Clinical and Sonoelasographic Evaluation of the Elasticit... | NCT02288689

Studies
Clinical and Sonoelasographic Evaluation of the Elasticity of the Uterine Cervix in Pregnant Patients at Term

NCT02288689

Sponsor

Meir Medical Center

Status

Unknown status

Last Update Posted

Sep 23, 2015Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Pregnancy

Interventions

Acuuvix SonoAce UGEO

Countries

Not provided

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 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Nov 2016Estimated

Completion Date

Nov 2016Estimated

First Submitted Date

Oct 26, 2014

First Submission Date that Met QC Criteria

Nov 7, 2014

First Posted Date

Nov 11, 2014Estimated

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 22, 2015

Last Update Posted Date

Sep 23, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

In this study the investigators aim to compare the cervical dilation time in pregnant patients at term who had clinical evaluation of the cervical consistency with patients who had also quantitative measurement of the cervical elasticity in .

Detailed Description

Softening of the uterine cervix in pregnant patients at term is usually evaluated clinically by subjective vaginal manual examination (Bishop's score).One of the variables of the score is cervical consistency which is considered important factor.The cervical consistency is described as soft,medium or stiff.However, the digital assessment of consistency is subjective and less reproducible.The Bishop's score also gives information about expected duration of labor after induction. The consistency of the uterine cervix can also be evaluated objectively sonoelastographically by measuring the cervical elasticity.This is illustrated by a color map, where low stiffness (soft tissue) is indicated in red, middle stiffness is in green and high stiffness (hard tissue) is in blue.In this study we aim to compare the cervical dilation time between the clinical evaluation of the cervical consistency and the quantitative measurement of the cervical elasticity in pregnant patients at term.

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

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acuuvix SonoAce UGEO	Device	Ultrasonographic vaginal examination

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess elasticity of uterine cervix through comparison of sonoelastographic evaluation and manual vaginal examination [Bishop Score] in pregnant patients at term		at time of the manual vaginal examination and participants will be followed for the duration of hospital stay, an expected average of 5 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant patients at term

Exclusion Criteria:

Various pregnancy complications

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Pregnant patients 20-44 years old at term

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rami Aviram, MD	Contact	972544944862		rami.aviram@clalit.org.il

Overall Officials

Name	Affiliation	Role
Rami Aviram, MD	Meir Medical Center	Principal Investigator

Locations

Not provided