New instrument for assisted vaginal delivery
Last Updated: January 2018
Safety and feasibility study
Complications due to prolonged second stage of labour include potentially fatal maternal (haemorrhage, infection) and newborn complications (birth asphyxia and trauma)
The Odon device is an innovation, presently under development, intended to assist vaginal birth when second stage takes longer than what is considered safe or if complications arose (e.g. baby is large or distressed). The device was invented by Mr Jorge Odón from Argentina. BD (Becton Dickinson and Company) acquired the license of the device in 2013 and developed of a new prototype
HRP supported research to evaluate whether this new device helps pushing out of the baby through the birth canal. The study included women at their first delivery and women who delivered before, with uncomplicated pregnancies and one fetus in two hospitals in Argentina and South Africa. Delivery with the Odon device was attempted in women without complications in the late stage of labour. The Odon device was inserted successfully in 46 of the 49 women included (93%), and successful delivery with expulsion of the fetal head after one-time application of the Odon device was achieved in 35 (71%) women. Some form of trauma to the genital tract (vaginal or perineum) occurred in 29 (59%) women. This could be considered an average frequency of genital tears. However, as the use in humans has been limited, increased risk of tears and other unknown risks cannot be ruled out. All babies were born alive and vigorous. No adverse maternal or infant outcomes were observed at 6-weeks follow-up, and at one year for the first 30 mothers and babies. Delivery using the Odon device is feasible.
A new prototypes of the BD Odon Device™ will be further tested in another study before potential introduction in clinical practice.