The 3D Cohort Study (Design, Develop, Discover)

3D Cohort Study: The Integrated Research Network in Perinatology of Quebec and Eastern Ontario

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03113331

Acronym

Enrollment

2366

Registered

2017-04-13

Start date

2010-05-25

Completion date

2028-03-31

Last updated

2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Outcome

Keywords

Intrauterine growth restriction, Preterm birth, Birth defect, Infant growth, Neurodevelopmental outcomes

Brief summary

The 3D Cohort Study (Design, Develop, Discover) was established to help bridge knowledge gaps about the links between various adverse exposures during pregnancy with birth outcomes and later health outcomes in children.

Detailed description

The main objective of the 3D study is to create a large pregnancy and birth cohort, allowing for the assessment of the effects of combined prenatal exposure on both birth outcomes and longer-term infant and child health. The specific objectives are to: 1. Determine the effects of pre- and post-natal exposures to environmental contaminants, nutritional factors and psychosocial stress on pregnancy and neurodevelopmental outcomes; 2. Assess the contribution of social, genetic, epigenetic, nutritional and environmental factors to the etiology and outcomes of intrauterine growth restriction (IUGR) and preterm birth; and 3. Assess the effects of assisted reproductive technologies (ART) on indicators of epigenetic modifications, and the relationship between such epigenetic changes and infant neurodevelopmental, cardiovascular, and metabolic outcomes.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Inclusion criteria

* Able to communicate in French or English

Exclusion criteria

* Current intravenous drug use * Severe illnesses or life threatening conditions * Multiple gestation pregnancies

Design outcomes

Primary

Measure	Time frame	Description
Neurodevelopment - ABAS	When infants are 2 years old	Neurodevelopmental assessment of the infant. Test used : Bayley Adaptive Behaviour Questionnaire (ABAS-II). This test was done on 1520 children.
Neurodevelopment - Bayley	When infants are 2 years old	Neurodevelopmental assessment of the infant. Test used : Bayley Scales of Infant and Toddler Development (BSID-III; cognitive scale and motor scale combined). This test was done on 1520 children.
Intrauterine growth restriction	At delivery	Birth weight smaller than 10th percentile
Preterm birth	At delivery	Delivery before 37 weeks of gestation
Neurodevelopment - Sensory Profile	When infants are 2 years old	Neurodevelopmental assessment of the infant. Test used : Sensory Profile questionnaire. This test was done on 1520 children.
Neurodevelopment - MacArthur-Bates	When infants are 2 years old	Neurodevelopmental assessment of the infant. Test used : MacArthur Communicative Development Inventories (CDI; French, English, Spanish and/or Mandarin). This test was done on 1520 children.
Neurodevelopment - M-CHAT	When infants are 2 years old	Neurodevelopmental assessment of the infant. Test used : Modified Checklist of Autism in Toddlers (M-CHAT). This test was done on 1520 children.

Countries

Canada

Outcome results