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

NCT03883867 | Completed

• 1 other identifier: VTI 10
• Study Type: observational
• Target: 20
• Locations: 2 countries
• Sites: 3

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.

Conditions

Pelvic Floor; Perineal Rupture; Obstetric Trauma

Keywords

Pelvic Floor, Perineal Rapture, Obstetric Trauma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: women in reproductive age
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Advanced Tactile Imaging, Inc.: lead

Study Sites (3)

Rutgers The State University Of New Jersey

New Brunswick, New Jersey, 08854, United States

Location

Princeton Urogynecology

Princeton, New Jersey, 08540, United States

Location

Department of Gynecology and Obstetrics University Hospital

Pilsen, 30460, Czechia

Location

Study Officials

• Vladimir Egorov, PhD

  Advanced Tactile Imaging, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 21, 2019
• Study Start: March 8, 2019
• Primary Completion: January 10, 2020
• Study Completion: February 25, 2020
• Last Updated: April 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); US (2)