Abstract
BackgroundIntrapartum complications are responsible for approximately half of all maternal deaths, and two million stillbirth and neonatal deaths per year. Prolonged second stage of labour is associated with potentially fatal maternal complications such as haemorrhage and infection and it is a major cause of stillbirth and newborn morbidity and mortality. Currently, the three main options for managing prolonged second stage of labour are forceps, vacuum extractor and caesarean section. All three clinical practices require relatively expensive equipment (e.g., a surgical theatre for caesarean section) and/or highly trained staff which are often not available in low resource settings. The specific aim of the proposed study is to test the safety and feasibility of a new device (Odón device) to effectively deliver the fetus during prolonged second stage of labour. The Odón device is a low-cost technological innovation to facilitate operative vaginal delivery and designed to minimize trauma to the mother and baby. These features combined make it a potentially revolutionary development in obstetrics, particularly for improving intrapartum care and reducing maternal and perinatal morbidity and mortality in low resource settings.Methods/designThis will be a hospital-based, multicenter prospective phase 1 cohort study with no control group. Delivery with the Odón device will be attempted under normal labour and non-emergency conditions on all the women enrolled in the study. One-hundred and thirty pregnant women will be recruited in tertiary care facilities in Argentina. Safety will be assessed by examining maternal and infant outcomes until discharge. Feasibility will be evaluated by observing successful expulsion of the fetal head after one-time application of the device under standardized conditions (full cervical dilation, anterior presentation, +2 station, normal fetal heart rate).Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR). Identifier: ACTRN12613000141741
Highlights
Intrapartum complications are responsible for approximately half of all maternal deaths, and two million stillbirth and neonatal deaths per year [1,2,3,4,5]
Prolonged second stage of labour is associated with potentially fatal maternal complications such as haemorrhage and infection and it is a major cause of stillbirth and newborn morbidity and mortality
Study hypothesis and objectives The main objective of this study is to evaluate the safety and feasibility, in terms of ease of application and successful use of the Odón device in assisting vaginal delivery in singleton term pregnancies during the second stage of labour
Summary
Intrapartum complications are responsible for approximately half of all maternal deaths, and two million stillbirth and neonatal deaths per year [1,2,3,4,5]. Study hypothesis and objectives The main objective of this study is to evaluate the safety and feasibility, in terms of ease of application and successful use of the Odón device in assisting vaginal delivery in singleton term pregnancies during the second stage of labour. Feasibility will be evaluated by observing successful expulsion of the fetal head after one-time application of the device under standardized conditions (full cervical dilation, anterior presentation, +2 station, normal fetal heart rate) in singleton non-complicated pregnancies. PHASE 2: the device will be tested for preliminary efficacy (successful delivery of the baby without the need to resort to caesarean section/forceps/vacuum extractor) in deliveries with prolonged second stage of labour with an indication for not immediate operative delivery (allowing enough time for the application of the Odón device prior to standard of care) and no signs of fetal distress. Consent will be obtained before the initiation of labour and women will be able to withdraw from the study at any time
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