Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions Before the Delivery
Completed
Conditions studied: Pelvic Floor, Perineal Rupture, Obstetric Trauma
In brief
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.
Key facts
- Study ID
- NCT03883867
- Run by
- Advanced Tactile Imaging, Inc.
- People needed
- 20
- Starts
- 2019-03-08
- Expected to finish
- 2020-02-25
- Last updated by the study team
- 2020-04-13
Who can join
Age: 21 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Non-pregnant women (Princeton Urogynecology, Princeton, NJ)
- 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)
You may not qualify if…
- Prior perineal surgery
- HIV or hepatitis B positive serology
- Warty lesions on the vulva
- Extensive varicose veins on the vulva
- Aactive skin infection or ulceration within the vagina/vulva
- Presence of vaginal septum
- Severe hemorrhoids
- Stillbirth or extensive congenital abnormalities of the fetus
Where it is running
- Rutgers The State University Of New Jersey — New Brunswick, New Jersey, United States
- Princeton Urogynecology — Princeton, New Jersey, United States
- Department of Gynecology and Obstetrics University Hospital — Pilsen, Czechia
Full record on ClinicalTrials.gov
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