Biobank on Prematurity, Preeclampsia and Other Pregnancy Complications

Biobank of Data and of Human Biological Samples on Prematurity, Preeclampsia and Other Pregnancy Complications

The Biobank includes data and biological specimens of women from three original studies: 1) First-trimester Prediction of Preeclampsia (PREDICTION Study, NCT02189148), 2) Pre-Eclampsia And growth Retardation, an evaluative Longitudinal study (PEARL Study, NCT02379832), 3) Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial (NCT02280031) and 4)PREDICTION2: Prediction of Preeclampsia and other Pregnancy Complications Following Combined Iterative Screening.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Complications; Preterm Birth; Preeclampsia; Fetal Anomalies
• Intervention / Treatment: Other: Observational

Detailed Description

This Biobank is comprised of: 1) medical, social, obstetrical and ultrasonographic data, 2) human biological samples (maternal plasma, serum and buffy coat, maternal urine, cord blood) and 3) the results derived from these (biochemical or ultrasonographic markers, genetics, risk calculations ...)

• Study Type: Observational
• Enrollment (Anticipated): 7845

Contacts and Locations

• Study Contact: Name: Emmanuel Bujold, MD, MSc; Phone Number: 47530 418-525-4444; Email: emmanuel.bujold@crchudequebec.ulaval.ca
• Study Contact Backup: Name: Sylvie Tapp, MSc; Phone Number: 46039 418-525-4444; Email: sylvie.tapp@crchudequebec.ulaval.ca

Study Locations

• Canada
  • Quebec, Canada, G1V 4G2
    • Recruiting
    • CHU de Québec
    • Contact: Emmanuel Bujold, MD, MSc; Phone Number: 47530 418-525-4444; Email: emmanuel.bujold@crchudequebec.ulaval.ca
    • Contact: Sylvie Tapp, MSc; Phone Number: 46009 418-525-4444; Email: sylvie.tapp@crchudequebec.ulaval.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

According to each study:

1. Prediction study: Nulliparous women between 11 and 13 6/7 weeks of gestation
2. PEARL study: Nulliparous women between 11 and 13 6/7 weeks of gestation or diagnosed with preeclampsia between 20 and 42 weeks of gestation
3. GAP Study: women with twin pregnancy between 11 and 13 6/7 weeks of gestation
4. Prediction-2 study: Nulliparous women with singleton pregnancy without fetal anomaly/demise between 14 and 15 6/7 weeks of gestation

Description

Inclusion Criteria:

• (specific to each study)

Exclusion Criteria:

• pregnant women <18 years old at recruitment
• negative fetal heart at recruitment
• women not able to provide an informed consent to the study

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prediction Group; The women recruited in the biobank through the Prediction Study (NCT02189148) are low-risk pregnant women between 11 and 13 6/7 weeks of gestation (N=7600 maximum).	Other: Observational; All women of the biobank have provided: blood samples (plasma, serum and Buffy-coat); urine samples; demographic and clinical data (maternal age, BMI, smoking status, obstetrical and medical history); mean arterial blood pressure; ultrasound examination (datation of pregnancy at recruitment, uterine arteries doppler, placental volume, nuchal translucency in the majority of the cases); access to medical record (for pregnancy/delivery outcomes, newborn birthweight, gestational age at delivery)
PEARL Group; The women recruited in the biobank through the PEARL Study (NCT02379832) are : low-risk pregnant women between 11 and 13 6/7 weeks of gestation (controls, N=45); pregnant women with diagnosis of preeclampsia between 20 and 41 6/7 weeks of gestation (cases, N=45)	Other: Observational; All women of the biobank have provided: blood samples (plasma, serum and Buffy-coat); urine samples; demographic and clinical data (maternal age, BMI, smoking status, obstetrical and medical history); mean arterial blood pressure; ultrasound examination (datation of pregnancy at recruitment, uterine arteries doppler, placental volume, nuchal translucency in the majority of the cases); access to medical record (for pregnancy/delivery outcomes, newborn birthweight, gestational age at delivery)
GAP Group; The women recruited in the biobank through the GAP Trial (NCT02280031) are women pregnant with twins between 11 3/7 and 13 6/7 weeks of gestation(N=50 maximum) randomized for placebo or aspirin.	Other: Observational; All women of the biobank have provided: blood samples (plasma, serum and Buffy-coat); urine samples; demographic and clinical data (maternal age, BMI, smoking status, obstetrical and medical history); mean arterial blood pressure; ultrasound examination (datation of pregnancy at recruitment, uterine arteries doppler, placental volume, nuchal translucency in the majority of the cases); access to medical record (for pregnancy/delivery outcomes, newborn birthweight, gestational age at delivery)
PREDICTION 2 Group; The women recruited in the biobank through the Prediction-2 Study (NCT03067298) are nulliparous pregnant women between 14 and 15 6/7 weeks of gestation (N=1000 maximum).	Other: Observational; All women of the biobank have provided: blood samples (plasma, serum and Buffy-coat); urine samples; demographic and clinical data (maternal age, BMI, smoking status, obstetrical and medical history); mean arterial blood pressure; ultrasound examination (datation of pregnancy at recruitment, uterine arteries doppler, placental volume, nuchal translucency in the majority of the cases); access to medical record (for pregnancy/delivery outcomes, newborn birthweight, gestational age at delivery)
HAUPE Study; Women that are at risk of pre-eclampsia and great obstetrical syndroms (elevated maternal age, invitro fertilization, chronic disease) (N=60) and a control group not at risk (N=60)	Other: Observational; All women of the biobank have provided: blood samples (plasma, serum and Buffy-coat); urine samples; demographic and clinical data (maternal age, BMI, smoking status, obstetrical and medical history); mean arterial blood pressure; ultrasound examination (datation of pregnancy at recruitment, uterine arteries doppler, placental volume, nuchal translucency in the majority of the cases); access to medical record (for pregnancy/delivery outcomes, newborn birthweight, gestational age at delivery)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
early onset preeclampsia	Preeclampsia will be defined according to the Canadian Guidelines for Diagnosis, Evaluation, and Management of the Hypertensive Disorders of Pregnancy guidelines, as de novo hypertension with diastolic blood pressure >90 mmHg on two occasions at least four hours apart, after 20 weeks of pregnancy, associated with proteinuria ≥300 mg/24 h or at least '2 +' protein on urine dipstick or an adverse conditions	diagnosed between 20 and 34 weeks of gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe preeclampsia	Severe Preeclampsia will be defined by the presence of at least one of the following adverse condition: 1) systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 110 mmHg after 4 h of bed rest, 2) proteinuria ≥ 5 g/24 h or at least '3 +' protein on urine dipstick, or 3) oliguria < 400 ml/24 h; 4) cerebral or visual disturbances; epigastric pain; pulmonary edema or cyanosis; thrombocytopenia <100,000mm	between 20 and 42 weeks of gestation
Fetal growth restriction	Fetal growth restriction will be defined as a birth weight below the 10th centile (or below the 3rd centile for severe FGR) of Canadian reference growth charts.	between 20 and 42 weeks of gestation
spontaneous preterm birth	sPTB is a birth occuring spontaneously between 20 and 36 6/7 weeks of gestation	between 20 and 36 6/7 weeks of gestation
Fetal aneuploidies	Any fetal chromosome that has an abnormal number of copies. Example: trisomy 13, 18 or 21.	diagnosed during or after pregnancy

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Anticipated): April 1, 2025
• Study Completion (Anticipated): April 1, 2028

Study Registration Dates

• First Submitted: April 15, 2016
• First Submitted That Met QC Criteria: April 15, 2016
• First Posted (Estimate): April 20, 2016

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Obstetric Labor Complications; Obstetric Labor, Premature; Hypertension, Pregnancy-Induced; Congenital Abnormalities; Premature Birth; Pre-Eclampsia; Pregnancy Complications
• Other Study ID Numbers: 2015-2272

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will publish the results linked to the data collected. We will share these data with other groups that are interested in research on preeclampsia and other pregnancy complications.