Biobank on Prematurity, Preeclampsia and Other Pregnancy Complications
NCT ID: NCT02744365
Last Updated: 2022-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
7845 participants
OBSERVATIONAL
2015-04-30
2028-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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).
Observational
All women of the biobank have provided:
1. blood samples (plasma, serum and Buffy-coat)
2. urine samples
3. demographic and clinical data (maternal age, BMI, smoking status, obstetrical and medical history)
4. mean arterial blood pressure
5. ultrasound examination (datation of pregnancy at recruitment, uterine arteries doppler, placental volume, nuchal translucency in the majority of the cases)
6. 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 :
1. low-risk pregnant women between 11 and 13 6/7 weeks of gestation (controls, N=45)
2. pregnant women with diagnosis of preeclampsia between 20 and 41 6/7 weeks of gestation (cases, N=45)
Observational
All women of the biobank have provided:
1. blood samples (plasma, serum and Buffy-coat)
2. urine samples
3. demographic and clinical data (maternal age, BMI, smoking status, obstetrical and medical history)
4. mean arterial blood pressure
5. ultrasound examination (datation of pregnancy at recruitment, uterine arteries doppler, placental volume, nuchal translucency in the majority of the cases)
6. 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.
Observational
All women of the biobank have provided:
1. blood samples (plasma, serum and Buffy-coat)
2. urine samples
3. demographic and clinical data (maternal age, BMI, smoking status, obstetrical and medical history)
4. mean arterial blood pressure
5. ultrasound examination (datation of pregnancy at recruitment, uterine arteries doppler, placental volume, nuchal translucency in the majority of the cases)
6. 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).
Observational
All women of the biobank have provided:
1. blood samples (plasma, serum and Buffy-coat)
2. urine samples
3. demographic and clinical data (maternal age, BMI, smoking status, obstetrical and medical history)
4. mean arterial blood pressure
5. ultrasound examination (datation of pregnancy at recruitment, uterine arteries doppler, placental volume, nuchal translucency in the majority of the cases)
6. 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)
Observational
All women of the biobank have provided:
1. blood samples (plasma, serum and Buffy-coat)
2. urine samples
3. demographic and clinical data (maternal age, BMI, smoking status, obstetrical and medical history)
4. mean arterial blood pressure
5. ultrasound examination (datation of pregnancy at recruitment, uterine arteries doppler, placental volume, nuchal translucency in the majority of the cases)
6. access to medical record (for pregnancy/delivery outcomes, newborn birthweight, gestational age at delivery)
Interventions
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Observational
All women of the biobank have provided:
1. blood samples (plasma, serum and Buffy-coat)
2. urine samples
3. demographic and clinical data (maternal age, BMI, smoking status, obstetrical and medical history)
4. mean arterial blood pressure
5. ultrasound examination (datation of pregnancy at recruitment, uterine arteries doppler, placental volume, nuchal translucency in the majority of the cases)
6. access to medical record (for pregnancy/delivery outcomes, newborn birthweight, gestational age at delivery)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* negative fetal heart at recruitment
* women not able to provide an informed consent to the study
18 Years
FEMALE
Yes
Sponsors
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CHU de Quebec-Universite Laval
OTHER
Responsible Party
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Emmanuel Bujold
Professor
Principal Investigators
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Emmanuel Bujold, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
CHU de Quebec
Locations
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CHU de Quebec
Québec, , Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2015-2272
Identifier Type: -
Identifier Source: org_study_id
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