Kidney Congenital AnomaliesNCT06440499
Screening of Congenital Anomalies of Kidney
An observational study of Kidney Congenital Anomalies, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Kidney Congenital Anomalies
- What is being tested?
- US
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 5 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: pregnant
Who may be able to join
- • Singleton pregnancy.
- Healthy women Aged between 20 to 40 years old.
- Third trimester
Who cannot join
- • Multiples pregnancies.
- Maternal D.M or HTN
- Patients\' refusal to participate.
Trial locations and contacts
No sites are listed yet.
m.salah250@yahoo.com screening of congenital anomalies of kidney contact
About this study
Official title: Prenatal Ultrasonographic Screening of Congenital Anomalies of Kidney and Urinary Tract During the Third Trimester of Pregnancy
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.
- Conditions
- Kidney Congenital Anomalies
- Being tested
- US
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USDiagnostic test
Us
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine sensitivity, spacificy, the +ve PP &-ve P.P of ultrsound screening for renal anomalies.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion5 Mar 2025 (estimated)
- Study completion5 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Congenital AnomaliesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440499
- Sponsor's protocol ID
- congenital anomalies of kidney
- Status last verified
- May 2024
- First submitted
- 24 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32643034
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Ultrasonographic Screening of Congenital Anomalies of Kidney and Urinary Tract During the Third Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT06440499
- Acronym / sponsor ID
- congenital anomalies of kidney
- Conditions
- Kidney Congenital Anomalies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 5 Mar 2025 (estimated)
- Study completion
- 5 Apr 2025 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pregnant
Key inclusion criteria (3 listed)
- • Singleton pregnancy.
Key exclusion criteria (3 listed)
- • Multiples pregnancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| USUs | Diagnostic test | – |
Primary outcome
To determine sensitivity, spacificy, the +ve PP &-ve P.P of ultrsound screening for renal anomalies.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Background: PubMed 32643034Al-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
m.salah250@yahoo.com screening of congenital anomalies of kidney contact
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Congenital Anomalies, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact m.salah250@yahoo.com screening of congenital anomalies of kidney (201065574768, m.salah250@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine sensitivity, spacificy, the +ve PP &-ve P.P of ultrsound screening for renal anomalies. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06440499, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.