The Odon Device is an assistive delivery device for mothers experiencing prolonged labor.
The Odon Device was designed for assistive birth delivery in cases of prolonged labor, transverse, or breech babies. The device, which is currently under development, is intended to reduce complications from prolonged labor, such as infection, and newborn complications, such as birth asphyxia.
Africa, South America
Forceps, vacuum extraction, C-section
Goal 3: Good health and well-being
Health care workers: obstetricians, nurses, midwives
The Becton Dickinson Company has the rights to manufacture the Odon Device, however, manufacturing has not yet begun.
Product is not yet available on the market
The exact number of devices distributed is unknown as the product is still in clinical trials.
forceps, vacuum, etc?
The product consists of a soft plastic cup that fits around the head of the baby, an inserter that grasps the head, and a polyethylene sleeve that is inflated with air that allows for guidance of the baby out of the birth canal. A force of up to 19 kg can be applied to aid in the extraction process.
Performance targets include: low cost, compact dimensions, usable globally, ease of use, safe for both fetus and mother, reduces risk of inoculability between mother and child.
The WHO Human Reproduction Program supported the evaluation of this product in hospitals in Argentina and South Africa. The device was successfully inserted into 93% of women, and 71% had a successful delivery after one-time application.
There are risks of mechanical failure while operating, and of maternal or newborn trauma during use.
Requejo, J.H. and Belizán, J.M., 2013, Odon Device: a Promising Tool to Facilitate Vaginal Delivery and Increase Access to Emergency Care, Reproductive Health, 10(1), p. 42.
World Health Organization Odon Device Research Group, 2013, Feasibility and Safety Study of a New Device (Odón Device) for Assisted Vaginal Deliveries: Study Protocol, Reproductive health, 10(1), p. 33.
Schvartzman, J., Krupitski, H., Merialdi, M., Betran, A.P. and Requejo, J., 2018, Odon Device for Instrumental Vaginal Deliveries: Results of a Medical Device Pilot Clinical Study, Reproductive health, 15(1), p. 45.
O’brien, S., Winter, C., Burden, C., Boulvain, M., Draycott, T., and Crofts, J., 2017, Fetal Head Position and Perineal Distension Associated with the Use of the BD Odon Device™ in Operative Vaginal Birth: a Simulation Study, BJOG: An International Journal of Obstetrics & Gynaecology, 124, pp. 10–18.
O’brien, S., Mouser, A., Odon, J., Winter, C., Draycott, T., Sumitro, T., Alisantoso, D., Lim, W., Merialdi, M., Stankovic, A., et al, 2017, Design and Development of the BD Odon DeviceTM: a Human Factors Evaluation Process, BJOG: An International Journal of Obstetrics & Gynaecology, 124, pp. 35–43.
O’brien, S., Winter, C., Burden, C., Boulvain, M., Draycott, T., and Crofts, J., 2017, Pressure and Traction on a Model Fetal Head and Neck Associated with the use of Forceps, Kiwi™ Ventouse and the BD Odon Device™ in Operative Vaginal Birth: a Simulation Study, BJOG: An International Journal of Obstetrics & Gynaecology, 124, pp. 19–25.
The device has not been approved for use in the US but has been evaluated by the WHO, which found that the device was feasible but will require a randomized-controlled trial to evaluate effectiveness and safety compared to other accepted methods.
The initial study included 49 women (some during their first delivery and some who had previously delivered). Each subject had an uncomplicated delivery and only one fetus. The device was tested in the late stage of labor. The study was done in a hospital in Argentina and one in South Africa.
The manufacturer now plans to pursue a randomized pivotal clinical trial (as of March 2018).
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