior position. mean±sd¹, IQR (Q3-Q1)2, *clavicle, skull, humerus