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

Pregnancy Outcome Clinical Trial

— 3D  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03113331
• Other study ID #: CRI 88413
• Status: Active, not recruiting
• Start date: May 25, 2010
• Est. completion date: March 2028

Study information

• Verified date: March 2021
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2366
• Est. completion date: March 2028
• Est. primary completion date: February 2015
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to communicate in French or English

Exclusion Criteria:

• Current intravenous drug use

• Severe illnesses or life threatening conditions

• Multiple gestation pregnancies

Related Conditions & MeSH terms

• Pregnancy Outcome

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Université de Sherbrooke	CHU de Quebec-Universite Laval, St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (19)

Balayla J, Sheehy O, Fraser WD, Séguin JR, Trasler J, Monnier P, MacLeod AA, Simard MN, Muckle G, Bérard A; 3D-Study Research Group From the Integrated Research Network in Perinatology of Quebec and Eastern Ontario. Neurodevelopmental Outcomes After Assis — View Citation

Bisson M, Croteau J, Guinhouya BC, Bujold E, Audibert F, Fraser WD, Marc I. Physical activity during pregnancy and infant's birth weight: results from the 3D Birth Cohort. BMJ Open Sport Exerc Med. 2017 Jun 19;3(1):e000242. doi: 10.1136/bmjsem-2017-000242 — View Citation

Bisson M, Tremblay F, Pronovost E, Julien AS, Marc I. Accelerometry to measure physical activity in toddlers: Determination of wear time requirements for a reliable estimate of physical activity. J Sports Sci. 2019 Feb;37(3):298-305. doi: 10.1080/02640414 — View Citation

Choufani S, Turinsky AL, Melamed N, Greenblatt E, Brudno M, Bérard A, Fraser WD, Weksberg R, Trasler J, Monnier P; 3D cohort study group. Impact of assisted reproduction, infertility, sex and paternal factors on the placental DNA methylome. Hum Mol Genet. — View Citation

Dong Y, Luo ZC, Nuyt AM, Audibert F, Wei SQ, Abenhaim HA, Bujold E, Julien P, Huang H, Levy E, Fraser WD; 3D Cohort Study Group. Large-for-Gestational-Age May Be Associated With Lower Fetal Insulin Sensitivity and ß-Cell Function Linked to Leptin. J Clin — View Citation

Du Q, Luo ZC, Nuyt AM, Audibert F, Julien P, Wei SQ, Zhang DL, Fraser W, Levy E. Vitamin A and E Nutritional Status in Relation to Leptin, Adiponectin, IGF-I and IGF-II in Early Life - a Birth Cohort Study. Sci Rep. 2018 Jan 8;8(1):100. doi: 10.1038/s4159 — View Citation

Dubois L, Diasparra M, Bédard B, Colapinto CK, Fontaine-Bisson B, Tremblay RE, Fraser WD. Adequacy of nutritional intake during pregnancy in relation to prepregnancy BMI: results from the 3D Cohort Study. Br J Nutr. 2018 Aug;120(3):335-344. doi: 10.1017/S — View Citation

Dupont C, Castellanos-Ryan N, Séguin JR, Muckle G, Simard MN, Shapiro GD, Herba CM, Fraser WD, Lippé S. The Predictive Value of Head Circumference Growth during the First Year of Life on Early Child Traits. Sci Rep. 2018 Jun 29;8(1):9828. doi: 10.1038/s41 — View Citation

Fraser WD, Shapiro GD, Audibert F, Dubois L, Pasquier JC, Julien P, Bérard A, Muckle G, Trasler J, Tremblay RE, Abenhaim H, Welt M, Bédard MJ, Bissonnette F, Bujold E, Gagnon R, Michaud JL, Girard I, Moutquin JM, Marc I, Monnier P, Séguin JR, Luo ZC; 3D S — View Citation

Guinhouya BC, Bisson M, Dubois L, Sériès F, Kimoff JR, Fraser WD, Marc I. Body Weight Status and Sleep Disturbances During Pregnancy: Does Adherence to Gestational Weight Gain Guidelines Matter? J Womens Health (Larchmt). 2019 Apr;28(4):535-543. doi: 10.1 — View Citation

He H, Nuyt AM, Luo ZC, Audibert F, Dubois L, Wei SQ, Abenhaim HA, Bujold E, Marc I, Julien P, Fraser WD; 3D Study Group. Maternal Circulating Placental Growth Factor and Neonatal Metabolic Health Biomarkers in Small for Gestational Age Infants. Front Endo — View Citation

Lamarre V, Gilbert NL, Rousseau C, Gyorkos TW, Fraser WD. Seroconversion for cytomegalovirus infection in a cohort of pregnant women in Québec, 2010-2013. Epidemiol Infect. 2016 Jun;144(8):1701-9. doi: 10.1017/S0950268815003167. Epub 2015 Dec 21. — View Citation

Morisset AS, Dubois L, Colapinto CK, Luo ZC, Fraser WD. Prepregnancy Body Mass Index as a Significant Predictor of Total Gestational Weight Gain and Birth Weight. Can J Diet Pract Res. 2017 Jun 1;78(2):66-73. doi: 10.3148/cjdpr-2016-035. Epub 2017 Feb 1. — View Citation

Pamidi S, Marc I, Simoneau G, Lavigne L, Olha A, Benedetti A, Sériès F, Fraser W, Audibert F, Bujold E, Gagnon R, Schwartzman K, Kimoff RJ. Maternal sleep-disordered breathing and the risk of delivering small for gestational age infants: a prospective coh — View Citation

Reboul Q, Delabaere A, Luo ZC, Nuyt AM, Wu Y, Chauleur C, Fraser W, Audibert F. Prediction of small-for-gestational-age neonate by third-trimester fetal biometry and impact of ultrasound-delivery interval. Ultrasound Obstet Gynecol. 2017 Mar;49(3):372-378 — View Citation

Shapiro GD, Séguin JR, Muckle G, Monnier P, Fraser WD. Previous pregnancy outcomes and subsequent pregnancy anxiety in a Quebec prospective cohort. J Psychosom Obstet Gynaecol. 2017 Jun;38(2):121-132. doi: 10.1080/0167482X.2016.1271979. Epub 2017 Jan 12. — View Citation

Tabatabaei N, Auger N, Herba CM, Wei S, Allard C, Fink GD, Fraser WD. Maternal Vitamin D Insufficiency Early in Pregnancy Is Associated with Increased Risk of Preterm Birth in Ethnic Minority Women in Canada. J Nutr. 2017 Jun;147(6):1145-1151. doi: 10.394 — View Citation

Tabatabaei N, Eren AM, Barreiro LB, Yotova V, Dumaine A, Allard C, Fraser WD. Vaginal microbiome in early pregnancy and subsequent risk of spontaneous preterm birth: a case-control study. BJOG. 2019 Feb;126(3):349-358. doi: 10.1111/1471-0528.15299. Epub 2 — View Citation

Thébault-Dagher F, Herba CM, Séguin JR, Muckle G, Lupien SJ, Carmant L, Simard MN, Shapiro GD, Fraser WD, Lippé S. Age at first febrile seizure correlates with perinatal maternal emotional symptoms. Epilepsy Res. 2017 Sep;135:95-101. doi: 10.1016/j.epleps — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrauterine growth restriction	Birth weight smaller than 10th percentile	At delivery
Primary	Preterm birth	Delivery before 37 weeks of gestation	At delivery
Primary	Neurodevelopment - Bayley	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
Primary	Neurodevelopment - ABAS	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
Primary	Neurodevelopment - Sensory Profile	Neurodevelopmental assessment of the infant. Test used : Sensory Profile questionnaire. This test was done on 1520 children.	When infants are 2 years old
Primary	Neurodevelopment - MacArthur-Bates	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
Primary	Neurodevelopment - M-CHAT	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