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NCT Number: NCT02744365

Biobank on Prematurity, Preeclampsia and Other Pregnancy Complications

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.

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Key information

Conditions

Preeclampsia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Anomalies Hypertension, Pregnancy-Induced Obstetric Labor Complications Obstetric Labor, Premature Pre-Eclampsia Pregnancy Complications Premature Birth Preterm Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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 ...)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational

Other

All women of the biobank have provided:

  • blood samples (plasma, serum and Buffy-coat)
  • urine samples
  • demographic and clinical data (maternal age, BMI, smoking status, obstetrical and medical history)
  • mean arterial blood pressure
  • ultrasound examination (datation of pregnancy at recruitment, uterine arteries doppler, placental volume, nuchal translucency in the majority of the cases)
  • access to medical record (for pregnancy/delivery outcomes, newborn birthweight, gestational age at delivery)

Primary outcomes

  1. early onset preeclampsia

    Time frame: 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 outcomes

  1. Severe preeclampsia

    Time frame: 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

  2. Fetal growth restriction

    Time frame: 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.

  3. spontaneous preterm birth

    Time frame: between 20 and 36 6/7 weeks of gestation

    sPTB is a birth occuring spontaneously between 20 and 36 6/7 weeks of gestation

  4. Fetal aneuploidies

    Time frame: diagnosed during or after pregnancy

    Any fetal chromosome that has an abnormal number of copies. Example: trisomy 13, 18 or 21.

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuel Bujold, MD, MSc

CONTACT

[email protected]

418-525-4444 ext. 47530

Sylvie Tapp, MSc

CONTACT

[email protected]

418-525-4444 ext. 46039

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Registry information

Official study title

Biobank of Data and of Human Biological Samples on Prematurity, Preeclampsia and Other Pregnancy Complications

Important dates

Study start
2015
Primary completion
2025
Study completion
2028
First posted
Apr 20, 2016
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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