Biobank on Prematurity, Preeclampsia and Other Pregnancy Complications

NCT ID: NCT02744365

Last Updated: 2022-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

7845 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2028-04-30

Brief Summary

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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

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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 ...)

Conditions

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Preeclampsia Preterm Birth Pregnancy Complications Fetal Anomalies

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Observational

Intervention Type 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)

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)

Observational

Intervention Type 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

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.

Observational

Intervention Type 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)

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).

Observational

Intervention Type 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)

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)

Observational

Intervention Type 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)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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CHU de Quebec-Universite Laval

OTHER

Sponsor Role lead

Responsible Party

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Emmanuel Bujold

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emmanuel Bujold, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

CHU de Quebec

Locations

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CHU de Quebec

Québec, , Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Emmanuel Bujold, MD, MSc

Role: CONTACT

418-525-4444 ext. 47530

Sylvie Tapp, MSc

Role: CONTACT

418-525-4444 ext. 46039

Facility Contacts

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Emmanuel Bujold, MD, MSc

Role: primary

418-525-4444 ext. 47530

Sylvie Tapp, MSc

Role: backup

418-525-4444 ext. 46009

Other Identifiers

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2015-2272

Identifier Type: -

Identifier Source: org_study_id

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