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NCT03883867 · ClinicalTrials.gov registry record
Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions Before the Delivery
A clinical trial of Pelvic Floor and Perineal Rupture, sponsored by Advanced Tactile Imaging.
- Completed
- Registry status
- 20
- Enrollment target
- 3
- Study locations
NCT03883867: Completed study of Pelvic Floor and Perineal Rupture, sponsored by Advanced Tactile Imaging.
NCT03883867 is a study of Pelvic Floor and Perineal Rupture that has completed, run by Advanced Tactile Imaging. The registered enrollment target is 20 participants. The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03883867, a study of Pelvic Floor and Perineal Rupture, has completed, sponsored by Advanced Tactile Imaging.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
Measurement in units of elasticity, Young's modulus, kPa
Conditions Studied
Study Locations (3)
New Jersey
- Rutgers The State University Of New Jersey - New Brunswick
- Princeton Urogynecology - Princeton
Other
- Department of Gynecology and Obstetrics University Hospital - Pilsen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-03-08 |
| Est. Completion | 2020-02-25 |
What the finished NCT03883867 record still lists
NCT03883867 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 3 conditions, with Pelvic Floor appearing as the primary indexed condition, and to 0 interventions.
NCT03883867 reports a single indexed study location in New Jersey, Other.
Frequently Asked Questions
What is clinical trial NCT03883867 about?
NCT03883867 is a clinical study titled "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 tis...
What is the current status of trial NCT03883867?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2019-03-08. Estimated completion is 2020-02-25.
What conditions does trial NCT03883867 study?
This clinical trial studies the following conditions: Pelvic Floor, Perineal Rupture, Obstetric Trauma.
Who is sponsoring clinical trial NCT03883867?
This trial is sponsored by Advanced Tactile Imaging, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03883867 being conducted?
This trial has 3 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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