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

Pelvic Floor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03883867
• Other study ID #: VTI 10
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Obstetric Trauma
• Pelvic Floor
• Perineal Rupture
• Rupture

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