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TerminatedNCT03930290Updated Sep 16, 2020

Physiologic Elasticity Changes During Pregnancy and After Labor.

An observational study in Vaginal Prolapse, sponsored by Rambam Health Care Campus. Terminated at 1 site in Israel. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-09-16.

Sponsored by Rambam Health Care Campus · Observational

Why this study was terminated
Difficulty in patient recruiting
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.
02

Conditions studied

  • Vaginal Prolapse
03

In context

Uterine Prolapse

111 studies on the registry are indexed under Uterine Prolapse; 20 are open to participants now.

This study's enrollment of 12 is below the median of 132 across 28 observational studies indexed under Uterine Prolapse.

Browse Uterine Prolapse studies →

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pregnant patients in their 2nd trimester with no regard to previous obstetric history.

Inclusion criteria

  • Pregnant patients in their 2nd trimester.

Exclusion criteria

Exclusion Criteria:

  • Pregnant patients presenting after their 2nd trimester.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (actual)
Patient registry
No

Groups and cohorts

  • Pregnant patients

    Pregnant patients in their 2nd trimester.

    Diagnostic Test: Vaginal tactile imager

Interventions

  • Diagnostic testVaginal tactile imager

    Vaginal elasticity evaluation by vaginal tactile imaging analysis.

06

What researchers measure

Primary outcomes

  1. Vaginal elasticity

    Vaginal elasticity evaluation by vaginal tactile imaging analysis

    Time frame: From the beginning of the 2nd trimester of pregnancy up to 6 weeks postpartum.

07

Study locations

1 site
  • Rambam health care campus
    Haifa, Israel
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03930290
Lead sponsor
Rambam Health Care Campus
Responsible party
ROY LAUTERBACH MD (Principal Investigator, Rambam Health Care Campus) — Principal investigator
First posted
Apr 29, 2019
Start date
Aug 1, 2019
Primary completion
Jul 31, 2020
Completion
Aug 31, 2020
Last update
Sep 16, 2020

Study contacts

Roy Lauterbach, MD
principal investigator · Rambam healthcare campus

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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