Feasibility and safety study of a new device (Odón device) for assisted vaginal deliveries: study protocol

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

Exploring the reporting standards of RCTs involving invasive procedures for assisted vaginal birth: A systematic review

“…One paper provided further information: ‘participants in the first phase were asked for written consent to [video] tape the application of the Odón device. These tapes were made available to the DSMB for safety evaluation purposes.’ However, no clarification was provided about who analysed the videos and the standards to which they were assessed [ 32 ]. The final paper of the Odon Device provided details of adherence in its published protocol; ‘an integrated qualitative study…will investigate: the practitioners’ use of the device to ensure that an appropriate training package is developed for trial; enable to intervention to be described and refined to optimise its use….’ [ 2 ]…”

Odon device: a promising tool to facilitate vaginal delivery and increase access to emergency care

“…In this journal, the World Health Organization Odon Device Research Group describes the protocol for a feasibility and safety study of a new device (Odon device) for assisted vaginal deliveries [1]. This device is a low cost, easy to use technological innovation to facilitate operative vaginal delivery when complications occur during the second stage of labor.…”