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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 20, 2017
Sponsor:
Collaborators:
St. Justine's Hospital
CHU de Quebec-Universite Laval
Information provided by (Responsible Party):
William Fraser, 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.

Condition or disease
Pregnancy Outcome

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.

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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



Primary Outcome Measures :
  1. Intrauterine growth restriction [ Time Frame: At delivery ]
    Birth weight smaller than 10th percentile

  2. Preterm birth [ Time Frame: At delivery ]
    Delivery before 37 weeks of gestation

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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
Maternal: blood, urine, vaginal secretions, nails, cord blood, placenta, hair, saliva Infant: hair, meconium, blood, urine, saliva Father: Blood, urine, saliva


Information from the National Library of Medicine

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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
Study Population
The 3D Cohort Study is structured around a triadic (mother‐partner‐child) framework. The cohort comprises 2366 women recruited in the first trimester of pregnancy (8-14 weeks) who were planning to deliver in a collaborating hospital in the province of Quebec. Women and their partners were recruited between May 25, 2010 and August 30, 2012 at one of nine study centres during routine first‐trimester prenatal visits to study hospitals and infertility clinics.
Criteria

Inclusion Criteria:

  • Able to communicate in French or English

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Locations
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Canada, Quebec
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
Université de Sherbrooke
St. Justine's Hospital
CHU de Quebec-Universite Laval
Investigators
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Principal Investigator: William D Fraser, Dr Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: William Fraser, Professor, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT03113331     History of Changes
Other Study ID Numbers: CRI 88413
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by William Fraser, Université de Sherbrooke:
Intrauterine growth restriction
Preterm birth
Birth defect
Infant growth
Neurodevelopmental outcomes