New challenges in operative vaginal delivery: the Odon device. A systematic review

Abstract

Operative vaginal delivery is the best option for accelerating labor in the second stage labor; however, this technique requires precise clinical assessment, customized care, skilled and appropriately educated workers, in order to avoid both maternal and fetal complications. The aim of this systematic review is to analyze the innovation, design, and effectiveness of a new instrument for Operative Vaginal Delivery, the Odon device, in order to improve intrapartum obstetric care in clinical practice, to facilitate the instrumental vaginal birth, and increase maternal and neonatal outcomes. A literature search was conducted thought electronic databases PubMed, EMBASE, Web Of Science. We considered papers published online from 2000 until January 2025, reporting the use of Odon device for operative vaginal delivery. The research was performed utilizing the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standards. Two reviewers independently screened the abstracts of the selected studies and extracted data from full-text articles. The data were subsequently tabulated and evaluated. We selected 14 studies suitable for this systematic review. The operative vaginal birth is expedited with the Odon Device, which reported a safe, feasible and effective profile, both for structural characteristics and clinical application. There are no serious maternal and neonatal adverse events related to the use of the device during birth. There are no serious adverse device effects. The operators reported elevated value of satisfaction about the use and application of this new instrument. A favorable evaluation and positive experience were reported also by pregnant women and obstetrics. In conclusion, phase I and II trials show that the Odon device has satisfactory safety, feasibility, and efficacy profile, so it may be considered for potential clinical uses in addition to existing procedures for operative vaginal delivery. Randomized clinical studies are required to clarify the potentials benefits associated with the use of the Odon device on newborns in comparison to other instruments for OVD.

Keywords: Odon; Operative vaginal birth; Perineal tears.