Biobank on Prematurity, Preeclampsia and Other Pregnancy Complications

CHU de Quebec-Universite Laval7,845 enrolled

Overview

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 ...)

Study Type

OBSERVATIONAL

Enrollment

7,845

Conditions

Preeclampsia Preterm Birth Pregnancy Complications Fetal Anomalies

Interventions

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

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: diagnosed between 20 and 34 weeks of gestation

Secondary Outcomes

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

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: diagnosed during or after pregnancy