Biobank on Prematurity, Preeclampsia and Other Pregnancy Complications
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCHU de Quebec-Universite Laval
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
(specific to each study)
Disqualifiers
pregnant women <18 years old at recruitment
negative fetal heart at recruitment
women not able to provide an informed consent to the study
Trial population
According to each study: 1. Prediction study: Nulliparous women between 11 and 13 6/7 weeks of gestation 2. PEARL study: Nulliparous women between 11 and 13 6/7 weeks of gestation or diagnosed with preeclampsia between 20 and 42 weeks of gestation 3. GAP Study: women with twin pregnancy between 11 and 13 6/7 weeks of gestation 4. Prediction-2 study: Nulliparous women with singleton pregnancy without fetal anomaly/demise between 14 and 15 6/7 weeks of gestation
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Observational
Other interventionAll 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)
Treatment groups
7,845 Participants
are divided into 5 treatment groupsGroup A: Prediction Group1 intervention
Group B: PEARL Group1 intervention
Group C: GAP Group1 intervention
Group D: PREDICTION 2 Group1 intervention
Group E: HAUPE Study1 intervention
Trial outcomes
Primary outcomes
1
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 gestationSecondary outcomes
1
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 gestation2
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 gestation3
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 gestation4
Fetal aneuploidies
Any fetal chromosome that has an abnormal number of copies. Example: trisomy 13, 18 or 21.
Time frame
diagnosed during or after pregnancySponsors and contacts
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Source ClinicalTrials.gov