Identification of Corticomedullary Differentiation Along Different Stage of Pregnancy

Nephropathy Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02193516
• Other study ID #: MMC1413-0250CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: June 29, 2014
• Last updated: July 15, 2014
• Start date: July 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2014
• Source: Meir Medical Center
• Contact: Efrat Hadi, MD
• Phone: 09-7472871
• Is FDA regulated: No
• Health authority: Israel:Clalit Health services
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 330
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Nephropathy

Locations

Country	Name	City	State
Israel	Meir Hospital	kfar Sava

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CMD presence		A single exam for each participent. The photos will be reviewed within up to 6 month from examination date	No