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

March 26, 2021 updated by: William Fraser, Université de Sherbrooke

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

2366

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

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • CHU Sainte-Justine

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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 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

Outcome Measure
Measure Description
Time Frame
Intrauterine growth restriction
Time Frame: At delivery
Birth weight smaller than 10th percentile
At delivery
Preterm birth
Time Frame: At delivery
Delivery before 37 weeks of gestation
At delivery
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.
When infants are 2 years old
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.
When infants are 2 years old
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.
When infants are 2 years old
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.
When infants are 2 years old
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.
When infants are 2 years old

Collaborators and Investigators

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

Sponsor

Université de Sherbrooke

Collaborators

CHU de Quebec-Universite Laval
St. Justine's Hospital

Investigators

  • Principal Investigator: William D Fraser, Dr, Centre de recherche du Centre hospitalier Universitaire de Sherbrooke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 25, 2010

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ANTICIPATED)

March 1, 2028

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (ACTUAL)

April 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 26, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRI 88413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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