PreeclampsiaNCT02744365
Biobank on Prematurity, Preeclampsia and Other Pregnancy Complications
An observational study of Preeclampsia and Preterm Birth, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Preterm Birth, Pregnancy Complications
- What is being tested?
- Observational
- How many people
- 7,845 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- (specific to each study)
Who cannot join
- pregnant women <18 years old at recruitment
- negative fetal heart at recruitment
- women not able to provide an informed consent to the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
CHU de Quebec
Québec, G1V 4G2
Emmanuel Bujold, MD, MSc, 418-525-4444 ext. 47530, emmanuel.bujold@crchudequebec.ulaval.ca
Sylvie Tapp, MSc, 418-525-4444 ext. 46009, sylvie.tapp@crchudequebec.ulaval.ca
About this study
Official title: Biobank of Data and of Human Biological Samples 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.
Read the 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 ...)
- Conditions
- Preeclampsia, Preterm Birth, Pregnancy Complications, Fetal Anomalies
- Being tested
- Observational
- Medical subject headings
- Pre-Eclampsia, Premature Birth, Pregnancy Complications, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: 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. Receives: 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). Receives: 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) Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: diagnosed between 20 and 34 weeks of gestation
Secondary outcomes (4)
Severe preeclampsia
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
Measured: between 20 and 42 weeks of gestation
Fetal growth restriction
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.
Measured: between 20 and 42 weeks of gestation
spontaneous preterm birth
sPTB is a birth occuring spontaneously between 20 and 36 6/7 weeks of gestation
Measured: between 20 and 36 6/7 weeks of gestation
Fetal aneuploidies
Any fetal chromosome that has an abnormal number of copies. Example: trisomy 13, 18 or 21.
Measured: diagnosed during or after pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startApr 2015
- Primary completionApr 2025 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 7,845 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emmanuel Bujold, CHU de Quebec-Universite Laval
- Investigators
- Emmanuel Bujold, MD, MSc, Principal investigator, CHU de Quebec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744365
- Sponsor's protocol ID
- 2015-2272
- Status last verified
- Mar 2022
- First submitted
- 15 Apr 2016
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobank of Data and of Human Biological Samples on Prematurity, Preeclampsia and Other Pregnancy Complications
- ClinicalTrials.gov ID
- NCT02744365
- Acronym / sponsor ID
- 2015-2272
- Conditions
- Preeclampsia, Preterm Birth, Pregnancy Complications, Fetal Anomalies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,845 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Prediction Group | – | Other: ObservationalThe 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). |
| PEARL Group | – | Other: ObservationalThe 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) |
| GAP Group | – | Other: ObservationalThe 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. |
| PREDICTION 2 Group | – | Other: ObservationalThe 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). |
| HAUPE Study | – | Other: ObservationalWomen 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- (specific to each study)
Key exclusion criteria (3 listed)
- pregnant women <18 years old at recruitment
- negative fetal heart at recruitment
- women not able to provide an informed consent to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalAll 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) | Other | GAP Group, HAUPE Study, PEARL Group, PREDICTION 2 Group, Prediction Group |
Primary outcome
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
4 secondary outcomes
Severe preeclampsia
Time frame: between 20 and 42 weeks of gestation
Fetal growth restriction
Time frame: between 20 and 42 weeks of gestation
spontaneous preterm birth
Time frame: between 20 and 36 6/7 weeks of gestation
Fetal aneuploidies
Time frame: diagnosed during or after pregnancy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Preeclampsia
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Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emmanuel Bujold, MD, MSc principal investigator
CHU de Quebec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Preterm Birth, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel Bujold, MD, MSc (418-525-4444 ext. 47530, emmanuel.bujold@crchudequebec.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early onset preeclampsia (time frame: diagnosed between 20 and 34 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.