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Active, Not Recruiting

NCT Number: NCT03113331

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pregnancy Outcome Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Retardation Growth Disorders Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to communicate in French or English

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

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

Registry information

Official study title

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

Acronym: 3D

Important dates

Study start
2010
Primary completion
2015
Study completion
2028
First posted
Apr 13, 2017
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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