DiabetesNCT04149548
Placental Assessment in Diabetic Mothers
An observational study of Diabetes, run by Aljazeera Hospital at 2 sites in Egypt.
Trial summary
Diabetes mellitus is one of the major heath problems Read more about this study
- Who is it for?
- Ages 20 to 42 years, women only
- Conditions the study is for
- Diabetes
- What is being tested?
- ultrasound
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 5 Nov 2019to 1 Dec 2020
- 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 20 to 42 years
- Women only
- No healthy volunteers
- Adult
Study population: Diabetic and non diabetic pregnanrt women attending for ANC
Who may be able to join
- in control group A non diabetic pregnant women
Who cannot join
- Diabetic pregnant women
- And the reverse in group B
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Algazeerah and Kasralainy hospital
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
- Recruiting
Algazeerah
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: Placental Assessment in Early and Late Pregnancy in Diabetic Women
Diabetes mellitus is one of the major heath problems
Read the detailed description
Maternal and fetal effects are edpected to be more than in diabetic mothers
- Conditions
- Diabetes
- Being tested
- ultrasound
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDiagnostic test
Obstetric ultrasound to pregnant women
| Study group | Role | What they receive |
|---|---|---|
| pregnant diabetic women | Fetal Ultrasound to diabetic pregnant women Receives: Diagnostic Test: ultrasound | |
| non diabetic pregnant women | Fetal ultrasound to non diabetic pregnant women Receives: Diagnostic Test: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of diabetic fetuses who will have undesirable effects
Number of fetuses with macrosomia and other diabetes effects
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start5 Nov 2019
- Primary completion6 Nov 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Alalfy, Aljazeera Hospital
- Investigators
- Mahmoud Alalfy, PhD, Principal investigator, Algezeera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149548
- Sponsor's protocol ID
- Diabetes mellitus
- Status last verified
- Feb 2020
- First submitted
- 31 Oct 2019
- Last updated
- 6 Feb 2020
- 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 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placental Assessment in Early and Late Pregnancy in Diabetic Women
- ClinicalTrials.gov ID
- NCT04149548
- Acronym / sponsor ID
- Diabetes mellitus
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 6 Nov 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 4 Nov 2019 (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.
Diabetes mellitus is one of the major heath problems
Detailed description
Maternal and fetal effects are edpected to be more than in diabetic mothers
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnant diabetic women | – | Diagnostic Test: ultrasoundFetal Ultrasound to diabetic pregnant women |
| non diabetic pregnant women | – | Diagnostic Test: ultrasoundFetal ultrasound to non diabetic pregnant women |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Diabetic and non diabetic pregnanrt women attending for ANC
Key inclusion criteria (1 listed)
- in control group A non diabetic pregnant women
Key exclusion criteria (2 listed)
- Diabetic pregnant women
- And the reverse in group B
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 |
|---|---|---|
| ultrasoundObstetric ultrasound to pregnant women | Diagnostic test | non diabetic pregnant women, pregnant diabetic women |
Primary outcome
The number of diabetic fetuses who will have undesirable effects
Time frame: within 6 months
Number of fetuses with macrosomia and other diabetes effects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
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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
Algezeera
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Aljazeera Hospital at 2 sites 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 2 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 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 diabetic fetuses who will have undesirable effects (time frame: within 6 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 6 Feb 2020.