Biobank on Prematurity, Preeclampsia and Other Pregnancy Complications

Laval University

Status: Enrolling

Conditions: Pregnancy Complications; Preeclampsia; Fetal Anomalies; Preterm Birth

Treatments: Other: Observational

Study type: Observational

Funder types: Other

Identifiers

NCT02744365

2015-2272

Details and patient eligibility

About

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.

Full 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 ...)

Enrollment: 7,845 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

7,845 participants in 5 patient groups

Prediction Group

Description:

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).

Treatment:

Other: Observational

PEARL Group

Description:

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)

Treatment:

Other: Observational

GAP Group

Description:

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.

Treatment:

Other: Observational

PREDICTION 2 Group

Description:

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).

Treatment:

Other: Observational

HAUPE Study

Description:

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)

Treatment:

Other: Observational