NCT02193516

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 17, 2014

Status Verified

July 1, 2014

Enrollment Period

11 months

First QC Date

June 29, 2014

Last Update Submit

July 15, 2014

Conditions

Nephropathy

Outcome Measures

Primary Outcomes (1)

  • CMD presence

    A single exam for each participent. The photos will be reviewed within up to 6 month from examination date

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pregnant women 14-24 gestational age

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Hospital

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Efrat Hadi, MD

CONTACT

09-7472871

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2014

First Posted

July 17, 2014

Study Start

July 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 17, 2014

Record last verified: 2014-07

Locations

IL(1)