Identification of Corticomedullary Differentiation Along Different Stage of Pregnancy

NCT ID: NCT02193516

Last Updated: 2014-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 330 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-06-30

Brief Summary

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.

Conditions

Nephropathy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Meir Hospital

Kfar Saba, , Israel

Countries

Israel

Central Contacts

Efrat Hadi, MD

Role: CONTACT

09-7472871

Facility Contacts

Efrat hadi

Role: primary

Other Identifiers

MMC1413-0250CTIL

Identifier Type: -

Identifier Source: org_study_id