NCT03113331

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,366

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started May 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
May 2010Mar 2028

Study Start

First participant enrolled

May 25, 2010

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
10.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Expected
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

4.7 years

First QC Date

April 10, 2017

Last Update Submit

March 26, 2021

Conditions

Pregnancy Outcome

Keywords

Intrauterine growth restrictionPreterm birthBirth defectInfant growthNeurodevelopmental outcomes

Outcome Measures

Primary Outcomes (7)

  • Intrauterine growth restriction

    Birth weight smaller than 10th percentile

    At delivery

  • Preterm birth

    Delivery before 37 weeks of gestation

    At delivery

  • 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

  • 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

  • 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

  • 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

  • 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

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Able to communicate in French or English

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (20)

  • 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.

    PMID: 27781295RESULT

  • 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.

    PMID: 28145732RESULT

  • 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.

    PMID: 28079770RESULT

  • 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.

    PMID: 28079434RESULT

  • 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.

    PMID: 26686548RESULT

  • 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.

    PMID: 27084956RESULT

  • 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.

    PMID: 27153518RESULT

  • 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.

    PMID: 28761717RESULT

  • 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.

    PMID: 28651086RESULT

  • 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.

    PMID: 28424259RESULT

  • 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.

    PMID: 29311590RESULT

  • 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.

    PMID: 29922227RESULT

  • 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.

    PMID: 29791775RESULT

  • 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.

    PMID: 29875026RESULT

  • 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.

    PMID: 29959368RESULT

  • 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.

    PMID: 30009665RESULT

  • 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.

    PMID: 30032199RESULT

  • 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.

    PMID: 30067134RESULT

  • 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.

    PMID: 30239726RESULT

  • 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.

    PMID: 28615265DERIVED

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

MeSH Terms

Conditions

Fetal Growth RetardationPremature BirthCongenital Abnormalities

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsObstetric Labor, PrematureObstetric Labor Complications

Study Officials

  • William D Fraser, Dr

    Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 13, 2017

Study Start

May 25, 2010

Primary Completion

February 1, 2015

Study Completion (Estimated)

March 1, 2028

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations

CA(1)