NCT03930290

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

April 25, 2019

Last Update Submit

September 12, 2020

Conditions

Vaginal Prolapse

Outcome Measures

Primary Outcomes (1)

  • Vaginal elasticity

    Vaginal elasticity evaluation by vaginal tactile imaging analysis

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

Study Arms (1)

Pregnant patients

Pregnant patients in their 2nd trimester.

Diagnostic Test: Vaginal tactile imager

Interventions

Vaginal tactile imagerDIAGNOSTIC_TEST

Vaginal elasticity evaluation by vaginal tactile imaging analysis.

Pregnant patients

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Pregnant patients in their 2nd trimester.

You may not qualify if:

  • Pregnant patients presenting after their 2nd trimester.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

MeSH Terms

Conditions

Uterine Prolapse

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Roy Lauterbach, MD

    Rambam healthcare campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2019

First Posted

April 29, 2019

Study Start

August 1, 2019

Primary Completion

July 31, 2020

Study Completion

August 31, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations

IL(1)