Biobank on Prematurity, Preeclampsia and Other Pregnancy Complications

NCT02744365 | Recruiting

• 1 other identifier: 2015-2272
• Study Type: observational
• Target: 7,845
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia; Preterm Birth; Pregnancy Complications; Fetal Anomalies

Outcome Measures

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

  diagnosed between 20 and 34 weeks of gestation

Secondary Outcomes (4)

• Severe preeclampsia

  between 20 and 42 weeks of gestation

• Fetal growth restriction

  between 20 and 42 weeks of gestation

• spontaneous preterm birth

  between 20 and 36 6/7 weeks of gestation

• Fetal aneuploidies

  diagnosed during or after pregnancy

Study Arms (5)

Prediction Group

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).

Other: Observational

PEARL Group

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)

Other: Observational

GAP Group

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.

Other: Observational

PREDICTION 2 Group

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).

Other: Observational

HAUPE Study

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)

Other: Observational

Interventions

Observational OTHER

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 delivery)

GAP Group; HAUPE Study; PEARL Group; PREDICTION 2 Group; Prediction Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• (specific to each study)

You may not qualify if:

• pregnant women \<18 years old at recruitment
• negative fetal heart at recruitment
• women not able to provide an informed consent to the study

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

CHU de Quebec

Québec, G1V 4G2, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

maternal plasma, maternal serum and buffy coat, maternal urine, cord blood

MeSH Terms

Conditions

Pre-Eclampsia; Premature Birth; Pregnancy Complications; Congenital Abnormalities

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Emmanuel Bujold, MD, MSc

  CHU de Quebec

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuel Bujold, MD, MSc

CONTACT

418-525-4444; emmanuel.bujold@crchudequebec.ulaval.ca

Sylvie Tapp, MSc

CONTACT

418-525-4444; sylvie.tapp@crchudequebec.ulaval.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: April 20, 2016
• Study Start: April 1, 2015
• Primary Completion: April 1, 2025
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)