Gestational Age and Weight ConditionsNCT03732937
Estimation of Gestational Age by TCD
An observational study of Gestational Age and Weight Conditions, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
Different parameters are used to estimate gestational age AC, HC , BPD and FL Read more about this study
- Who is it for?
- Ages 19 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Age and Weight Conditions
- What is being tested?
- Ultrasonography
- How many people
- 700 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Nov 2018to 20 May 2019
- How long will I take part?
- 4 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 19 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant ladies with GA between 16 - 40 weeks
Who may be able to join
- pregnant ladies with GA between 16 - 40 weeks
Who cannot join
- pregnant ladies with GA less than 16 weeks
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Algazeerah and Kasralainy hospital
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: Estimation of Gestational Age by Transcerebellar Diameter in Normal and Abnormal Pregnancy States
- Different parameters are used to estimate gestational age AC, HC , BPD and FL
Read the detailed description
-TCD is one of the parameters ,here we are testing its accuracy in calculating GA
- Conditions
- Gestational Age and Weight Conditions
- Being tested
- Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDiagnostic test
Ultrasonography with biometry and TCD measurement
| Study group | Role | What they receive |
|---|---|---|
| Control group | Pregnant ladies with no medical disorders from 16 weeks till term Receives: Diagnostic Test: Ultrasonography | |
| case group | Pregnant ladies with medical disorders from 16 weeks till term Receives: Diagnostic Test: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants who will be exactly dated by TCD in comparison to LMP
The number of participants who will be exactly dated by TCD in comparison to LMP in weeks
Measured: within 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start16 Nov 2018
- Primary completion1 May 2019 (estimated)
- Study completion20 May 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 Weight ConditionsStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Centre, Egypt
- Responsible party
- Principal investigator, Mahmoud Alalfy, Aljazeera Hospital
- Investigators
- Mahmoud Alalfy, PhD, Principal investigator, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732937
- Sponsor's protocol ID
- cerebellum
- Status last verified
- Jan 2019
- First submitted
- 5 Nov 2018
- Last updated
- 9 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 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Gestational Age by Transcerebellar Diameter in Normal and Abnormal Pregnancy States
- ClinicalTrials.gov ID
- NCT03732937
- Acronym / sponsor ID
- cerebellum
- Conditions
- Gestational Age and Weight Conditions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- National Research Centre, Egypt
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 20 May 2019 (estimated)
- First posted
- 7 Nov 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.
- Different parameters are used to estimate gestational age AC, HC , BPD and FL
Detailed description
-TCD is one of the parameters ,here we are testing its accuracy in calculating GA
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Diagnostic Test: UltrasonographyPregnant ladies with no medical disorders from 16 weeks till term |
| case group | – | Diagnostic Test: UltrasonographyPregnant ladies with medical disorders from 16 weeks till term |
Who may qualify
- Ages
- 19 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant ladies with GA between 16 - 40 weeks
Key inclusion criteria (1 listed)
- pregnant ladies with GA between 16 - 40 weeks
Key exclusion criteria (1 listed)
- pregnant ladies with GA less than 16 weeks
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 |
|---|---|---|
| UltrasonographyUltrasonography with biometry and TCD measurement | Diagnostic test | Control group, case group |
Primary outcome
The number of participants who will be exactly dated by TCD in comparison to LMP
Time frame: within 4 months
The number of participants who will be exactly dated by TCD in comparison to LMP in weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
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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.
Mahmoud Alalfy, PhD 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 Weight Conditions, 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 1 inclusion and 1 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 9 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, PhD (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 be exactly dated by TCD in comparison to LMP (time frame: within 4 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 9 Jan 2019.