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

NCT ID: NCT03113331

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2366 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-25

Study Completion Date

2028-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Outcome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Able to communicate in French or English

Exclusion Criteria

* Current intravenous drug use
* Severe illnesses or life threatening conditions
* Multiple gestation pregnancies
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Justine's Hospital

OTHER

Sponsor Role collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role collaborator

Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

William Fraser

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

William D Fraser, Dr

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Sainte-Justine

Montreal, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

Fraser WD, Shapiro GD, Audibert F, Dubois L, Pasquier JC, Julien P, Berard A, Muckle G, Trasler J, Tremblay RE, Abenhaim H, Welt M, Bedard MJ, Bissonnette F, Bujold E, Gagnon R, Michaud JL, Girard I, Moutquin JM, Marc I, Monnier P, Seguin JR, Luo ZC; 3D Study Group. 3D Cohort Study: The Integrated Research Network in Perinatology of Quebec and Eastern Ontario. Paediatr Perinat Epidemiol. 2016 Nov;30(6):623-632. doi: 10.1111/ppe.12320. Epub 2016 Oct 25.

Reference Type RESULT
PMID: 27781295 (View on PubMed)

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.

Reference Type RESULT
PMID: 28145732 (View on PubMed)

Balayla J, Sheehy O, Fraser WD, Seguin JR, Trasler J, Monnier P, MacLeod AA, Simard MN, Muckle G, Berard A; 3D-Study Research Group From the Integrated Research Network in Perinatology of Quebec and Eastern Ontario. Neurodevelopmental Outcomes After Assisted Reproductive Technologies. Obstet Gynecol. 2017 Feb;129(2):265-272. doi: 10.1097/AOG.0000000000001837.

Reference Type RESULT
PMID: 28079770 (View on PubMed)

Shapiro GD, Seguin 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.

Reference Type RESULT
PMID: 28079434 (View on PubMed)

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

Reference Type RESULT
PMID: 26686548 (View on PubMed)

Pamidi S, Marc I, Simoneau G, Lavigne L, Olha A, Benedetti A, Series 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 cohort study. Thorax. 2016 Aug;71(8):719-25. doi: 10.1136/thoraxjnl-2015-208038. Epub 2016 Apr 15.

Reference Type RESULT
PMID: 27084956 (View on PubMed)

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. doi: 10.1002/uog.15959.

Reference Type RESULT
PMID: 27153518 (View on PubMed)

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. eCollection 2017.

Reference Type RESULT
PMID: 28761717 (View on PubMed)

Thebault-Dagher F, Herba CM, Seguin JR, Muckle G, Lupien SJ, Carmant L, Simard MN, Shapiro GD, Fraser WD, Lippe S. Age at first febrile seizure correlates with perinatal maternal emotional symptoms. Epilepsy Res. 2017 Sep;135:95-101. doi: 10.1016/j.eplepsyres.2017.06.001. Epub 2017 Jun 10.

Reference Type RESULT
PMID: 28651086 (View on PubMed)

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: 10.3945/jn.116.241216. Epub 2017 Apr 19.

Reference Type RESULT
PMID: 28424259 (View on PubMed)

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/s41598-017-18531-3.

Reference Type RESULT
PMID: 29311590 (View on PubMed)

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 Endocrinol (Lausanne). 2018 Apr 25;9:198. doi: 10.3389/fendo.2018.00198. eCollection 2018.

Reference Type RESULT
PMID: 29922227 (View on PubMed)

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 2018 Jun 27.

Reference Type RESULT
PMID: 29791775 (View on PubMed)

Dubois L, Diasparra M, Bedard 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/S0007114518001393. Epub 2018 Jun 7.

Reference Type RESULT
PMID: 29875026 (View on PubMed)

Dupont C, Castellanos-Ryan N, Seguin JR, Muckle G, Simard MN, Shapiro GD, Herba CM, Fraser WD, Lippe 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/s41598-018-28165-8.

Reference Type RESULT
PMID: 29959368 (View on PubMed)

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: 10.1080/02640414.2018.1499391. Epub 2018 Jul 14.

Reference Type RESULT
PMID: 30009665 (View on PubMed)

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 beta-Cell Function Linked to Leptin. J Clin Endocrinol Metab. 2018 Oct 1;103(10):3837-3844. doi: 10.1210/jc.2018-00917.

Reference Type RESULT
PMID: 30032199 (View on PubMed)

Guinhouya BC, Bisson M, Dubois L, Series 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: 10.1089/jwh.2017.6892. Epub 2018 Aug 1.

Reference Type RESULT
PMID: 30067134 (View on PubMed)

Choufani S, Turinsky AL, Melamed N, Greenblatt E, Brudno M, Berard 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. 2019 Feb 1;28(3):372-385. doi: 10.1093/hmg/ddy321.

Reference Type RESULT
PMID: 30239726 (View on PubMed)

Dubois L, Diasparra M, Bedard B, Colapinto CK, Fontaine-Bisson B, Morisset AS, Tremblay RE, Fraser WD. Adequacy of nutritional intake from food and supplements in a cohort of pregnant women in Quebec, Canada: the 3D Cohort Study (Design, Develop, Discover). Am J Clin Nutr. 2017 Aug;106(2):541-548. doi: 10.3945/ajcn.117.155499. Epub 2017 Jun 14.

Reference Type DERIVED
PMID: 28615265 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CRI 88413

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Preventing Lack of Iodine During Pregnancy
NCT00379535 TERMINATED PHASE3
Post-Pregnancy Cardio Trial
NCT03313063 COMPLETED
Covid-19 Infection in Pregnancy
NCT04869202 COMPLETED