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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