Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions Before the Delivery
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 3/23/2019 |
| Start Date: | March 8, 2019 |
| End Date: | May 30, 2019 |
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.
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.
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.
Inclusion Criteria: Adult women in reproductive age falling into one of the following
groups:
1. Non-pregnant women (Princeton Urogynecology, Princeton, NJ)
2. Pregnant women after completed 35th week of pregnancy with fetus in vertex position
and premise of vaginal delivery (Division of Maternal-Fetal Medicine, Rutgers Robert
Wood Johnson Medical School, New Brunswick, NJ)
Exclusion Criteria: Prior perineal surgery, HIV or hepatitis B positive serology, warty
lesions on the vulva, extensive varicose veins on the vulva, active skin infection or
ulceration within the vagina/vulva, presence of vaginal septum, severe hemorrhoids,
stillbirth or extensive congenital abnormalities of the fetus.
We found this trial at
1
site
Click here to add this to my saved trials
