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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.
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 ...)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| PEARL Group | The women recruited in the biobank through the PEARL Study (NCT02379832) are :
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| 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. |
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| 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). |
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| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | All women of the biobank have provided:
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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According to each study:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emmanuel Bujold, MD, MSc | Contact | 418-525-4444 | 47530 | emmanuel.bujold@crchudequebec.ulaval.ca |
| Sylvie Tapp, MSc | Contact | 418-525-4444 | 46039 | sylvie.tapp@crchudequebec.ulaval.ca |
| Name | Affiliation | Role |
|---|---|---|
| Emmanuel Bujold, MD, MSc | CHU de Quebec | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Quebec | Recruiting | Québec | G1V 4G2 | Canada |
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.
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D047928 | Premature Birth |
| D011248 | Pregnancy Complications |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007752 | Obstetric Labor, Premature |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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maternal plasma, maternal serum and buffy coat, maternal urine, cord blood
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| 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 |
| D007744 | Obstetric Labor Complications |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |