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
|Condition or disease|
|Pelvic Floor Perineal Rupture Obstetric Trauma|
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 Type :||Observational|
|Actual Enrollment :||20 participants|
|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|
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.
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.
- Cervix elasticity [ Time Frame: During examination procedure ]Cervix elasticity (kPa)
- Cervix length [ Time Frame: During examination procedure ]Cervix length (mm)
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
|United States, New Jersey|
|Rutgers The State University Of New Jersey|
|New Brunswick, New Jersey, United States, 08854|
|Princeton, New Jersey, United States, 08540|
|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|