Clinical trial NCT04928898: The First United Arab Emirates National Representative Birth Cohort Study
Official title: The First United Arab Emirates National Representative Birth Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Child and Maternal Health
Lead sponsor: United Arab Emirates University
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 250
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maternal Dietary Intake
timeFrame: 1st Trimester One point during weeks 1 - 13
measure: Maternal Dietary Intake
timeFrame: 2nd Trimester. One point during Weeks 14 - 26
measure: Maternal Dietary Intake
timeFrame: 3rd Trimester One point during weeks 27 - 42
measure: Maternal Dietary Intake
timeFrame: 4 months post natal
measure: Maternal Dietary Intake
timeFrame: 18 months post natal
measure: Maternal Dietary Intake
timeFrame: 1st Trimester - One point during weeks 1 - 13
measure: Maternal Dietary Intake
timeFrame: 2nd Trimester. One point during Weeks 14 - 26
measure: Maternal Dietary Intake
timeFrame: 3rd Trimester One point during weeks 27 - 42
measure: Maternal Dietary Intake
timeFrame: 4 months post natal
measure: Maternal Dietary Intake
timeFrame: 18 months post natal
measure: Maternal Weight
timeFrame: 1st Trimester - One point during weeks 1 - 13
measure: Maternal Weight
timeFrame: 2nd Trimester. One point during Weeks 14 - 26
measure: Maternal Weight
timeFrame: 3rd Trimester One point during weeks 27 - 42
measure: Maternal Weight
timeFrame: 0.5 months post natal
measure: Maternal Weight
timeFrame: 4 months post natal
measure: Maternal Weight
timeFrame: 6 months post natal
measure: Maternal Weight
timeFrame: 9 months post natal
measure: Maternal Weight
timeFrame: 12 months post natal
measure: Maternal Weight
timeFrame: 18 months post natal
measure: Maternal Weight
timeFrame: 24 months post natal
measure: Maternal Blood Pressure
timeFrame: 1st Trimester - One point during weeks 1 - 13
measure: Maternal Blood Pressure
timeFrame: 2nd Trimester. One point during Weeks 14 - 26
measure: Maternal Blood Pressure
timeFrame: 3rd Trimester One point during weeks 27 - 42
measure: Maternal Physical Activity
timeFrame: 2nd Trimester. One point during Weeks 14 - 26
measure: Maternal Physical Activity
timeFrame: 12 months post natal
measure: Maternal Physical Activity
timeFrame: 24 months post natal
measure: Child neurodevelopmental assessment
timeFrame: 24 months post-natal
measure: Child neurodevelopmental assessment
timeFrame: 12 months post-natal
measure: Child neurodevelopmental assessment
timeFrame: 0.5 months post-natal
measure: Child anthropometric assessment (MUAC)
timeFrame: 0.5 months post-natal
measure: Child anthropometric assessment (MUAC)
timeFrame: 4 months post-natal
measure: Child anthropometric assessment (MUAC)
timeFrame: 6 months post-natal
measure: Child anthropometric assessment (MUAC)
timeFrame: 9 months post-natal
measure: Child anthropometric assessment (MUAC)
timeFrame: 12 months post-natal
measure: Child anthropometric assessment (MUAC)
timeFrame: 18 months post-natal
measure: Child anthropometric assessment (MUAC)
timeFrame: 24 months post-natal
Secondary outcomes:
measure: Maternal hemoglobin
timeFrame: 1st Trimester - One point during weeks 1 - 13
measure: Maternal hemoglobin
timeFrame: 3rd Trimester One point during weeks 27 - 42
measure: Maternal Ferritin
timeFrame: 1st Trimester - One point during weeks 1 - 13
measure: Maternal Ferritin
timeFrame: 3rd Trimester One point during weeks 27 - 42
measure: Maternal Folate
timeFrame: 1st Trimester - One point during weeks 1 - 13
measure: Maternal Folate
timeFrame: 3rd Trimester One point during weeks 27 - 42
measure: Maternal Vitamin D
timeFrame: 1st Trimester - One point during weeks 1 - 13
measure: Maternal Vitamin D
timeFrame: 3rd Trimester One point during weeks 27 - 42
measure: Maternal Vitamin A
timeFrame: 1st Trimester - One point during weeks 1 - 13
measure: Maternal Vitamin A
timeFrame: 3rd Trimester One point during weeks 27 - 42
measure: Maternal Vitamin B12
timeFrame: 1st Trimester - One point during weeks 1 - 13
measure: Maternal Vitamin B12
timeFrame: 3rd Trimester One point during weeks 27 - 42
measure: Maternal zinc concentration
timeFrame: 1st Trimester - One point during weeks 1 - 13
measure: Maternal zinc concentration
timeFrame: 3rd Trimester One point during weeks 27 - 42
measure: Maternal lead concentration
timeFrame: 3rd Trimester One point during weeks 27 - 42
Other outcomes:
Locations:
city: Al Ain
country: United Arab Emirates
facility: United Arab Emirates University
state: Abu Dhabi
Study officials:
References: