Biobank on Prematurity, Preeclampsia and Other Pregnancy Complications

Study Overview
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Brief Summary
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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.

Detailed Description
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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 ...)

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

Conditions
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Preeclampsia, Preterm Birth, Pregnancy Complications, Fetal Anomalies

Intervention / Treatment
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* Other: Observational


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prediction Group<br>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<br>* 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)<br>|
| PEARL Group<br>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<br>* 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)<br>|
| GAP Group<br>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<br>* 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)<br>|
| PREDICTION 2 Group<br>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<br>* 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)<br>|
| HAUPE Study<br>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<br>* 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)<br>|

What is the study measuring?
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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 |