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Table 5 Secondary criteria and adverse events

From: Clinical impact of the disposable ventouse iCup® versus a metallic vacuum cup: a multicenter randomized controlled trial

 

Disposable cup group (n = 295)

Metallic cup group (n = 283)

p-value

Maternal outcomes

   

 Postpartum hemorrhage > 500 ml

31 (10.5 %)

25 (8.8 %)

NS

 Postpartum hemorrhage > 1000 ml

0 (0.0 %)

0 (0.0 %)

NS

 Other maternal adverse eventa

18 (6.1 %)

19 (6.7)

NS

Neonatal outcomes

   

 Apgar score <7

   

  1 minute (294)

38 (13.9 %)

32 (11.3 %)

NS

  5 minutes (294)

7 (2.4 %)

6 (2.1 %)

NS

  10 minutes (293)

3 (1.0 %)

0 (0.0 %)

NS

 Umbilical arterial pH

(n = 277)

(n = 262)

 

 pHa < 7.0

5 (1.8 %)

3 (1.1 %)

NS

 pHa < 7.20

99 (35.7 %)

89 (34.0 %)

NS

 Umbilical venous pH

(n = 191)

(n = 185)

 

 pHv < 7.0

0 (0.0 %)

1 (0.5 %)

NS

 pHv < 7.20

28 (14.7 %)

20 (10.8 %)

NS

 Minor scalp injuries

11 (3.7 %)

14 (5.0 %)

NS

 Transfer to Resuscitation unit

25 (8.5 %)

22 (7.8 %)

NS

 Anaemiab

4 (1.4 %)

2 (0.7 %)

NS

 Jaundiceb

45 (15.3 %)

51 (18.0 %)

NS

 other neonatal adverse eventa

33 (11.2 %)

27 (9.5 %)

NS

 Serious adverse eventc

3 (11.2 %)

0 (0 %)

NS

  1. aProlongation of hospitalization or unit transfer
  2. bEvent observed at D1 and D3
  3. cOne maternal and 2 neonatal events reported by the hospital vigilance unit: one postpartum hemorrhage, one minor scalp injury, and one neonatal intracerebral hemorrhage