Pelvic Floor Clinical Trial
Official title:
Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions Before the Delivery
The mechanical demands placed on the pelvic floor structures during vaginal delivery often exceed physiological tissue limits, resulting in maternal childbirth trauma, considerable postpartum morbidity, and increased risk of pelvic floor disorders(PFD). Injury to the perineum, vaginal supportive tissues, and pelvic floor muscles cause pain, infection, and dyspareunia, as well as pelvic organ prolapse(POP).Pregnancy and vaginal delivery are considered as a main risk factors in weakening the pelvic floor support and development of SUI, AI, and POP. CS is not only available countermeasure to reduce occurrence of obstetric trauma. Tactile imaging allows acquisition of 3D stress-strain data and 3D elasticity imaging or soft tissues.
The long - term of this project is to develop, validate, and integrate into clinical practice
a new paradigm and a novel device to simultaneously measure the biomechanical properties of
various pelvic structural components that are impacted during vaginal delivery, and to
develop a risk prediction model of maternal birth injury. Ultimately, such a model will
enable individualized patient counseling regarding the mode of delivery and/or the need for
obstetrical interventions to reduce child birth trauma. The approach will utilize the vaginal
tactile imaging technology that the investigators have developed and validated for clinical
use.
The benefits to physicians, patients and society are expected to be significant because the
painful event in woman's life , given the large proportion of women suffer PFD caused by
childbirth.
This new system may open a new technical capability in woman's healthcare and change the
established clinical practice.
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