Clinical trial NCT03883867: Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions Before the Delivery
Official title: Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions Before the Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Floor
Perineal Rupture
Obstetric Trauma
Keywords: Pelvic Floor, Perineal Rapture, Obstetric Trauma
Lead sponsor: Advanced Tactile Imaging, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subject population will include 20 subjects. First group involves 10 non-pregnant women 5 of them will have 2 tactile imaging examinations completed in one session 5 others will have single tactile imaging examination.

Second group involves 10 pregnant women without known complications at 36-37 weeks of pregnancy scheduled for a regular examination. All pregnant subjects should be examined weekly after completing 36 week of an uncomplicated pregnancy.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Prineum elasticity
timeFrame: During examination procedure
measure: Distance between pubic bone and perineum at 20 kPa load
timeFrame: During examination procedure
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers The State University Of New Jersey
state: New Jersey
city: Princeton
country: United States
facility: Princeton Urogynecology
state: New Jersey
city: Pilsen
country: Czechia
facility: Department of Gynecology and Obstetrics University Hospital
Study officials:
affiliation: Advanced Tactile Imaging, Inc.
name: Vladimir Egorov, PhD
role: PRINCIPAL_INVESTIGATOR
References: