The specific aim of the proposed study is to test the safety and feasibility (Phase 1) and preliminary efficacy (Phase 2) of a new low cost device (Odon Device) to deliver the fetus during prolonged second stage of labor. Although the focus of the proposed study is on the Odon Device as an alternative to available management options for complicated second stage of labour, other potential indications to be studied in the future could include use for assistance during normal delivery and prevention of infections acquired during delivery.

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. 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 independent development of forceps and the vacuum extractor centuries ago. The Odon device could play a major role in improving intrapartum obstetric care in low resource settings by making possible effective management of intrapartum complications in facilities lacking surgical capacity and/or personnel adequately trained in the use of forceps and the vacuum extractor.

Intrapartum complications are responsible for approximately half of all maternal deaths and two million stillbirth and neonatal deaths per year. Prolonged second stage of labor is associated with potentially fatal maternal complications such as hemorrhage and infection and is a major cause of stillbirth and newborn morbidity and mortality. Evidence indicates that the majority of intrapartum deaths in low-resource settings could be prevented through the introduction of innovative strategies that would increase accessibility of obstetric care (e.g., task shifting). Technological developments such as the Odon device that reduce the skill level and equipment required to provide quality obstetric care are clearly needed.      

Currently, the three main options for managing prolonged second stage of labor are Cesarean section, forceps and vacuum extractor. All three clinical practices require relatively expensive equipment (e.g., a surgical theatre for cesarean section) and highly trained staff that are often not available in low resource settings. Even when these options are available, their use is associated with increased maternal and perinatal complications. Safe use of forceps requires very high-level training that is seldom available in low-resource settings. Use of the vacuum extractor is limited by the need for fairly complex equipment requiring maintenance, and it is contra-indicated in women who are HIV positive or with unknown HIV status.

The Odon device is a low cost, easy to use technological innovation to facilitate operative vaginal delivery and designed to minimize trauma to the mother and baby.  It may also protect the baby from intrapartum infection. These features combined make it a potentially revolutionary development in obstetrics, particularly for improving intrapartum care in low resource settings. 

The Odon Device was invented by Mr Jorge Odon who holds an intellectual property patent. Mr Odon does not have a medical or biological research background and will participate in the proposed study only in relation to issues on device development.

This study has been registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) as one of the Primary Registries in the WHO Registry Network. The registration number of this trial is ACTRN12613000141741.

The Department of Reproductive Health and Research (HRP/RHR) at the World Health Organization (WHO) is the sponsor of the trial and performs overall coordination.

The specific aim of the proposed study is to test the safety and feasibility (Phase 1) and preliminary efficacy (Phase 2) of a new low cost device (Odon Device) to deliver the fetus during prolonged second stage of labor. Although the focus of the proposed study is on the Odon Device as an alternative to available management options for complicated second stage of labour, other potential indications to be studied in the future could include use for assistance during normal delivery and prevention of infections acquired during delivery.

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. 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 independent development of forceps and the vacuum extractor centuries ago. The Odon device could play a major role in improving intrapartum obstetric care in low resource settings by making possible effective management of intrapartum complications in facilities lacking surgical capacity and/or personnel adequately trained in the use of forceps and the vacuum extractor.

Intrapartum complications are responsible for approximately half of all maternal deaths and two million stillbirth and neonatal deaths per year. Prolonged second stage of labor is associated with potentially fatal maternal complications such as hemorrhage and infection and is a major cause of stillbirth and newborn morbidity and mortality. Evidence indicates that the majority of intrapartum deaths in low-resource settings could be prevented through the introduction of innovative strategies that would increase accessibility of obstetric care (e.g., task shifting). Technological developments such as the Odon device that reduce the skill level and equipment required to provide quality obstetric care are clearly needed.      

Currently, the three main options for managing prolonged second stage of labor are Cesarean section, forceps and vacuum extractor. All three clinical practices require relatively expensive equipment (e.g., a surgical theatre for cesarean section) and highly trained staff that are often not available in low resource settings. Even when these options are available, their use is associated with increased maternal and perinatal complications. Safe use of forceps requires very high-level training that is seldom available in low-resource settings. Use of the vacuum extractor is limited by the need for fairly complex equipment requiring maintenance, and it is contra-indicated in women who are HIV positive or with unknown HIV status.

The Odon device is a low cost, easy to use technological innovation to facilitate operative vaginal delivery and designed to minimize trauma to the mother and baby.  It may also protect the baby from intrapartum infection. These features combined make it a potentially revolutionary development in obstetrics, particularly for improving intrapartum care in low resource settings. 

The Odon Device was invented by Mr Jorge Odon who holds an intellectual property patent. Mr Odon does not have a medical or biological research background and will participate in the proposed study only in relation to issues on device development.

This study has been registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) as one of the Primary Registries in the WHO Registry Network. The registration number of this trial is ACTRN12613000141741.

The Department of Reproductive Health and Research (HRP/RHR) at the World Health Organization (WHO) is the sponsor of the trial and performs overall coordination.