Physiologic Elasticity Changes During Pregnancy and After Labor.

Vaginal Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03930290
• Other study ID #: 0567-18-RMB
• Status: Terminated
• Start date: August 1, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: September 2020
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: August 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pregnant patients in their 2nd trimester.

Exclusion Criteria:

• Pregnant patients presenting after their 2nd trimester.

Related Conditions & MeSH terms

• Prolapse
• Uterine Prolapse
• Vaginal Prolapse

Intervention

Diagnostic Test:
• Vaginal tactile imager
Vaginal elasticity evaluation by vaginal tactile imaging analysis.

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal elasticity	Vaginal elasticity evaluation by vaginal tactile imaging analysis	From the beginning of the 2nd trimester of pregnancy up to 6 weeks postpartum.