UAE-BCS: The First United Arab Emirates National Representative Birth Cohort Study

• Sponsor: United Arab Emirates University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04928898
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Anticipated Duration (Months): 19
• Patients Per Site Per Month: 13.1

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Child and Maternal Health

Study Design

• Study Type: Observational
• Anticipated Enrollment: 250 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The First United Arab Emirates National Representative Birth Cohort Study
• Actual Study Start Date: May 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Outcome Measures

Primary Outcome Measures

1. Maternal Dietary Intake [1st Trimester One point during weeks 1 - 13]

   24 hour dietary recall

2. Maternal Dietary Intake [2nd Trimester. One point during Weeks 14 - 26]

   24 hour dietary recall

3. Maternal Dietary Intake [3rd Trimester One point during weeks 27 - 42]

   24 hour dietary recall

4. Maternal Dietary Intake [4 months post natal]

   24 hour dietary recall

5. Maternal Dietary Intake [18 months post natal]

   24 hour dietary recall

6. Maternal Dietary Intake [1st Trimester - One point during weeks 1 - 13]

   Food frequency questionnaire

7. Maternal Dietary Intake [2nd Trimester. One point during Weeks 14 - 26]

   Food frequency questionnaire

8. Maternal Dietary Intake [3rd Trimester One point during weeks 27 - 42]

   Food frequency questionnaire

9. Maternal Dietary Intake [4 months post natal]

   Food frequency questionnaire

10. Maternal Dietary Intake [18 months post natal]

    Food frequency questionnaire

11. Maternal Weight [1st Trimester - One point during weeks 1 - 13]

    Measured in Kilograms

12. Maternal Weight [2nd Trimester. One point during Weeks 14 - 26]

    Measured in Kilograms

13. Maternal Weight [3rd Trimester One point during weeks 27 - 42]

    Measured in Kilograms

14. Maternal Weight [0.5 months post natal]

    Measured in Kilograms

15. Maternal Weight [4 months post natal]

    Measured in Kilograms

16. Maternal Weight [6 months post natal]

    Measured in Kilograms

17. Maternal Weight [9 months post natal]

    Measured in Kilograms

18. Maternal Weight [12 months post natal]

    Measured in Kilograms

19. Maternal Weight [18 months post natal]

    Measured in Kilograms

20. Maternal Weight [24 months post natal]

    Measured in Kilograms

21. Maternal Blood Pressure [1st Trimester - One point during weeks 1 - 13]

    Measured sphygmomanometer, in millimetres of mercury.

22. Maternal Blood Pressure [2nd Trimester. One point during Weeks 14 - 26]

    Measured sphygmomanometer, in millimetres of mercury.

23. Maternal Blood Pressure [3rd Trimester One point during weeks 27 - 42]

    Measured sphygmomanometer, in millimetres of mercury.

24. Maternal Physical Activity [2nd Trimester. One point during Weeks 14 - 26]

    International Physical Activity Questionnaire

25. Maternal Physical Activity [12 months post natal]

    International Physical Activity Questionnaire

26. Maternal Physical Activity [24 months post natal]

    International Physical Activity Questionnaire

27. Child neurodevelopmental assessment [24 months post-natal]

    INTERGROWTH-21st Neurodevelopment Assessment

28. Child neurodevelopmental assessment [12 months post-natal]

    Oxford Neonatal Neurodevelopmental Assessment tool

29. Child neurodevelopmental assessment [0.5 months post-natal]

    Neonatal Neurodevelopmental Assessment tool

30. Child anthropometric assessment (MUAC) [0.5 months post-natal]

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

31. Child anthropometric assessment (MUAC) [4 months post-natal]

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

32. Child anthropometric assessment (MUAC) [6 months post-natal]

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

33. Child anthropometric assessment (MUAC) [9 months post-natal]

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

34. Child anthropometric assessment (MUAC) [12 months post-natal]

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

35. Child anthropometric assessment (MUAC) [18 months post-natal]

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

36. Child anthropometric assessment (MUAC) [24 months post-natal]

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

Secondary Outcome Measures

1. Maternal hemoglobin [1st Trimester - One point during weeks 1 - 13]

   Hemoglobin levels measured in grams per deciliter

2. Maternal hemoglobin [3rd Trimester One point during weeks 27 - 42]

   Hemoglobin levels measured in grams per deciliter

3. Maternal Ferritin [1st Trimester - One point during weeks 1 - 13]

   Serum ferritin measured in nanograms per milliliter

4. Maternal Ferritin [3rd Trimester One point during weeks 27 - 42]

   Serum ferritin measured in nanograms per milliliter

5. Maternal Folate [1st Trimester - One point during weeks 1 - 13]

   Serum folate measured in nanograms per milliliter

6. Maternal Folate [3rd Trimester One point during weeks 27 - 42]

   Serum folate measured in nanograms per milliliter

7. Maternal Vitamin D [1st Trimester - One point during weeks 1 - 13]

   Serum 25 hydroxyvitamin D measured in nanomole per liter

8. Maternal Vitamin D [3rd Trimester One point during weeks 27 - 42]

   Serum 25 hydroxyvitamin D measured in nanomole per liter

9. Maternal Vitamin A [1st Trimester - One point during weeks 1 - 13]

   Serum retinol measured in micrograms of retinol activity equivalent

10. Maternal Vitamin A [3rd Trimester One point during weeks 27 - 42]

    Serum retinol measured in micrograms of retinol activity equivalent

11. Maternal Vitamin B12 [1st Trimester - One point during weeks 1 - 13]

    Serum B12 measured in picogram per millilitre

12. Maternal Vitamin B12 [3rd Trimester One point during weeks 27 - 42]

    Serum B12 measured in picogram per millilitre

13. Maternal zinc concentration [1st Trimester - One point during weeks 1 - 13]

    Serum zinc measured in micromole per litre

14. Maternal zinc concentration [3rd Trimester One point during weeks 27 - 42]

    Serum zinc measured in micromole per litre

15. Maternal lead concentration [3rd Trimester One point during weeks 27 - 42]

    Serum lead measured in micromole per litre

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	United Arab Emirates University	Al Ain	Abu Dhabi	United Arab Emirates

Sponsors and Collaborators

• United Arab Emirates University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ayesha Salem Al Dhaheri, Professor, United Arab Emirates University
• ClinicalTrials.gov Identifier: NCT04928898
• Other Study ID Numbers: UAE-BCS
• First Posted: Jun 16, 2021
• Last Update Posted: Jun 16, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 16, 2021