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Table 3 Primary composite criterion and analysis of its separate elements

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

Primary composite criteriona

225 (76.3 %)

196 (69.3 %)

0.06

Failed delivery with allocated vacuum deviceb

105 (35.6 %)

20 (7.1 %)

0.0001

 Forceps whatever the number of detachments

29 (9.8 %)

14 (5.0 %)

0.03

 Caesarean section whatever the number of detachments

13 (4.4 %)

3 (1.1 %)

0.01

 Other type of vacuum cup whatever the number of detachments

71 (24.1 %)

3 (1.1 %)

<0.01

3 detachmentsc

9 (3.1 %)

1 (0.4 %)

0.02

Neonatal outcomes

   

 Caput succedaneum

62 (21.0 %)

63 (22.3 %)

NS

 Cephalohaematoma

5 (1.7 %)

4 (1.4 %)

NS

Maternal outcomes

   

 Episiotomy

116 (39.3 %)

108 (38.1 %)

NS

 No perineal tears

22 (7.5 %)

7 (2.5 %)

<0.01

 First degree perineal tear(s) only

103 (34.9 %)

101 (35.7 %)

NS

 Second degree perineal tear(s) only

50 (17.0 %)

58 (20.5 %)

NS

 Third degree/fourth degree perineal tearsd

5 (1.7 %)

14 (5.0 %)

<0.01

  1. aAt least one event
  2. bNine mothers had at least two attempted modes of delivery (2 F + CS, 1 F+ other cup and 6 CS+ other cup)
  3. cEutocic delivery after 3 detachments
  4. dPerineal tears potentially associated with episiotomy (six mothers: 1 in the disposable cup group and 5 in the metallic cup group)