Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03930290
Other study ID # 0567-18-RMB
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
See also
  Status Clinical Trial Phase
Recruiting NCT04701047 - Prospective Observational Prolapse Study
Recruiting NCT03664986 - Pudendal Block Using Liposomal Bupivacaine vs. Standard Treatment During Sacrospinous Ligament Fixation Phase 4
Completed NCT00388947 - Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products N/A
Active, not recruiting NCT00442247 - A Randomised, Controlled Study of Bimesh, Pelvicol for Vaginal Wall Prolapse N/A
Not yet recruiting NCT04078802 - 0050-19-RMB CTIL - VNOTES Compared to VH for Vaginal Apex Prolapse N/A
Recruiting NCT00918099 - The Use of Avaulta for Anterior Repair N/A
Completed NCT00769054 - Local Infiltration Analgesia With Ropivacaine in Posterior Vaginal Wall Prolapse:a Randomized, Double-Blind Study Phase 4
Completed NCT03187574 - Comparison of Two Vaginal Mesh Kits in the Management of Vaginal Prolapse N/A
Completed NCT00679276 - Treatment Outcomes of Vaginal Prolapse Repair N/A
Completed NCT03338400 - Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Prolapse Surgery: Is There A Role? Phase 2
Completed NCT00153231 - Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair Phase 4
Completed NCT01409902 - Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue N/A
Completed NCT00557882 - Efficacy Study of Vaginal Mesh for Anterior Prolapse Phase 4
Completed NCT00196495 - Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse Phase 4
Not yet recruiting NCT06234449 - The Impact of Long-term Pessary Use on Pelvic Organ Prolapse oìduring Covid-19 Pandemic in Patients Attending Surgery
Active, not recruiting NCT03658395 - Sacrocolpopexy With Posterior Repair Obstructed Defecation Symptoms N/A
Recruiting NCT05449054 - Continuous Stitches Versus Simple Interrupted Stitches for Anterior Colporrhaphy N/A
Completed NCT00475540 - Efficacy Study of Vaginal Mesh for Prolapse N/A
Enrolling by invitation NCT00571350 - Anterior Vaginal Wall Reconstruction Phase 1/Phase 2
Not yet recruiting NCT03333811 - Sexual Function After Vaginal Repair With Perineorrhaphy N/A