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

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.

Study Overview

• Status: Recruiting
• Conditions: Child and Maternal Health

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• United Arab Emirates
  • Abu Dhabi
    • Al Ain, Abu Dhabi, United Arab Emirates
      • Recruiting
      • United Arab Emirates University
      • Contact: Ayesha S Al Dhaheri, PhD; Phone Number: +971 3 7136020; Email: ayesha_aldhaheri@uaeu.ac.ae

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Dietary Intake	24 hour dietary recall	1st Trimester One point during weeks 1 - 13
Maternal Dietary Intake	24 hour dietary recall	2nd Trimester. One point during Weeks 14 - 26
Maternal Dietary Intake	24 hour dietary recall	3rd Trimester One point during weeks 27 - 42
Maternal Dietary Intake	24 hour dietary recall	4 months post natal
Maternal Dietary Intake	24 hour dietary recall	18 months post natal
Maternal Dietary Intake	Food frequency questionnaire	1st Trimester - One point during weeks 1 - 13
Maternal Dietary Intake	Food frequency questionnaire	2nd Trimester. One point during Weeks 14 - 26
Maternal Dietary Intake	Food frequency questionnaire	3rd Trimester One point during weeks 27 - 42
Maternal Dietary Intake	Food frequency questionnaire	4 months post natal
Maternal Dietary Intake	Food frequency questionnaire	18 months post natal
Maternal Weight	Measured in Kilograms	1st Trimester - One point during weeks 1 - 13
Maternal Weight	Measured in Kilograms	2nd Trimester. One point during Weeks 14 - 26
Maternal Weight	Measured in Kilograms	3rd Trimester One point during weeks 27 - 42
Maternal Weight	Measured in Kilograms	0.5 months post natal
Maternal Weight	Measured in Kilograms	4 months post natal
Maternal Weight	Measured in Kilograms	6 months post natal
Maternal Weight	Measured in Kilograms	9 months post natal
Maternal Weight	Measured in Kilograms	12 months post natal
Maternal Weight	Measured in Kilograms	18 months post natal
Maternal Weight	Measured in Kilograms	24 months post natal
Maternal Blood Pressure	Measured sphygmomanometer, in millimetres of mercury.	1st Trimester - One point during weeks 1 - 13
Maternal Blood Pressure	Measured sphygmomanometer, in millimetres of mercury.	2nd Trimester. One point during Weeks 14 - 26
Maternal Blood Pressure	Measured sphygmomanometer, in millimetres of mercury.	3rd Trimester One point during weeks 27 - 42
Maternal Physical Activity	International Physical Activity Questionnaire	2nd Trimester. One point during Weeks 14 - 26
Maternal Physical Activity	International Physical Activity Questionnaire	12 months post natal
Maternal Physical Activity	International Physical Activity Questionnaire	24 months post natal
Child neurodevelopmental assessment	INTERGROWTH-21st Neurodevelopment Assessment	24 months post-natal
Child neurodevelopmental assessment	Oxford Neonatal Neurodevelopmental Assessment tool	12 months post-natal
Child neurodevelopmental assessment	Neonatal Neurodevelopmental Assessment tool	0.5 months post-natal
Child anthropometric assessment (MUAC)	Weight (kgs), length, head circumference, mid-upper arm circumference	0.5 months post-natal
Child anthropometric assessment (MUAC)	Weight (kgs), length, head circumference, mid-upper arm circumference	4 months post-natal
Child anthropometric assessment (MUAC)	Weight (kgs), length, head circumference, mid-upper arm circumference	6 months post-natal
Child anthropometric assessment (MUAC)	Weight (kgs), length, head circumference, mid-upper arm circumference	9 months post-natal
Child anthropometric assessment (MUAC)	Weight (kgs), length, head circumference, mid-upper arm circumference	12 months post-natal
Child anthropometric assessment (MUAC)	Weight (kgs), length, head circumference, mid-upper arm circumference	18 months post-natal
Child anthropometric assessment (MUAC)	Weight (kgs), length, head circumference, mid-upper arm circumference	24 months post-natal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal hemoglobin	Hemoglobin levels measured in grams per deciliter	1st Trimester - One point during weeks 1 - 13
Maternal hemoglobin	Hemoglobin levels measured in grams per deciliter	3rd Trimester One point during weeks 27 - 42
Maternal Ferritin	Serum ferritin measured in nanograms per milliliter	1st Trimester - One point during weeks 1 - 13
Maternal Ferritin	Serum ferritin measured in nanograms per milliliter	3rd Trimester One point during weeks 27 - 42
Maternal Folate	Serum folate measured in nanograms per milliliter	1st Trimester - One point during weeks 1 - 13
Maternal Folate	Serum folate measured in nanograms per milliliter	3rd Trimester One point during weeks 27 - 42
Maternal Vitamin D	Serum 25 hydroxyvitamin D measured in nanomole per liter	1st Trimester - One point during weeks 1 - 13
Maternal Vitamin D	Serum 25 hydroxyvitamin D measured in nanomole per liter	3rd Trimester One point during weeks 27 - 42
Maternal Vitamin A	Serum retinol measured in micrograms of retinol activity equivalent	1st Trimester - One point during weeks 1 - 13
Maternal Vitamin A	Serum retinol measured in micrograms of retinol activity equivalent	3rd Trimester One point during weeks 27 - 42
Maternal Vitamin B12	Serum B12 measured in picogram per millilitre	1st Trimester - One point during weeks 1 - 13
Maternal Vitamin B12	Serum B12 measured in picogram per millilitre	3rd Trimester One point during weeks 27 - 42
Maternal zinc concentration	Serum zinc measured in micromole per litre	1st Trimester - One point during weeks 1 - 13
Maternal zinc concentration	Serum zinc measured in micromole per litre	3rd Trimester One point during weeks 27 - 42
Maternal lead concentration	Serum lead measured in micromole per litre	3rd Trimester One point during weeks 27 - 42

Collaborators and Investigators

• Sponsor: United Arab Emirates University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: UAE-BCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No