Clinical trial NCT03113331: The 3D Cohort Study (Design, Develop, Discover)
Official title: 3D Cohort Study: The Integrated Research Network in Perinatology of Quebec and Eastern Ontario
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pregnancy Outcome
Keywords: Intrauterine growth restriction
Preterm birth
Birth defect
Infant growth
Neurodevelopmental outcomes
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: St. Justine's Hospital
name: CHU de Quebec-Universite Laval
First posted: 2017-04-13
Enrollment: 2366
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Able to communicate in French or English

Exclusion Criteria:

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

Primary outcomes:
measure: Intrauterine growth restriction
timeFrame: At delivery
measure: Preterm birth
timeFrame: At delivery
measure: Neurodevelopment - Bayley
timeFrame: When infants are 2 years old
measure: Neurodevelopment - ABAS
timeFrame: When infants are 2 years old
measure: Neurodevelopment - Sensory Profile
timeFrame: When infants are 2 years old
measure: Neurodevelopment - MacArthur-Bates
timeFrame: When infants are 2 years old
measure: Neurodevelopment - M-CHAT
timeFrame: When infants are 2 years old
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: William D Fraser, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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. doi: 10.1002/uog.15959.
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. eCollection 2017.
citation: 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.
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: 10.3945/jn.116.241216. Epub 2017 Apr 19.
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/s41598-017-18531-3.
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 Endocrinol (Lausanne). 2018 Apr 25;9:198. doi: 10.3389/fendo.2018.00198. eCollection 2018.
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 2018 Jun 27.
citation: 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.
citation: 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.
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: 10.1080/02640414.2018.1499391. Epub 2018 Jul 14.
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 beta-Cell Function Linked to Leptin. J Clin Endocrinol Metab. 2018 Oct 1;103(10):3837-3844. doi: 10.1210/jc.2018-00917.
citation: 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.
citation: 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.
citation: 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.