New instrument for assisted vaginal delivery
Last Updated: March 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 to be safe, or if complications arise, for example if the 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 a new prototype.
HRP supported research to evaluate whether this new device may help pushing the baby through the birth canal. The study included 49 women undergoing their first delivery as well as women who had previously delivered. The women’s pregnancies were uncomplicated and each had only one fetus. The study took place in two hospitals ̶ one in Argentina and the other in 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 (93%), and successful delivery with expulsion of the fetal head after one-time application of the Odon device was achieved in 35 women (71%). Some form of trauma to the genital tract (vaginal or perineum) occurred in 29 women (59%). This could be considered an average frequency of genital tears compared to findings published in the scientific literature. As use in humans has been limited, however, an increased risk of genital trauma and other unknown risks cannot be ruled out. All babies were born alive and vigorous. Follow up at 6 weeks and one year for the first 30 mothers and babies showed no adverse maternal or infant outcomes. Delivery using the Odon device is therefore considered to be feasible.
The study was ended after the 49th case following a decision by BD, the manufacturer of the device, to pursue a randomized pivotal clinical trial before potential introduction in clinical practice.