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Biobank on Prematurity, Preeclampsia and Other Pregnancy Complications

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ClinicalTrials.gov Identifier: NCT02744365
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Emmanuel Bujold, CHU de Quebec-Universite Laval

Tracking Information
First Submitted Date April 15, 2016
First Posted Date April 20, 2016
Last Update Posted Date July 24, 2017
Study Start Date April 2015
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 15, 2016)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02744365 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 15, 2016)
  • 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
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biobank on Prematurity, Preeclampsia and Other Pregnancy Complications
Official Title Biobank of Data and of Human Biological Samples on Prematurity, Preeclampsia and Other Pregnancy Complications
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
maternal plasma, maternal serum and buffy coat, maternal urine, cord blood
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
Condition
  • Preeclampsia
  • Preterm Birth
  • Pregnancy Complications
  • Fetal Anomalies
Intervention Other: Observational

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)
Study Groups/Cohorts
  • 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).
    Intervention: 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)
    Intervention: 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.
    Intervention: 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).
    Intervention: 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)
    Intervention: Other: Observational
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 20, 2017)
7845
Original Estimated Enrollment
 (submitted: April 15, 2016)
7725
Estimated Study Completion Date April 2020
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Emmanuel Bujold, MD, MSc 418-525-4444 ext 47530 emmanuel.bujold@crchudequebec.ulaval.ca
Contact: Sylvie Tapp, MSc 418-525-4444 ext 46039 sylvie.tapp@crchudequebec.ulaval.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02744365
Other Study ID Numbers 2015-2272
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: We will publish the results linked to the data collected. We will share these data with other groups that are interested in research on preeclampsia and other pregnancy complications.
Responsible Party Emmanuel Bujold, CHU de Quebec-Universite Laval
Study Sponsor CHU de Quebec-Universite Laval
Collaborators Not Provided
Investigators
Principal Investigator: Emmanuel Bujold, MD, MSc CHU de Quebec
PRS Account CHU de Quebec-Universite Laval
Verification Date July 2017