The 3D Cohort Study (Design, Develop, Discover) (3D)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03113331 |
Recruitment Status :
Active, not recruiting
First Posted : April 13, 2017
Last Update Posted : April 1, 2021
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Condition or disease |
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Pregnancy Outcome |
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:
- Determine the effects of pre- and post-natal exposures to environmental contaminants, nutritional factors and psychosocial stress on pregnancy and neurodevelopmental outcomes;
- 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
- 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 Type : | Observational |
Actual Enrollment : | 2366 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | 3D Cohort Study: The Integrated Research Network in Perinatology of Quebec and Eastern Ontario |
Actual Study Start Date : | May 25, 2010 |
Actual Primary Completion Date : | February 2015 |
Estimated Study Completion Date : | March 2028 |
- Intrauterine growth restriction [ Time Frame: At delivery ]Birth weight smaller than 10th percentile
- Preterm birth [ Time Frame: At delivery ]Delivery before 37 weeks of gestation
- Neurodevelopment - Bayley [ Time Frame: 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 - ABAS [ Time Frame: 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 - Sensory Profile [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Able to communicate in French or English
Exclusion Criteria:
- Current intravenous drug use
- Severe illnesses or life threatening conditions
- Multiple gestation pregnancies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113331
Canada, Quebec | |
CHU Sainte-Justine | |
Montreal, Quebec, Canada, H3T 1C5 |
Principal Investigator: | William D Fraser, Dr | Centre de recherche du Centre hospitalier universitaire de Sherbrooke |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | William Fraser, Professor, Université de Sherbrooke |
ClinicalTrials.gov Identifier: | NCT03113331 |
Other Study ID Numbers: |
CRI 88413 |
First Posted: | April 13, 2017 Key Record Dates |
Last Update Posted: | April 1, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Intrauterine growth restriction Preterm birth Birth defect Infant growth Neurodevelopmental outcomes |