The First United Arab Emirates National Representative Birth Cohort Study

NCT04928898 | Unknown

• 1 other identifier: UAE-BCS
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Child and Maternal Health

Outcome Measures

Primary Outcomes (36)

• 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 Outcomes (15)

• Maternal hemoglobin

  1st Trimester - One point during weeks 1 - 13

• Maternal hemoglobin

  3rd Trimester One point during weeks 27 - 42

• Maternal Ferritin

  1st Trimester - One point during weeks 1 - 13

• Maternal Ferritin

  3rd Trimester One point during weeks 27 - 42

• Maternal Folate

  1st Trimester - One point during weeks 1 - 13

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• United Arab Emirates University: lead

Study Sites (1)

United Arab Emirates University

Al Ain City, Abu Dhabi Emirate, United Arab Emirates

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 16, 2021
• Study Start: May 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)