Odon Device for Assisted Vaginal Delivery
Complications due to prolonged second stage of labor include potentially fatal maternal (hemorrhage, infection) and newborn complications (birth asphyxia and trauma).
The specific aim of the proposed study is to test the safety and feasibility of a new low cost device (Odon Device http://www.youtube.com/watch?v=OGLLXFzULd4) to deliver the fetus during the second stage of labor. This device may be potentially safer and easier to apply than forceps/vacuum extractor for assisted deliveries, and a safe alternative to some Caesarean sections in settings with limited surgical capacity and human resource constraints. It has potential for wide application in resource poor settings even by mid-level providers. If proven safe and effective, the Odon Device will be the first innovation in operative vaginal delivery since the development of forceps centuries ago and vacuum extractor decades ago.
We will introduce a two-phased study protocol in health care facilities in Argentina and rural South Africa. During phase 1, the device will be tested for safety and feasibility under normal delivery conditions. Testing has already started at a tertiary care center in Argentina in the context of WHO study A65711. During phase 2, the device will be tested for preliminary efficacy (successful delivery of the baby without the need to resort to cesarean section/forceps/vacuum extractor) in deliveries with prolonged second stage of labour and no fetal distress through a randomized controlled trial.
Study results will inform future research to assess effectiveness of the Odon device in reducing negative obstetrical outcomes including newborn infections acquired intrapartum.