Physiologic Elasticity Changes During Pregnancy and After... | NCT03930290

Studies
Physiologic Elasticity Changes During Pregnancy and After Labor.

NCT03930290

Sponsor

Rambam Health Care Campus

Status

Terminated

Last Update Posted

Sep 16, 2020Actual

Enrollment

12Actual

Phase

Not provided

Conditions

Vaginal Prolapse

Interventions

Vaginal tactile imager

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty in patient recruiting

Expanded Access Info

Start Date

Aug 1, 2019Actual

Primary Completion Date

Jul 31, 2020Actual

Completion Date

Aug 31, 2020Actual

First Submitted Date

Apr 25, 2019

First Submission Date that Met QC Criteria

Apr 25, 2019

First Posted Date

Apr 29, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2020

Last Update Posted Date

Sep 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregnant patients		Pregnant patients in their 2nd trimester.	Diagnostic Test: Vaginal tactile imager

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vaginal tactile imager	Diagnostic Test	Vaginal elasticity evaluation by vaginal tactile imaging analysis.	Pregnant patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant patients in their 2nd trimester.

Exclusion Criteria:

Pregnant patients presenting after their 2nd trimester.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnancy

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roy Lauterbach, MD	Rambam healthcare campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam health care campus		Haifa			Israel

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014596	Uterine Prolapse

Ancestor Terms

ID	Term
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided