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.

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Key information

Conditions

Pelvic Floor Obstetric Trauma Perineal Rupture

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Gynecology and Obstetrics University Hospital, Pilsen, Czechia

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Prineum elasticity

Time frame: During examination procedure

Measurement in units of elasticity, Young's modulus, kPa
Distance between pubic bone and perineum at 20 kPa load

Time frame: During examination procedure

Measurement in unit of distance, mm

Sponsors and collaborators

Lead sponsor

Advanced Tactile Imaging, Inc.

Industry

Registry information

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Mar 21, 2019
Registry last updated: Apr 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed