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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03883867
Other study ID # VTI 10
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 8, 2019
Est. completion date February 25, 2020

Study information

Verified date April 2020
Source Advanced Tactile Imaging, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date February 25, 2020
Est. primary completion date January 10, 2020
Accepts healthy volunteers
Gender Female
Age group 21 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Czechia Department of Gynecology and Obstetrics University Hospital Pilsen
United States Rutgers The State University Of New Jersey New Brunswick New Jersey
United States Princeton Urogynecology Princeton New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Advanced Tactile Imaging, Inc.

Countries where clinical trial is conducted

United States,  Czechia, 

Outcome

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