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

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ClinicalTrials.gov Identifier: NCT03883867
Recruitment Status : Enrolling by invitation
First Posted : March 21, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Pelvic Floor Perineal Rupture Obstetric Trauma

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.


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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions Before the Delivery
Actual Study Start Date : March 8, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Normal
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
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.



Primary Outcome Measures :
  1. Cervix elasticity [ Time Frame: During examination procedure ]
    Cervix elasticity (kPa)

  2. Cervix length [ Time Frame: During examination procedure ]
    Cervix length (mm)



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women in reproductive age
Sampling Method:   Non-Probability Sample
Study Population

The subject population will include 20 subjects. First group involves 10 non-pregnant women 5 of them will have 2 tactile imaging examinations completed in one session 5 others will have single tactile imaging examination.

Second group involves 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 36 week of an uncomplicated pregnancy.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883867


Locations
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United States, New Jersey
Rutgers The State University Of New Jersey
New Brunswick, New Jersey, United States, 08854
Princeton Urogynecology
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Advanced Tactile Imaging, Inc.
Investigators
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Principal Investigator: Heather van Raalte, MD Princeton Urogynecology, Princeton New Jersey United States
Principal Investigator: Todd Joshua Rosen, MD Rutgers The State University Of New Jersey, New Jersey United States
  Study Documents (Full-Text)

Documents provided by Advanced Tactile Imaging, Inc.:
Study Protocol and Informed Consent Form  [PDF] January 16, 2019


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Responsible Party: Advanced Tactile Imaging, Inc.
ClinicalTrials.gov Identifier: NCT03883867     History of Changes
Other Study ID Numbers: VTI 10
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Will be published.

Keywords provided by Advanced Tactile Imaging, Inc.:
Pelvic Floor, Perineal Rapture, Obstetric Trauma

Additional relevant MeSH terms:
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Rupture
Wounds and Injuries