Biobank on Prematurity, Preeclampsia and Other Pregnancy Complications
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational.
- Who it may be relevant to
- Registry conditions: Preeclampsia, Preterm Birth, Pregnancy Complications, Fetal Anomalies. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Biobank of Data and of Human Biological Samples on Prematurity, Preeclampsia and Other Pregnancy Complications
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.
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 ...)
Interventions
- Other 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
Primary outcome measures
- early onset preeclampsia [Time frame: diagnosed between 20 and 34 weeks of gestation]
Secondary outcome measures (4)
- Severe preeclampsia [Time frame: between 20 and 42 weeks of gestation]
- Fetal growth restriction [Time frame: between 20 and 42 weeks of gestation]
- spontaneous preterm birth [Time frame: between 20 and 36 6/7 weeks of gestation]
- Fetal aneuploidies [Time frame: diagnosed during or after pregnancy]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Canada · 1 center
- CHU de Quebec — Québec
Identifiers
NCT: NCT02744365 · 2015-2272