Pelvic FloorNCT03883867
Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions Before the Delivery
An observational study of Pelvic Floor and Perineal Rupture, run by Advanced Tactile Imaging, Inc. at 3 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Pelvic Floor, Perineal Rupture, Obstetric Trauma
- How many people
- 20 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 8 Mar 2019to 25 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Rutgers The State University Of New Jersey
New Brunswick, New Jersey, 08854
Princeton Urogynecology
Princeton, New Jersey, 08540
Czechia1 site
Department of Gynecology and Obstetrics University Hospital
Pilsen, 30460
About this study
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.
Read the 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.
- Conditions
- Pelvic Floor, Perineal Rupture, Obstetric Trauma
- Keywords
- Pelvic Floor, Perineal Rapture, Obstetric Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prineum elasticity
Measurement in units of elasticity, Young's modulus, kPa
Measured: During examination procedure
Distance between pubic bone and perineum at 20 kPa load
Measurement in unit of distance, mm
Measured: During examination procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start8 Mar 2019
- Primary completion10 Jan 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic FloorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Tactile Imaging, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vladimir Egorov, PhD, Principal investigator, Advanced Tactile Imaging, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883867
- Sponsor's protocol ID
- VTI 10
- Status last verified
- Apr 2020
- First submitted
- 19 Mar 2019
- Last updated
- 13 Apr 2020
- Results posted
- No
- Individual data sharing
- No: Will be published.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions Before the Delivery
- ClinicalTrials.gov ID
- NCT03883867
- Acronym / sponsor ID
- VTI 10
- Conditions
- Pelvic Floor, Perineal Rupture, Obstetric Trauma
- Keywords
- Pelvic Floor, Perineal Rapture, Obstetric Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Advanced Tactile Imaging, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prineum elasticity
Time frame: During examination procedure
Measurement in units of elasticity, Young's modulus, kPa
Distance between pubic bone and perineum at 20 kPa load
Time frame: During examination procedure
Measurement in unit of distance, mm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Individual participant dataSharing planned: No. Will be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Egorov, PhD principal investigator
Advanced Tactile Imaging, Inc.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor and Perineal Rupture, run by Advanced Tactile Imaging, Inc. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prineum elasticity (time frame: During examination procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.