Clincosm LogoSign in Get a demo

Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions Before the Delivery

Sponsor
Advanced Tactile Imaging, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03883867
Collaborator
(none)
20
Enrollment
3
Locations
11.6
Actual Duration (Months)
6.7
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions Before the Delivery
    Actual Study Start Date :
    Mar 8, 2019
    Actual Primary Completion Date :
    Jan 10, 2020
    Actual Study Completion Date :
    Feb 25, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Normal

    The subject population will involve 10 non-pregnant women. The tactile imaging reprifucibility sub-group will include 5 non-pregnant subjects with 2 tactile imaging examinations completed in one session. All other subjects will have a single tactile imaging examination.
    Pregnant

    The subject population will involve 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 36th week of an uncomplicated pregnancy. Routine gynecologic examination includes external and internal obstetrical examination.

    Outcome Measures

    Primary Outcome Measures

    1. Prineum elasticity [During examination procedure]

      Measurement in units of elasticity, Young's modulus, kPa

    2. Distance between pubic bone and perineum at 20 kPa load [During examination procedure]

      Measurement in unit of distance, mm

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    Female
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rutgers The State University Of New Jersey New Brunswick New Jersey United States 08854
    2 Princeton Urogynecology Princeton New Jersey United States 08540
    3 Department of Gynecology and Obstetrics University Hospital Pilsen Czechia 30460

    Sponsors and Collaborators

    • Advanced Tactile Imaging, Inc.

    Investigators

    • Principal Investigator: Vladimir Egorov, PhD, Advanced Tactile Imaging, Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Advanced Tactile Imaging, Inc.
    ClinicalTrials.gov Identifier:
    NCT03883867
    Other Study ID Numbers:
    • VTI 10
    First Posted:
    Mar 21, 2019
    Last Update Posted:
    Apr 13, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Advanced Tactile Imaging, Inc.
    Pelvic Floor, Perineal Rapture, Obstetric Trauma
    Additional relevant MeSH terms:
    Rupture

    Study Results

    No Results Posted as of Apr 13, 2020