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

Completed

• Conditions: Obstetric Trauma; Perineal Rupture; Pelvic Floor

• Registration Number: NCT03883867
• Lead Sponsor: Advanced Tactile Imaging, Inc.

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.

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 Timeline

• Study Start: 2019-03-08
• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-20
• Study First Posted: 2019-03-21
• Primary Completion: 2020-01-10
• Study Completion: 2020-02-25
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-09
• Last Update Posted: 2020-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (3)

Princeton Urogynecology; 🇺🇸 Princeton, New Jersey, United States

Rutgers The State University Of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

Department of Gynecology and Obstetrics University Hospital; 🇨🇿 Pilsen, Czechia