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Child and Maternal HealthUAE-BCSNCT04928898

The First United Arab Emirates National Representative Birth Cohort Study

An observational study of Child and Maternal Health, run by United Arab Emirates University at 1 site in United Arab Emirates.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In this study, a multidisciplinary team of researchers was established including credible researchers from the UAE, Australia and the United Kingdom to launch the First United Arab Emirates 3-year birth cohort study. Read more about this study

Who is it for?
Ages 16 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Child and Maternal Health
How many people
250 participants
Where
1 siteUnited Arab Emirates
Study dates
1 May 2021to Dec 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 16 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Study population: The study aims to recruit a total of 250 pregnant Emirati females during their first trimester (8 - 12 weeks of gestation) through face-to-face recruitment at OB-GYN clinics in selected health care facilities across the emirates of the UAE. The participants will be provided with both verbal and written information (Participant Information sheet) about the study aims, data collected, and duration of the study. Mothers will provide written consent on behalf of their children to be included in the study. Participants will give consent by signing the study consent form after their agreement and after meeting the following inclusion and exclusion criteria.

Who may be able to join

  • Emirati Nationality
  • Within first trimester of pregnancy (between 8 -12 weeks of gestation)
  • Singleton pregnancy
  • Absence of major illness preconception (Diabetes mellitus, hypertension, kidney disease, cancer, epilepsy, severe psychiatric illness, and other chronic diseases of infections such as autoimmune disorders, human immunodeficiency virus, and hepatitis).

Who cannot join

  • Non-Emirati
  • Unconfirmed viable, intrauterine pregnancy at first obstetric ultrasound during first trimester
  • Twin or multiple gestation pregnancy and a history of multiple gestations
  • History of chronic illness (i.e., T2DM, hypertension, etc.)
  • Previously given birth to babies with malformation, intellectual disability, or inborn errors of metabolism.
  • Experience of a miscarriage before 28 weeks of gestation
  • On significant regular medications, including insulin, anti-hypertensive agents, psychotropic medications, anti-epileptic drugs, steroids, immune-suppressive agents, and chemotherapeutic agents.

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site, 1 recruiting

  • United Arab Emirates University

    Al Ain City, Abu Dhabi Emirate

    Ayesha S Al Dhaheri, PhD, +971 3 7136020, ayesha_aldhaheri@uaeu.ac.ae

    Recruiting

Other trials in United Arab Emirates

About this study

In this study, a multidisciplinary team of researchers was established including credible researchers from the UAE, Australia and the United Kingdom to launch the First United Arab Emirates 3-year birth cohort study. The study aims to recruit 250 pregnant Emirati women within their first trimester, which is defined by the study as from 8 to 12 weeks pregnant, recruited from obstetric and gynaecology clinics in the UAE. Participants will be recruited via face to face interviews and will receive a total of 11 visits with 1 visit in each trimester of pregnancy and 8 visits after delivery. Maternal data collection includes, socio-demographic and lifestyle factors, dietary intake, anthropometric measurements, physical activity, maternal psychological state, and blood samples for biochemical analysis. Post-partum, visits will take place when the child is 0.5, 4, 6, 9, 12, 18, and 24 months old, with data collection including infant anthropometric measurements, young child feeding practices, dietary intake, supplement use and the eating environment at home, as well as all maternal data collection described above, apart from blood samples. Additional data collection for the child includes developmental assessments taking place at three timepoints, 1) within 2 weeks of birth, 2) at 10-14 months and 3) at 22 - 26 months of age. Developmental assessments for the infant include vision, health, neurological examination, neurodevelopmental and sleep assessments.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal Dietary Intake

    24 hour dietary recall

    Measured: 1st Trimester One point during weeks 1 - 13

  2. Maternal Dietary Intake

    24 hour dietary recall

    Measured: 2nd Trimester. One point during Weeks 14 - 26

  3. Maternal Dietary Intake

    24 hour dietary recall

    Measured: 3rd Trimester One point during weeks 27 - 42

  4. Maternal Dietary Intake

    24 hour dietary recall

    Measured: 4 months post natal

  5. Maternal Dietary Intake

    24 hour dietary recall

    Measured: 18 months post natal

  6. Maternal Dietary Intake

    Food frequency questionnaire

    Measured: 1st Trimester - One point during weeks 1 - 13

  7. Maternal Dietary Intake

    Food frequency questionnaire

    Measured: 2nd Trimester. One point during Weeks 14 - 26

  8. Maternal Dietary Intake

    Food frequency questionnaire

    Measured: 3rd Trimester One point during weeks 27 - 42

  9. Maternal Dietary Intake

    Food frequency questionnaire

    Measured: 4 months post natal

  10. Maternal Dietary Intake

    Food frequency questionnaire

    Measured: 18 months post natal

  11. Maternal Weight

    Measured in Kilograms

    Measured: 1st Trimester - One point during weeks 1 - 13

  12. Maternal Weight

    Measured in Kilograms

    Measured: 2nd Trimester. One point during Weeks 14 - 26

  13. Maternal Weight

    Measured in Kilograms

    Measured: 3rd Trimester One point during weeks 27 - 42

  14. Maternal Weight

    Measured in Kilograms

    Measured: 0.5 months post natal

  15. Maternal Weight

    Measured in Kilograms

    Measured: 4 months post natal

  16. Maternal Weight

    Measured in Kilograms

    Measured: 6 months post natal

  17. Maternal Weight

    Measured in Kilograms

    Measured: 9 months post natal

  18. Maternal Weight

    Measured in Kilograms

    Measured: 12 months post natal

  19. Maternal Weight

    Measured in Kilograms

    Measured: 18 months post natal

  20. Maternal Weight

    Measured in Kilograms

    Measured: 24 months post natal

  21. Maternal Blood Pressure

    Measured sphygmomanometer, in millimetres of mercury.

    Measured: 1st Trimester - One point during weeks 1 - 13

  22. Maternal Blood Pressure

    Measured sphygmomanometer, in millimetres of mercury.

    Measured: 2nd Trimester. One point during Weeks 14 - 26

  23. Maternal Blood Pressure

    Measured sphygmomanometer, in millimetres of mercury.

    Measured: 3rd Trimester One point during weeks 27 - 42

  24. Maternal Physical Activity

    International Physical Activity Questionnaire

    Measured: 2nd Trimester. One point during Weeks 14 - 26

  25. Maternal Physical Activity

    International Physical Activity Questionnaire

    Measured: 12 months post natal

  26. Maternal Physical Activity

    International Physical Activity Questionnaire

    Measured: 24 months post natal

  27. Child neurodevelopmental assessment

    INTERGROWTH-21st Neurodevelopment Assessment

    Measured: 24 months post-natal

  28. Child neurodevelopmental assessment

    Oxford Neonatal Neurodevelopmental Assessment tool

    Measured: 12 months post-natal

  29. Child neurodevelopmental assessment

    Neonatal Neurodevelopmental Assessment tool

    Measured: 0.5 months post-natal

  30. Child anthropometric assessment (MUAC)

    Weight (kgs), length, head circumference, mid-upper arm circumference

    Measured: 0.5 months post-natal

  31. Child anthropometric assessment (MUAC)

    Weight (kgs), length, head circumference, mid-upper arm circumference

    Measured: 4 months post-natal

  32. Child anthropometric assessment (MUAC)

    Weight (kgs), length, head circumference, mid-upper arm circumference

    Measured: 6 months post-natal

  33. Child anthropometric assessment (MUAC)

    Weight (kgs), length, head circumference, mid-upper arm circumference

    Measured: 9 months post-natal

  34. Child anthropometric assessment (MUAC)

    Weight (kgs), length, head circumference, mid-upper arm circumference

    Measured: 12 months post-natal

  35. Child anthropometric assessment (MUAC)

    Weight (kgs), length, head circumference, mid-upper arm circumference

    Measured: 18 months post-natal

  36. Child anthropometric assessment (MUAC)

    Weight (kgs), length, head circumference, mid-upper arm circumference

    Measured: 24 months post-natal

Secondary outcomes (15)

  1. Maternal hemoglobin

    Hemoglobin levels measured in grams per deciliter

    Measured: 1st Trimester - One point during weeks 1 - 13

  2. Maternal hemoglobin

    Hemoglobin levels measured in grams per deciliter

    Measured: 3rd Trimester One point during weeks 27 - 42

  3. Maternal Ferritin

    Serum ferritin measured in nanograms per milliliter

    Measured: 1st Trimester - One point during weeks 1 - 13

  4. Maternal Ferritin

    Serum ferritin measured in nanograms per milliliter

    Measured: 3rd Trimester One point during weeks 27 - 42

  5. Maternal Folate

    Serum folate measured in nanograms per milliliter

    Measured: 1st Trimester - One point during weeks 1 - 13

  6. Maternal Folate

    Serum folate measured in nanograms per milliliter

    Measured: 3rd Trimester One point during weeks 27 - 42

  7. Maternal Vitamin D

    Serum 25 hydroxyvitamin D measured in nanomole per liter

    Measured: 1st Trimester - One point during weeks 1 - 13

  8. Maternal Vitamin D

    Serum 25 hydroxyvitamin D measured in nanomole per liter

    Measured: 3rd Trimester One point during weeks 27 - 42

  9. Maternal Vitamin A

    Serum retinol measured in micrograms of retinol activity equivalent

    Measured: 1st Trimester - One point during weeks 1 - 13

  10. Maternal Vitamin A

    Serum retinol measured in micrograms of retinol activity equivalent

    Measured: 3rd Trimester One point during weeks 27 - 42

  11. Maternal Vitamin B12

    Serum B12 measured in picogram per millilitre

    Measured: 1st Trimester - One point during weeks 1 - 13

  12. Maternal Vitamin B12

    Serum B12 measured in picogram per millilitre

    Measured: 3rd Trimester One point during weeks 27 - 42

  13. Maternal zinc concentration

    Serum zinc measured in micromole per litre

    Measured: 1st Trimester - One point during weeks 1 - 13

  14. Maternal zinc concentration

    Serum zinc measured in micromole per litre

    Measured: 3rd Trimester One point during weeks 27 - 42

  15. Maternal lead concentration

    Serum lead measured in micromole per litre

    Measured: 3rd Trimester One point during weeks 27 - 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2021
  2. Study start1 May 2021
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04928898
Sponsor's protocol ID
UAE-BCS
Acronym
UAE-BCS
Status last verified
Nov 2023
First submitted
3 Jun 2021
Last updated
1 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Child and Maternal Health, run by United Arab Emirates University at 1 site in United Arab Emirates.

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 4 inclusion and 7 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 1 Dec 2023. 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 United Arab Emirates. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal Dietary Intake (time frame: 1st Trimester One point during weeks 1 - 13). The study lists 36 primary outcomes in all. 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 NCT04928898.

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 1 Dec 2023.

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