• BORN Ontario
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• Emerging Programs
• Pregnancy Cohorts
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Our research using observational cohort studies and randomized controlled trials has been vital to answering many important questions and optimizing clinical practices to improve maternal and child health. Data and biospecimens collected over the course of these efforts serves as a rich resource for trainees and professionals in epidemiology, medicine, maternal-fetal-medicine and methodology.

The Ottawa and Kingston (OaK) Birth Cohort
2002-2009

The purpose of this cohort was to:

• collect epidemiologic information and biological specimens prospectively to study exposures or risk factors and their association with adverse pregnancy outcomes;
• serve as a repository of maternal and infant genetic and epidemiologic information by creating the largest maternal and fetal/infant biobank in Canada for use by future investigators.

Pregnant individuals were recruited in the early second trimester of pregnancy. Recruitment occurred in two phases:

Phase I: designed to ascertain the association between folate intake during pregnancy and adverse placenta-mediated pregnancy outcomes

Phase II: designed to determine whether an association existed between thrombophilias and adverse pregnancy outcomes

Maternal blood was collected at the time of enrollment into the cohort between 12 and 20 weeks gestational age. Cord blood was collected from a subset of consenting participants. For more information, click here. 

P4 Study: Plastics and Personal-care Product use in Pregnancy
2009-2010

This study was designed to measure exposure to phthalates throughout pregnancy and in the early post-natal period in a healthy Canadian cohort. Pregnant individuals were recrutied <20 weeks gestation and followed prospectively throughout pregnancy and up to 2-3 months postnatally. Participants completed short questionnaires at each contact throughout the study and biospecimens were collected:

Maternal Urine: every urine void over a 24 hour period between 6 and 19 weeks gestation (once during a weekday, once on a weekend); spot urine void in each the 2nd and 3rd trimesters, and at 2-3 months postpartum.

Infant urine: within the first month of birth and 2-3 months postparum.

Meconium: within the first few days postpartum

Breastmilk and Infant formula: 2-3 months postpartum

For more information on the P4 study:

• Abuckle TE et al. Maternal and early life exposure to phthalates: The Plastics and Personal-care Products use in Pregnancy (P4) study. Sceince of the Total Environment. 2016; 551-552:344-356. doi: 10.1016/j.scitotenv.2016.02.022.
• Fischer M et al. Bisphenol A and phthalate metabolite urinary concentrations: Daily and across pregnancy variability. Journal of Exposure Science & Environmental Epidemiology. 2015; 25: 231-239. Doi: 10.1038/jes.2014.65
• Arbuckle TE et al. Maternal and infant exposure to environmental phenols as measured in multiple biological matrices. Science of the total environment. 2015; 508: 575-584. Doi: 10.1016/j.scitotenv.2014.10.107.

Pre-Conception Cohort Studies
2009-2012

A series of prospective preconception cohort studies, conducted in collaboration with investigators in the Liuyang region of Hunan province in China.

Men and women living in the catchment area of the Liuyang Maternal and Infant Hospital typically attend a pre-marriage health assessment at the time of marriage registration. Couples planning to get pregnant in the next 6 months are recruited from these clinics to participate in the cohort. Couples undergo baseline socio-demographic and cardiometabolic characterization at recruitment and then, when they became pregnant, were followed across the pregnancy up to delivery. To date, over 3000 women have been enrolled, and over 2000 have become pregnant. Study visits to date have been as follows:

Mother: pre-conception, 12-20 weeks’ gestation, 33-36 weeks’ gestation, delivery, 1 year postpartum

Father: pre-conception

Infant: delivery, 1-year postpartum 

The Folic Acid Clinical Trial (FACT)
2011-2015

FACT was a randomised, double blinded, placebo controlled, phase III, international multicentre trial carried out at 70 high risk obstetric referral centres covering diverse populations in Canada, Argentina, Australia, Jamaica, and the United Kingdom.

FACT was designed and conducted to evaluate the effect of daily supplementation with 4.0 mg folic acid beyond the first trimester on the risk of developing pre-eclampsia among pregnant women at high risk for this condition.

Population: Pregnant women between 8 and 16 weeks completed weeks gestation with a confirmed viable fetus and at least one of the following risk factors for pre-eclampsia: pre-existing hypertension, pre-pregnancy diabetes (type 1 or 2), twin pregnancy, history of pre-eclampsia or BMI ≥35 kg/m2.

Intervention: 4.0 mg folic acid taken daily from randomisation until delivery.

Comparison: Placebo taken daily from randomisation until delivery.

Outcomes: Primary outcome was pre-eclampsia; Secondary outcomes included maternal death, severe pre-eclampsia, placental abruption, preterm delivery, premature rupture of membranes, antenatal inpatient length of stay, intrauterine growth restriction, perinatal mortality, spontaneous abortion, stillbirth, neonatal mortality, neonatal morbidity, and length of stay in NICU.

For more information on FACT:

• Wen SW et al. Effect of high dose folic acid supplementation in pregnancy on pre-eclampsia (FACT): double blind, phase III, randomised controlled, international, multicentre trial. BMJ. 2018; 362:k3478. Doi: 10.1136/bmj.k3478
• Wen SW et al. Effect of Folic Acid Supplementation in Pregnancy on Preeclampsia: The Folic Acid Clinical Trial Study. Journal of Pregnancy. 2013. Doi: 10.1155/2013/294312