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
|Condition or disease||Intervention/treatment|
|Vaginal Prolapse||Diagnostic Test: Vaginal tactile imager|
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 Type :||Observational|
|Actual Enrollment :||12 participants|
|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|
Pregnant patients in their 2nd trimester.
Diagnostic Test: Vaginal tactile imager
Vaginal elasticity evaluation by vaginal tactile imaging analysis.
- 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
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
|Rambam health care campus|
|Principal Investigator:||Roy Lauterbach, MD||Rambam healthcare campus|