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The First United Arab Emirates National Representative Birth Cohort Study

NCT ID: NCT04928898

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Child and Maternal Health

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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United Arab Emirates University

OTHER

Sponsor Role lead

Responsible Party

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Ayesha Salem Al Dhaheri

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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United Arab Emirates University

Al Ain City, Abu Dhabi Emirate, United Arab Emirates

Site Status RECRUITING

Countries

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United Arab Emirates

Facility Contacts

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Ayesha S Al Dhaheri, PhD

Role: primary

Other Identifiers

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UAE-BCS

Identifier Type: -

Identifier Source: org_study_id