Background: A prolonged and complicated second stage of labour is associated with serious perinatal complications. The Odon device is an innovation intended to perform instrumental vaginal delivery presently under development. We present an evaluation of the feasibility and safety of delivery with early prototypes of this device from an early terminated clinical study.
Methods: Hospital-based, multi-phased, open-label, pilot clinical study with no control group in tertiary hospitals in Argentina and South Africa. Multiparous and nulliparous women, with uncomplicated singleton pregnancies, were enrolled during the third trimester of pregnancy. Delivery with Odon device was attempted under non-emergency conditions during the second stage of labour. The feasibility outcome was delivery with the Odon device defined as successful expulsion of the fetal head after one-time application of the device.
Results: Of the 49 women enrolled, the Odon device was inserted successfully in 46 (93%), and successful Odon device delivery as defined above was achieved in 35 (71%) women. Vaginal, first and second degree perineal tears occurred in 29 (59%) women. Four women had cervical tears. No third or fourth degree perineal tears were observed. All neonates were born alive and vigorous. No adverse maternal or infant outcomes were observed at 6-weeks follow-up for all dyads, and at 1 year for the first 30 dyads.
Conclusions: Delivery using the Odon device is feasible. Observed genital tears could be due to the device or the process of delivery and assessment bias. Evaluating the effectiveness and safety of the further developed prototype of the BD Odon Device™ will require a randomized-controlled trial.
Trial Registration: ANZCTR ACTRN12613000141741 Registered 06 February 2013. Retrospectively registered.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5846255 | PMC |
| http://dx.doi.org/10.1186/s12978-018-0485-8 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Associations of adiposity and device-measured physical activity with cancer incidence: UK Biobank prospective cohort study.
J Sport Health Sci
December 2024
Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo 0806, Norway.
Background: High adiposity and low physical activity are associated with cancer risk. Whether different amounts and intensities of physical activity can mitigate this association is unclear. We aimed to examine the independent and combined associations of adiposity and device-measured physical activity levels of different intensities with cancer incidence and mortality.
View Article and Find Full Text PDFCaffeine Enhances Some Aspects of Physical Performance in Well-Trained Hammer and Discus Throwers.
Nutrients
November 2024
Sport Training Laboratory (GIRD), Faculty of Sport Sciences, University of Castilla-La Mancha, 45004 Toledo, Spain.
Background: Caffeine is a widely recognized ergogenic aid for enhancing exercise performance. However, its effect on throwing performance has been less studied, yielding contradictory results.
Objectives: The main aim of the study was to analyze the potential ergogenic effects of a moderate dose of caffeine (3 mg·kg body mass) on vertical jump performance and throwing distance during a simulated competition in trained discus and hammer throwers.
Digital Device Usage and Childhood Cognitive Development: Exploring Effects on Cognitive Abilities.
Children (Basel)
October 2024
Faculty of Sport Sciences, European University of Madrid, 28670 Villaviciosa de Odón, Spain.
Unlabelled: The increasing ubiquity of digital devices in childhood had outpaced the understanding of their effects on cognitive development, creating a significant research gap regarding their long-term impact.
Objective: The present narrative overview explored the complex relationship between digital device usage and cognitive development in childhood.
Methods: We conducted a comprehensive literature search across multiple databases, including PubMed, Embase, Scopus, and Web of Science, to critically assess cognitive domains such as attention, memory, executive functions, problem-solving skills, and social cognition.
Impact of mechanical circulatory support on outcomes in Takotsubo syndrome complicated by cardiogenic shock: Insights from the RETAKO registry.
Int J Cardiol
January 2025
Department of Cardiology, Hospital Universitari Vall d'Hebron, Barcelona, Spain; Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, Spain; Department of Cardiology, Hospital Universitario de Torrejón, Madrid, Spain.
Background: Cardiogenic shock (CS) complicates Takotsubo syndrome (TTS), significantly affecting patient outcomes. Since avoiding catecholamines, particularly inotropic agents, is recommended in TTS, temporary mechanical circulatory support (MCS) shows promise as a bridge to recovery. However, there is no prospective data on its use in TTS.
View Article and Find Full Text PDFReal-World Use of Hybrid Closed-Loop Systems during Diabetes Camp: A Preliminary Study for Secure Configuration Strategies in Children and Adolescents.
Nutrients
July 2024
Andalucía Tech, Universidad de Málaga, Campus de Teatinos s/n, 29071 Málaga, Spain.
The introduction of closed-loop systems in the pediatric population has been a revolution in the management and evolution of diabetes. However, there are not many published studies in situations in which the feeding, schedules, and activities of the children deviate from the routine for which the systems were programmed, as in the case of a summer camp for children and adolescents with diabetes, where the specific programming of this device is not well known. It was a single-center prospective preliminary study.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!