NCT06440499

Brief Summary

To evaluate the role of ultrasound in prenatal diagnosis of congenital anomalies of kidney and urinary system in third trimester of pregnancy. Primay outcomes: To determine incidence of congenital anomalies in kidney and urinary system in Third Timerter by ultrasound.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Status
not yet recruiting

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

May 24, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2025

Completed
Last Updated

June 4, 2024

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

May 24, 2024

Last Update Submit

May 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • To determine sensitivity, spacificy, the +ve PP &-ve P.P of ultrsound screening for renal anomalies.

    1 year

Interventions

USDIAGNOSTIC_TEST

Us

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

pregnant

You may qualify if:

  • Singleton pregnancy.
  • Healthy women Aged between 20 to 40 years old.
  • Third trimester

You may not qualify if:

  • Multiples pregnancies.
  • Maternal D.M or HTN
  • Patients\' refusal to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Al-Hamed MH, Sayer JA, Alsahan N, Tulbah M, Kurdi W, Ambusaidi Q, Ali W, Imtiaz F. Novel loss of function variants in FRAS1 AND FREM2 underlie renal agenesis in consanguineous families. J Nephrol. 2021 Jun;34(3):893-900. doi: 10.1007/s40620-020-00795-0. Epub 2020 Jul 8.

    PMID: 32643034BACKGROUND

Central Study Contacts

m.salah250@yahoo.com screening of congenital anomalies of kidney

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assiut University

Study Record Dates

First Submitted

May 24, 2024

First Posted

June 4, 2024

Study Start

July 1, 2024

Primary Completion

March 5, 2025

Study Completion

April 5, 2025

Last Updated

June 4, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share