Physiologic Elasticity Changes During Pregnancy and After Labor.

Terminated

• Conditions: Vaginal Prolapse

• Registration Number: NCT03930290
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-29
• Study Start: 2019-08-01
• Primary Completion: 2020-07-31
• Study Completion: 2020-08-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-12
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

• Pregnant patients in their 2nd trimester.

Exclusion Criteria

• Pregnant patients presenting after their 2nd trimester.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaginal elasticity	From the beginning of the 2nd trimester of pregnancy up to 6 weeks postpartum.	Vaginal elasticity evaluation by vaginal tactile imaging analysis

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel