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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