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Trial record 26 of 56 for:    severe preeclampsia AND gestational

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

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.

Condition or disease Intervention/treatment
Preeclampsia Preterm Birth Pregnancy Complications Fetal Anomalies Other: Observational

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 ...)

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Study Type : Observational
Estimated Enrollment : 7845 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Biobank of Data and of Human Biological Samples on Prematurity, Preeclampsia and Other Pregnancy Complications
Study Start Date : April 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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

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)

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

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
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

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)

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

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)

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

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)




Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
maternal plasma, maternal serum and buffy coat, maternal urine, cord blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744365


Contacts
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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

Locations
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Canada
CHU de Quebec Recruiting
Quebec, Canada, G1V 4G2
Contact: Emmanuel Bujold, MD, MSc    418-525-4444 ext 47530    emmanuel.bujold@crchudequebec.ulaval.ca   
Contact: Sylvie Tapp, MSc    418-525-4444 ext 46009    sylvie.tapp@crchudequebec.ulaval.ca   
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Investigators
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Principal Investigator: Emmanuel Bujold, MD, MSc CHU de Quebec

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Responsible Party: Emmanuel Bujold, Professor, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT02744365     History of Changes
Other Study ID Numbers: 2015-2272
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017
Individual Participant Data (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.
Additional relevant MeSH terms:
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Pre-Eclampsia
Premature Birth
Pregnancy Complications
Congenital Abnormalities
Hypertension, Pregnancy-Induced
Obstetric Labor, Premature
Obstetric Labor Complications