The Difference Between Elasticity of the Uterine Cervix i... | NCT02283567

Studies
The Difference Between Elasticity of the Uterine Cervix in Singleton and Twin Pregnancies

NCT02283567

Sponsor

Meir Medical Center

Status

Unknown status

Last Update Posted

Sep 23, 2015Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Pregnancy

Interventions

Not provided

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 27, 2014

First Submission Date that Met QC Criteria

Nov 4, 2014

First Posted Date

Nov 5, 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

The investigators aim to compare elasticity of the uterine cervix in singleton and twin pregnancies of similar gestational age.

Detailed Description

Softening of the uterine cervix occurs during pregnancy.There is a possibility that this process occurs earlier in twin versus singleton pregnancies.The softening of the cervix is reflected by the level of its elasticity which can be measured sonoelastographically. A two dimension image of the cervix is obtained in the midsagittal section and the length is noted. A 2nd sonoelastography image is obtained before pressure is applied with the transducer in the area of the internal os and a third sonoelastography image is obtained until no more shortening of the anterior-posterior diameter is observed.Elastography measurements of the internal os are performed using a color map: red (soft), yellow (medium soft), blue (medium hard) and purple (hard) before and after the application of strain.The change between the color maps before and after strain application in singleton pregnancies will be compared to the change in twin pregnancies of similar gestational age.

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

40Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of elasticity levels in singleton and twin pregnancies (Elastographic measurements of the internal os)		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Low risk singleton and twin pregnancies

Exclusion Criteria:

Patients with 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

20-44 years old pregnant patients

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