Gestational Age and MaturityNCT03456765
Fetal Kidney in Estimation of GA in Pregnancy
An observational study of Gestational Age and Maturity, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
A true estimation of gestational age (GA) plays animportant role in quality of maternity care such asassessment of fetal growth and to schedule the labordate. Any inaccurate estimation may lead to peri-natalmorbidity and mortality due to iatrogenic pre- or post-maturity . Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Age and Maturity
- What is being tested?
- Ultrasound
- How many people
- 350 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2018to 20 Apr 2019
- How long will I take part?
- 2 Months
- 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 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant ladies with no medical disorders with pregnancy between 16 weeks and 40 weeks in a single living fetus
Who may be able to join
- Single fetus.
- pregnant ladies. with no medical disorders
- Fetal kidneys are normally seen
Who cannot join
- Medical disorders with pregnancy
- Renal anomalies
- Renal agesnesis
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Algazeerah
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: Fetal Kidney in Estimation of GA and Maturity
A true estimation of gestational age (GA) plays animportant role in quality of maternity care such asassessment of fetal growth and to schedule the labordate. Any inaccurate estimation may lead to peri-natalmorbidity and mortality due to iatrogenic pre- or post-maturity .
Read the detailed description
Several longitudinal studies have been performed in the western countries concerning sonographic measurement of fetal kidney length. Initially these were done for diagnosis of renal malformation in utero \& later on they were to find out the correlation between the fetal kidney length and the gestational age
- Conditions
- Gestational Age and Maturity
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
US will be made to assess kidneys
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants who will have accurate GA calculated by Kidney parameters
describes the efficiency of kidney parameters to estimate GA
Measured: within 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start12 Mar 2018
- Primary completion15 Apr 2019 (estimated)
- Study completion20 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Age and MaturityStudies of the same condition, open and under way.
- 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
- 350 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kasr El Aini Hospital, National Research Centre, Egypt
- Responsible party
- Principal investigator, Mahmoud Alalfy, Aljazeera Hospital
- Investigators
- Mahmoud Alalfy, Principal investigator, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456765
- Sponsor's protocol ID
- fetal kidney
- Status last verified
- Jan 2019
- First submitted
- 5 Mar 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Kidney in Estimation of GA and Maturity
- ClinicalTrials.gov ID
- NCT03456765
- Acronym / sponsor ID
- fetal kidney
- Conditions
- Gestational Age and Maturity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Kasr El Aini Hospital, National Research Centre, Egypt
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 15 Apr 2019 (estimated)
- Study completion
- 20 Apr 2019 (estimated)
- First posted
- 7 Mar 2018 (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.
A true estimation of gestational age (GA) plays animportant role in quality of maternity care such asassessment of fetal growth and to schedule the labordate. Any inaccurate estimation may lead to peri-natalmorbidity and mortality due to iatrogenic pre- or post-maturity .
Detailed description
Several longitudinal studies have been performed in the western countries concerning sonographic measurement of fetal kidney length. Initially these were done for diagnosis of renal malformation in utero \& later on they were to find out the correlation between the fetal kidney length and the gestational age
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant ladies with no medical disorders with pregnancy between 16 weeks and 40 weeks in a single living fetus
Key inclusion criteria (3 listed)
- Single fetus.
- pregnant ladies. with no medical disorders
- Fetal kidneys are normally seen
Key exclusion criteria (3 listed)
- Medical disorders with pregnancy
- Renal anomalies
- Renal agesnesis
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 |
|---|---|---|
| UltrasoundUS will be made to assess kidneys | Diagnostic test | – |
Primary outcome
The number of participants who will have accurate GA calculated by Kidney parameters
Time frame: within 2 months
describes the efficiency of kidney parameters to estimate GA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
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.
Mahmoud Alalfy principal investigator
Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Age and Maturity, run by Aljazeera Hospital at 1 site in Egypt.
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 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Mahmoud Alalfy (01002611058, mahmoudalalfy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants who will have accurate GA calculated by Kidney parameters (time frame: within 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2019.