The First United Arab Emirates National Representative Birth Cohort Study (UAE-BCS)

November 29, 2023 updated by: Ayesha Salem Al Dhaheri, United Arab Emirates University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maternal Dietary Intake
Time Frame: 1st Trimester One point during weeks 1 - 13
24 hour dietary recall
1st Trimester One point during weeks 1 - 13
Maternal Dietary Intake
Time Frame: 2nd Trimester. One point during Weeks 14 - 26
24 hour dietary recall
2nd Trimester. One point during Weeks 14 - 26
Maternal Dietary Intake
Time Frame: 3rd Trimester One point during weeks 27 - 42
24 hour dietary recall
3rd Trimester One point during weeks 27 - 42
Maternal Dietary Intake
Time Frame: 4 months post natal
24 hour dietary recall
4 months post natal
Maternal Dietary Intake
Time Frame: 18 months post natal
24 hour dietary recall
18 months post natal
Maternal Dietary Intake
Time Frame: 1st Trimester - One point during weeks 1 - 13
Food frequency questionnaire
1st Trimester - One point during weeks 1 - 13
Maternal Dietary Intake
Time Frame: 2nd Trimester. One point during Weeks 14 - 26
Food frequency questionnaire
2nd Trimester. One point during Weeks 14 - 26
Maternal Dietary Intake
Time Frame: 3rd Trimester One point during weeks 27 - 42
Food frequency questionnaire
3rd Trimester One point during weeks 27 - 42
Maternal Dietary Intake
Time Frame: 4 months post natal
Food frequency questionnaire
4 months post natal
Maternal Dietary Intake
Time Frame: 18 months post natal
Food frequency questionnaire
18 months post natal
Maternal Weight
Time Frame: 1st Trimester - One point during weeks 1 - 13
Measured in Kilograms
1st Trimester - One point during weeks 1 - 13
Maternal Weight
Time Frame: 2nd Trimester. One point during Weeks 14 - 26
Measured in Kilograms
2nd Trimester. One point during Weeks 14 - 26
Maternal Weight
Time Frame: 3rd Trimester One point during weeks 27 - 42
Measured in Kilograms
3rd Trimester One point during weeks 27 - 42
Maternal Weight
Time Frame: 0.5 months post natal
Measured in Kilograms
0.5 months post natal
Maternal Weight
Time Frame: 4 months post natal
Measured in Kilograms
4 months post natal
Maternal Weight
Time Frame: 6 months post natal
Measured in Kilograms
6 months post natal
Maternal Weight
Time Frame: 9 months post natal
Measured in Kilograms
9 months post natal
Maternal Weight
Time Frame: 12 months post natal
Measured in Kilograms
12 months post natal
Maternal Weight
Time Frame: 18 months post natal
Measured in Kilograms
18 months post natal
Maternal Weight
Time Frame: 24 months post natal
Measured in Kilograms
24 months post natal
Maternal Blood Pressure
Time Frame: 1st Trimester - One point during weeks 1 - 13
Measured sphygmomanometer, in millimetres of mercury.
1st Trimester - One point during weeks 1 - 13
Maternal Blood Pressure
Time Frame: 2nd Trimester. One point during Weeks 14 - 26
Measured sphygmomanometer, in millimetres of mercury.
2nd Trimester. One point during Weeks 14 - 26
Maternal Blood Pressure
Time Frame: 3rd Trimester One point during weeks 27 - 42
Measured sphygmomanometer, in millimetres of mercury.
3rd Trimester One point during weeks 27 - 42
Maternal Physical Activity
Time Frame: 2nd Trimester. One point during Weeks 14 - 26
International Physical Activity Questionnaire
2nd Trimester. One point during Weeks 14 - 26
Maternal Physical Activity
Time Frame: 12 months post natal
International Physical Activity Questionnaire
12 months post natal
Maternal Physical Activity
Time Frame: 24 months post natal
International Physical Activity Questionnaire
24 months post natal
Child neurodevelopmental assessment
Time Frame: 24 months post-natal
INTERGROWTH-21st Neurodevelopment Assessment
24 months post-natal
Child neurodevelopmental assessment
Time Frame: 12 months post-natal
Oxford Neonatal Neurodevelopmental Assessment tool
12 months post-natal
Child neurodevelopmental assessment
Time Frame: 0.5 months post-natal
Neonatal Neurodevelopmental Assessment tool
0.5 months post-natal
Child anthropometric assessment (MUAC)
Time Frame: 0.5 months post-natal
Weight (kgs), length, head circumference, mid-upper arm circumference
0.5 months post-natal
Child anthropometric assessment (MUAC)
Time Frame: 4 months post-natal
Weight (kgs), length, head circumference, mid-upper arm circumference
4 months post-natal
Child anthropometric assessment (MUAC)
Time Frame: 6 months post-natal
Weight (kgs), length, head circumference, mid-upper arm circumference
6 months post-natal
Child anthropometric assessment (MUAC)
Time Frame: 9 months post-natal
Weight (kgs), length, head circumference, mid-upper arm circumference
9 months post-natal
Child anthropometric assessment (MUAC)
Time Frame: 12 months post-natal
Weight (kgs), length, head circumference, mid-upper arm circumference
12 months post-natal
Child anthropometric assessment (MUAC)
Time Frame: 18 months post-natal
Weight (kgs), length, head circumference, mid-upper arm circumference
18 months post-natal
Child anthropometric assessment (MUAC)
Time Frame: 24 months post-natal
Weight (kgs), length, head circumference, mid-upper arm circumference
24 months post-natal

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal hemoglobin
Time Frame: 1st Trimester - One point during weeks 1 - 13
Hemoglobin levels measured in grams per deciliter
1st Trimester - One point during weeks 1 - 13
Maternal hemoglobin
Time Frame: 3rd Trimester One point during weeks 27 - 42
Hemoglobin levels measured in grams per deciliter
3rd Trimester One point during weeks 27 - 42
Maternal Ferritin
Time Frame: 1st Trimester - One point during weeks 1 - 13
Serum ferritin measured in nanograms per milliliter
1st Trimester - One point during weeks 1 - 13
Maternal Ferritin
Time Frame: 3rd Trimester One point during weeks 27 - 42
Serum ferritin measured in nanograms per milliliter
3rd Trimester One point during weeks 27 - 42
Maternal Folate
Time Frame: 1st Trimester - One point during weeks 1 - 13
Serum folate measured in nanograms per milliliter
1st Trimester - One point during weeks 1 - 13
Maternal Folate
Time Frame: 3rd Trimester One point during weeks 27 - 42
Serum folate measured in nanograms per milliliter
3rd Trimester One point during weeks 27 - 42
Maternal Vitamin D
Time Frame: 1st Trimester - One point during weeks 1 - 13
Serum 25 hydroxyvitamin D measured in nanomole per liter
1st Trimester - One point during weeks 1 - 13
Maternal Vitamin D
Time Frame: 3rd Trimester One point during weeks 27 - 42
Serum 25 hydroxyvitamin D measured in nanomole per liter
3rd Trimester One point during weeks 27 - 42
Maternal Vitamin A
Time Frame: 1st Trimester - One point during weeks 1 - 13
Serum retinol measured in micrograms of retinol activity equivalent
1st Trimester - One point during weeks 1 - 13
Maternal Vitamin A
Time Frame: 3rd Trimester One point during weeks 27 - 42
Serum retinol measured in micrograms of retinol activity equivalent
3rd Trimester One point during weeks 27 - 42
Maternal Vitamin B12
Time Frame: 1st Trimester - One point during weeks 1 - 13
Serum B12 measured in picogram per millilitre
1st Trimester - One point during weeks 1 - 13
Maternal Vitamin B12
Time Frame: 3rd Trimester One point during weeks 27 - 42
Serum B12 measured in picogram per millilitre
3rd Trimester One point during weeks 27 - 42
Maternal zinc concentration
Time Frame: 1st Trimester - One point during weeks 1 - 13
Serum zinc measured in micromole per litre
1st Trimester - One point during weeks 1 - 13
Maternal zinc concentration
Time Frame: 3rd Trimester One point during weeks 27 - 42
Serum zinc measured in micromole per litre
3rd Trimester One point during weeks 27 - 42
Maternal lead concentration
Time Frame: 3rd Trimester One point during weeks 27 - 42
Serum lead measured in micromole per litre
3rd Trimester One point during weeks 27 - 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
United Arab Emirates University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UAE-BCS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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