Vaginal ProlapseNCT03930290
Physiologic Elasticity Changes During Pregnancy and After Labor.
An observational study of Vaginal Prolapse, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Female pregnant patients in their 2nd trimester will be evaluated for vaginal elasticity using vaginal tactile imaging in addition to elasticity evaluation during the 3rd trimester and 6 weeks postpartum. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Vaginal Prolapse
- What is being tested?
- Vaginal tactile imager
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2019to 31 Aug 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant patients in their 2nd trimester with no regard to previous obstetric history.
Who may be able to join
- Pregnant patients in their 2nd trimester.
Who cannot join
- Pregnant patients presenting after their 2nd trimester.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaginal Tactile Imaging for the Assessment of Physiologic Elasticity Changes During Pregnancy and After Labor.
Female pregnant patients in their 2nd trimester will be evaluated for vaginal elasticity using vaginal tactile imaging in addition to elasticity evaluation during the 3rd trimester and 6 weeks postpartum.
Read the detailed description
Female pregnant patients in their 2nd trimester will be evaluated for vaginal elasticity using vaginal tactile imaging. Vaginal elasticity will also be evaluated during the 3rd trimester and 6 weeks postpartum.
Patients will be recruited and sign a consent form. Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points:
- During the 2nd trimester.
- During the 3rd trimester.
- 6 weeks postpartum. Every patient will serve as her own control. Demographic, gynecologic and obstetric history will be obtained from patients' electronic files.
- Conditions
- Vaginal Prolapse
- Being tested
- Vaginal tactile imager
- Medical subject headings
- Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal tactile imagerDiagnostic test
Vaginal elasticity evaluation by vaginal tactile imaging analysis.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant patients | Pregnant patients in their 2nd trimester. Receives: Diagnostic Test: Vaginal tactile imager |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal elasticity
Vaginal elasticity evaluation by vaginal tactile imaging analysis
Measured: From the beginning of the 2nd trimester of pregnancy up to 6 weeks postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start1 Aug 2019
- Primary completion31 Jul 2020
- Study completion31 Aug 2020
Why it stopped: Difficulty in patient recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal ProlapseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROY LAUTERBACH MD, Rambam Health Care Campus
- Investigators
- Roy Lauterbach, MD, Principal investigator, Rambam healthcare campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930290
- Sponsor's protocol ID
- 0567-18-RMB
- Status last verified
- Sep 2020
- First submitted
- 25 Apr 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Tactile Imaging for the Assessment of Physiologic Elasticity Changes During Pregnancy and After Labor.
- ClinicalTrials.gov ID
- NCT03930290
- Acronym / sponsor ID
- 0567-18-RMB
- Conditions
- Vaginal Prolapse
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty in patient recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 29 Apr 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.
Female pregnant patients in their 2nd trimester will be evaluated for vaginal elasticity using vaginal tactile imaging in addition to elasticity evaluation during the 3rd trimester and 6 weeks postpartum.
Detailed description
Female pregnant patients in their 2nd trimester will be evaluated for vaginal elasticity using vaginal tactile imaging. Vaginal elasticity will also be evaluated during the 3rd trimester and 6 weeks postpartum.
Patients will be recruited and sign a consent form. Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points:
- During the 2nd trimester.
- During the 3rd trimester.
- 6 weeks postpartum. Every patient will serve as her own control. Demographic, gynecologic and obstetric history will be obtained from patients' electronic files.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant patients | – | Diagnostic Test: Vaginal tactile imagerPregnant patients in their 2nd trimester. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant patients in their 2nd trimester with no regard to previous obstetric history.
Key inclusion criteria (1 listed)
- Pregnant patients in their 2nd trimester.
Key exclusion criteria (1 listed)
- Pregnant patients presenting after their 2nd trimester.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal tactile imagerVaginal elasticity evaluation by vaginal tactile imaging analysis. | Diagnostic test | Pregnant patients |
Primary outcome
Vaginal elasticity
Time frame: From the beginning of the 2nd trimester of pregnancy up to 6 weeks postpartum.
Vaginal elasticity evaluation by vaginal tactile imaging analysis
Results and safety
The study was stopped early (reason given: Difficulty in patient recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Roy Lauterbach, MD principal investigator
Rambam healthcare campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Prolapse, run by Rambam Health Care Campus at 1 site in Israel.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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 was stopped early (reason given: Difficulty in patient recruiting). Results are not available in the source record.
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?
Vaginal elasticity (time frame: From the beginning of the 2nd trimester of pregnancy up to 6 weeks postpartum.). 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 16 Sep 2020.