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Clinical Trials/NCT03930290
NCT03930290
Terminated
Not Applicable

Vaginal Tactile Imaging for the Assessment of Physiologic Elasticity Changes During Pregnancy and After Labor.

Rambam Health Care Campus1 site in 1 country12 target enrollmentAugust 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vaginal Prolapse
Sponsor
Rambam Health Care Campus
Enrollment
12
Locations
1
Primary Endpoint
Vaginal elasticity
Status
Terminated
Last Updated
5 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2019
End Date
August 31, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

ROY LAUTERBACH MD

Principal Investigator

Rambam Health Care Campus

Eligibility Criteria

Inclusion Criteria

  • Pregnant patients in their 2nd trimester.

Exclusion Criteria

  • Pregnant patients presenting after their 2nd trimester.

Outcomes

Primary Outcomes

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

Study Sites (1)

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