Desarrollo de un prototipo biomédico para la medición de parámetros cervicales en la fase latente del trabajo de parto, considerando criterios normativos de diseño de equipos médico

Abstract

Vaginal examination (VE) is a routine clinical procedure for assessing the progress of labor; however, its recurrent use has been linked to an increased risk of maternal-fetal complications, especially in cases of premature rupture of membranes. Scientific data indicate a proportional relationship between the number of vaginal examinations and the frequency of infections such as chorioamnionitis, as well as the risk of hemorrhage, cervical injury, and iatrogenic events. In this context, the present research aimed to create and evaluate a technological tool designed to reduce or replace conventional vaginal examination, focusing on safety, accuracy, and clinical feasibility. A literature review was conducted on the risks associated with VE, and surveys were administered to women to analyze their perceptions and level of acceptance of a technological alternative. Interviews were also conducted with healthcare experts specializing in obstetrics to obtain clinical, technical, and ethical criteria to guide the design of the device. The findings showed positive acceptance of the creation of a novel tool, provided it ensures maternal-fetal safety and reduces invasiveness. Based on these results, a working prototype was created using a Raspberry Pi 3B as the central processing unit, chosen for its affordability, flexibility, and ability to integrate with biomedical sensors. The development took into account user-centered design principles, biosafety criteria, and technical feasibility, in accordance with the role of the biomedical engineer in creating innovative medical solutions. It was determined that the application of embedded systems technologies represents a promising option for improving labor assessment and strengthening safety in obstetric care.