Table 2.
Feasibility of delivery with the Odon device in 49 women enrolled in the Odon device pilot study: All women and by parity
| 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 |
aOne case was interpreted as anterior position at obstetrical examination but at delivery was occiput posterior position
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
cPlastic sleeve detached at the moment of crowning
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