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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03883867
Enrollment
20
Registered
2019-03-21
Start date
2019-03-08
Completion date
2020-02-25
Last updated
2020-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric Trauma, Pelvic Floor, Perineal Rupture

Keywords

Pelvic Floor, Perineal Rapture, Obstetric Trauma

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.

Interventions

None listed

Sponsors

Advanced Tactile Imaging, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Prineum elasticityDuring examination procedureMeasurement in units of elasticity, Young's modulus, kPa
Distance between pubic bone and perineum at 20 kPa loadDuring examination procedureMeasurement in unit of distance, mm

Countries

Czechia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026