Biobank on Prematurity, Preeclampsia and Other Pregnancy Complications

Recruiting

• Conditions: Pregnancy Complications; Preterm Birth; Fetal Anomalies; Preeclampsia
• Interventions: Other: Observational

• Registration Number: NCT02744365
• Lead Sponsor: CHU de Quebec-Universite Laval

Brief Summary

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 ...)

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-04-15
• Study First Submitted QC: 2016-04-15
• Study First Posted: 2016-04-20
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-16
• Primary Completion: 2025-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 7845

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HAUPE Study	Observational	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)
PEARL Group	Observational	The women recruited in the biobank through the PEARL Study (NCT02379832) are : 1. low-risk pregnant women between 11 and 13 6/7 weeks of gestation (controls, N=45) 2. pregnant women with diagnosis of preeclampsia between 20 and 41 6/7 weeks of gestation (cases, N=45)
GAP Group	Observational	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.
Prediction Group	Observational	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).
PREDICTION 2 Group	Observational	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).

Primary Outcome Measures

Name	Time	Method
early onset preeclampsia	diagnosed between 20 and 34 weeks of gestation	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

Secondary Outcome Measures

Name	Time	Method
Fetal aneuploidies	diagnosed during or after pregnancy	Any fetal chromosome that has an abnormal number of copies. Example: trisomy 13, 18 or 21.
Severe preeclampsia	between 20 and 42 weeks of gestation	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
spontaneous preterm birth	between 20 and 36 6/7 weeks of gestation	sPTB is a birth occuring spontaneously between 20 and 36 6/7 weeks of gestation
Fetal growth restriction	between 20 and 42 weeks of gestation	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.

Trial Locations

Locations (1)

CHU de Quebec; 🇨🇦 Quebec, Canada