The First United Arab Emirates National Representative Birth Cohort Study
- Conditions
- Child and Maternal Health
- Registration Number
- NCT04928898
- Lead Sponsor
- United Arab Emirates University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 250
- 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).
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Child anthropometric assessment (MUAC) 24 months post-natal Weight (kgs), length, head circumference, mid-upper arm circumference
Maternal Weight 24 months post natal Measured in Kilograms
Maternal Dietary Intake 18 months post natal Food frequency questionnaire
Maternal Blood Pressure 3rd Trimester One point during weeks 27 - 42 Measured sphygmomanometer, in millimetres of mercury.
Maternal Physical Activity 24 months post natal International Physical Activity Questionnaire
Child neurodevelopmental assessment 0.5 months post-natal Neonatal Neurodevelopmental Assessment tool
- Secondary Outcome Measures
Name Time Method Maternal hemoglobin 3rd Trimester One point during weeks 27 - 42 Hemoglobin levels measured in grams per deciliter
Maternal Ferritin 3rd Trimester One point during weeks 27 - 42 Serum ferritin measured in nanograms per milliliter
Maternal Vitamin A 3rd Trimester One point during weeks 27 - 42 Serum retinol measured in micrograms of retinol activity equivalent
Maternal lead concentration 3rd Trimester One point during weeks 27 - 42 Serum lead measured in micromole per litre
Maternal Folate 3rd Trimester One point during weeks 27 - 42 Serum folate measured in nanograms per milliliter
Maternal Vitamin B12 3rd Trimester One point during weeks 27 - 42 Serum B12 measured in picogram per millilitre
Maternal zinc concentration 3rd Trimester One point during weeks 27 - 42 Serum zinc measured in micromole per litre
Maternal Vitamin D 3rd Trimester One point during weeks 27 - 42 Serum 25 hydroxyvitamin D measured in nanomole per liter
Trial Locations
- Locations (1)
United Arab Emirates University
🇦🇪Al Ain, Abu Dhabi, United Arab Emirates