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Table 3 Maternal and neonatal outcomes during delivery and immediate postpartum (24-48 h) of 49 women enrolled in the Odon device pilot study: All women and by parity

From: Odon device for instrumental vaginal deliveries: results of a medical device pilot clinical study

Indicators

Multiparous

Nulliparous

Total

N = 36

N = 13

N = 49

Mean (range) or n (%)

Mean (range) or n (%)

Mean (range) or n (%)

Maternal outcomes

  

 Any vaginal or perineal tearsa

18 (50%)

11 (85%)

29 (59%)

 Any vaginal or perineal tearsa and/or episiotomy

23 (64%)

12 (92%)

35 (71%)

  Vulvar tears

2 (5%)

0

2 (4%)

  Vaginal lower half tears

9 (25%)

11 (85%)

20 (40%)

  Vaginal upper half tears

0

0

0

  Perineal 1st degree tear

8 (22%)

1 (8%)

9 (19%)

  Perineal 2nd degree tears

1 (3%)

1 (8%)

2 (4%)

  Perineal 3rd/4th degree tears

0

0

0

  Episiotomy

7 (19%)

2 (15%)

9 (18%)

 Cervical tearsb

2 (5%)

2 (15%)

4 (8%)

 Postpartum infection

1(3%)

1(8%)

2 (4%)

Infant outcomes

 Male

21 (58%)

9 (69%)

30 (61%)

 Mean gestational age (weeks)

39.8 (37 - 41)

40.0 (38 - 41)

39.6 (37.0- 40.0)

 Mean birth weight (grams)

3654 (2780 - 4560)

3488 (2880 - 4090)

3610 (2780 - 4560)

 Apgar score at 5 min ≥ 7

36

13

49 (100%)

 Caput succedaneum and moulding

3 (8%)

5 (38%)

8 (16%)

 Cephalhematomac

0

1 (8%)

1 (2%)

 Admission to neonatal intensive care unit

1 (3%)

1 (8%)

2 (4%)

  1. aWomen may have more than one type of vaginal or perineal, excluding cervical tears
  2. bThirty-women had at least one type of vaginal, perineal or cervical tears
  3. cOne moderate