The Difference Between Elasticity of the Uterine Cervix in Singleton and Twin Pregnancies (DEU)

September 22, 2015 updated by: Rami Aviram, Meir Medical Center
The investigators aim to compare elasticity of the uterine cervix in singleton and twin pregnancies of similar gestational age.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 44 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

20-44 years old pregnant patients

Description

Inclusion Criteria:

  • Low risk singleton and twin pregnancies

Exclusion Criteria:

  • Patients with pregnancy complications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: Rami Aviram, MD, Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

October 27, 2014

First Submitted That Met QC Criteria

November 4, 2014

First Posted (Estimate)

November 5, 2014

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 0152-14-MMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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