Physiologic Elasticity Changes During Pregnancy and After Labor.

Sponsor
Rambam Health Care Campus (Other)
Overall Status
Terminated
CT.gov ID
NCT03930290
Collaborator
(none)
12
1
13
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Vaginal tactile imager

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 Design

Study Type:
Observational
Actual Enrollment :
12 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Vaginal Tactile Imaging for the Assessment of Physiologic Elasticity Changes During Pregnancy and After Labor.
Actual Study Start Date :
Aug 1, 2019
Actual Primary Completion Date :
Jul 31, 2020
Actual Study Completion Date :
Aug 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Pregnant patients

Pregnant patients in their 2nd trimester.

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

Outcome Measures

Primary Outcome Measures

  1. Vaginal elasticity [From the beginning of the 2nd trimester of pregnancy up to 6 weeks postpartum.]

    Vaginal elasticity evaluation by vaginal tactile imaging analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Pregnant patients in their 2nd trimester.
Exclusion Criteria:
  • Pregnant patients presenting after their 2nd trimester.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rambam health care campus Haifa Israel

Sponsors and Collaborators

  • Rambam Health Care Campus

Investigators

  • Principal Investigator: Roy Lauterbach, MD, Rambam healthcare campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ROY LAUTERBACH MD, Principal Investigator, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT03930290
Other Study ID Numbers:
  • 0567-18-RMB
First Posted:
Apr 29, 2019
Last Update Posted:
Sep 16, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2020