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

Study Overview
=================
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.

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

Conditions
-----------------
Pelvic Floor, Perineal Rupture, Obstetric Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
Female

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal<br>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<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelvic Floor, Perineal Rapture, Obstetric Trauma