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Table 2 Feasibility of delivery with the Odon device in 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 or n (%)

Mean or n (%)

Mean or n (%)

Device application

 Fetal Station

  Station + 2/Hodge’s 3rd

22 (61%)

10 (77%)

32(65%)

  Station + 3/Hodge’s 4th

14 (39%)

3 (23%)

17 (35%)

 Vertex variety of positiona

  Occiput anterior

26 (72%)

10* (77%)

36 (73%)

  Left or right occiput anterior

10 (28%)

3 (13%)

13 (27%)

 Mean time of insertion (minutes:seconds)

01:39

00:50

01:27

Successful application of the Odon device

  Yesb

26 (72%)

9 (69%)

35 (71%)

  No

10 (28%)

4 (31%)

14 (29%)

   Spontaneous delivery, failed insertion

2

1

3

   Spontaneous delivery, fetal descent with Odon

2

0

2

   Spontaneous delivery, crowning with Odonc

4

2

6

   Forceps

2

1

3

Reasons of non-successful delivery with Odon device

 Device was difficult to place

2

1

3

 Device broke off

1

1

2

 Device slipped off, air leaksd

5

1

6

 Device slipped off, no apparent cause

2

1

3

  1. aOne case was interpreted as anterior position at obstetrical examination but at delivery was occiput posterior position
  2. bSuccessful application of the device was defined as: (1) reaching number 4 or 5 in the reading window of the inserter, (2) successful inflation of the device without leaks after the expulsion, and (3) successful expulsion of the fetal head with the plastic sleeve around the fetal head after one-time application of the Odon device
  3. cPlastic sleeve detached at the moment of crowning
  4. dFive cases were caused by air leaks in the air cuffs, as documented by post-application examination of the cuffs, and one was caused by an air leak in the bulb pump
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Reproductive Health

ISSN: 1742-4755