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.

Study Overview

• Status: Completed
• Conditions: Pelvic Floor; Obstetric Trauma; Perineal Rupture

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Czechia
  • Pilsen, Czechia, 30460
    • Department of Gynecology and Obstetrics University Hospital
• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08854
      • Rutgers The State University of New Jersey
    • Princeton, New Jersey, United States, 08540
      • Princeton Urogynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prineum elasticity	Measurement in units of elasticity, Young's modulus, kPa	During examination procedure
Distance between pubic bone and perineum at 20 kPa load	Measurement in unit of distance, mm	During examination procedure

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2019
• Primary Completion (Actual): January 10, 2020
• Study Completion (Actual): February 25, 2020

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): April 13, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Pelvic Floor, Perineal Rapture, Obstetric Trauma
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: VTI 10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Will be published.