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

Active, not recruiting

• Conditions: Pregnancy Outcome

• Registration Number: NCT03113331
• Lead Sponsor: Université de Sherbrooke

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.

Study Timeline

• Study Start: 2010-05-25
• Primary Completion: 2015-02
• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-13
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-26
• Last Update Posted: 2021-04-01
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 2366

Inclusion Criteria

• Able to communicate in French or English

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intrauterine growth restriction	At delivery	Birth weight smaller than 10th percentile
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.
Preterm birth	At delivery	Delivery before 37 weeks of gestation
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.
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.

Trial Locations

Locations (1)

CHU Sainte-Justine; 🇨🇦 Montreal, Quebec, Canada