Identification of Corticomedullary Differentiation Along Different Stage of Pregnancy

July 15, 2014 updated by: Meir Medical Center
Corticomedullary differentiation (CMD) abnormality (absent/reversed) is a parameter that can indicate possible nephropathy. The evolution of CMD across gestation had not been well established. Devrendt et al demonstrated the presence of CMD in all fetuses older then 20 weeks. In our study we would like to determine the exact timing of it's sonographic visualisation. This is a prospective study recruiting women between 14-24 week gestation during routine ultrasound screening. A midsagittal image of each kidney will be taken by a single sonographer and examined for the presence of the CMD by two other sonographers blinded to gestational age.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

330

Contacts and Locations

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

Study Locations

  • Israel
      • kfar Sava, Israel
        • Meir Hospital

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

pregnant women 14-24 gestational age

Description

Inclusion Criteria:

  • pregnant women 14-24 weeks
  • singleton pregnancy
  • Appropriate for gestational age fetuses
  • well dated pregnancy

Exclusion Criteria:

  • family history of renal disease
  • small /large for gestational age fetuses
  • known structural anomalies
  • unknown dating

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

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CMD presence
Time Frame: A single exam for each participent. The photos will be reviewed within up to 6 month from examination date
A single exam for each participent. The photos will be reviewed within up to 6 month from examination date

Collaborators and Investigators

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

Sponsor

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

July 1, 2014

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

June 29, 2014

First Submitted That Met QC Criteria

July 15, 2014

First Posted (Estimate)

July 17, 2014

Study Record Updates

Last Update Posted (Estimate)

July 17, 2014

Last Update Submitted That Met QC Criteria

July 15, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC1413-0250CTIL

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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