The First United Arab Emirates National Representative Birth Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Maternal Weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Maternal Weight
时间窗: 24 months post natal
Measured in Kilograms
Child anthropometric assessment (MUAC)
时间窗: 24 months post-natal
Weight (kgs), length, head circumference, mid-upper arm circumference
Maternal Dietary Intake
时间窗: 18 months post natal
Food frequency questionnaire
Maternal Blood Pressure
时间窗: 3rd Trimester One point during weeks 27 - 42
Measured sphygmomanometer, in millimetres of mercury.
Maternal Physical Activity
时间窗: 24 months post natal
International Physical Activity Questionnaire
Child neurodevelopmental assessment
时间窗: 0.5 months post-natal
Neonatal Neurodevelopmental Assessment tool
次要结局
- Maternal hemoglobin(3rd Trimester One point during weeks 27 - 42)
- Maternal Ferritin(3rd Trimester One point during weeks 27 - 42)
- Maternal Vitamin A(3rd Trimester One point during weeks 27 - 42)
- Maternal lead concentration(3rd Trimester One point during weeks 27 - 42)
- Maternal Folate(3rd Trimester One point during weeks 27 - 42)
- Maternal Vitamin B12(3rd Trimester One point during weeks 27 - 42)
- Maternal zinc concentration(3rd Trimester One point during weeks 27 - 42)
- Maternal Vitamin D(3rd Trimester One point during weeks 27 - 42)
研究者
Ayesha Salem Al Dhaheri
Professor
United Arab Emirates University