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Physiologic Elasticity Changes During Pregnancy and After Labor.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03930290
Recruitment Status : Terminated (Difficulty in patient recruiting)
First Posted : April 29, 2019
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
ROY LAUTERBACH MD, Rambam Health Care Campus

Brief 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.

Condition or disease Intervention/treatment
Vaginal Prolapse Diagnostic Test: Vaginal tactile imager

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.

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vaginal Tactile Imaging for the Assessment of Physiologic Elasticity Changes During Pregnancy and After Labor.
Actual Study Start Date : August 1, 2019
Actual Primary Completion Date : July 31, 2020
Actual Study Completion Date : August 31, 2020

Group/Cohort Intervention/treatment
Pregnant patients
Pregnant patients in their 2nd trimester.
Diagnostic Test: Vaginal tactile imager
Vaginal elasticity evaluation by vaginal tactile imaging analysis.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnancy
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant patients in their 2nd trimester with no regard to previous obstetric history.
Criteria

Inclusion Criteria:

  • Pregnant patients in their 2nd trimester.

Exclusion Criteria:

  • Pregnant patients presenting after their 2nd trimester.

Information from the National Library of Medicine

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): NCT03930290


Locations
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Israel
Rambam health care campus
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Roy Lauterbach, MD Rambam healthcare campus
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Responsible Party: ROY LAUTERBACH MD, Principal Investigator, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03930290    
Other Study ID Numbers: 0567-18-RMB
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Prolapse
Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Pelvic Organ Prolapse