PreeclampsiaPREDICTION2NCT03067298
Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening
An observational study of Preeclampsia and Preterm Birth, run by Emmanuel Bujold at 1 site in Canada.
Trial summary
Preterm birth (PTB), preeclampsia (PE), fetal growth restriction (FGR) and intra-uterine fetal death (IUFD) constitutes the main causes of perinatal morbidity and mortality and are called "Great Obstetrical Syndromes". 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, Fetal Growth Restriction
- How many people
- 805 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Pregnant women
Who may be able to join
- nulliparous pregnant women participating in Prediction study (NCT02189148)
Who cannot join
- <18 years old at recruitment;
- multiple pregnancies;
- fetal congenital malformation;
- positive for HIV or hepatitis C;
- fetal demise at recruitment;
- women planning a delivery outside the participating hospitals;
- women not able to provide an informed consent to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Preterm birth (PTB), preeclampsia (PE), fetal growth restriction (FGR) and intra-uterine fetal death (IUFD) constitutes the main causes of perinatal morbidity and mortality and are called "Great Obstetrical Syndromes". Algorithms to predict those outcomes have been developed by combining maternal characteristics (history, age, BMI, blood pressure), biochemical (sFlt-1, β-hCG, PlGF, AFP) and sonographic (uterine artery Doppler, 3D of placenta, cervical length, nasal bone measurement, nuchal translucency) markers. Another prospective observational study ("PREDICTION study" NCT 02189148) is also ongoing, which aims to validate those algorithms at the first trimester of pregnancy.
Recent data suggest that repeating the same measurements later in pregnancy could improve the detection rates, allowing closer monitoring of high-risk patients and potential therapeutics under investigation. The current study (PREDICTION2) is an ancillary study of PREDICTION and aims at validating the use of these markers in a combined iterative manner in the prediction of preeclampsia and other obstetrical outcomes.
Read the detailed description
The objective of this study is to validate the predictive values of biophysical (maternal blood pressure); biochemical (sFlt-1, β-hCG, PlGF, and AFP) and ultrasonographic (cervical length, Doppler, 3D evaluation of the placenta, 3D nasal bone) biomarkers at several timepoints for the prediction of adverse pregnancy outcomes including preterm birth, preeclampsia, fetal growth restriction and intra-uterine fetal death.
These biomarkers will be evaluated at 14-16 weeks, 20-24 weeks and 30-34 weeks. Those specific gestational ages have been selected because they correspond to the typical clinical/hospital visits for prenatal blood and/or ultrasound screening.
- Keywords
- pregnancy, screening, doppler, markers, PlGF, sFlt-1, placenta
- Medical subject headings
- Pre-Eclampsia, Premature Birth, Fetal Growth Retardation
What is being measured
The primary outcome is the main question the study is designed to answer.
preeclampsia
- de novo hypertension with systolic blood pressure ≥ 140 mmHg or diastolic blood pressure >90 mmHg on two occasions at least four hours apart, after 20 weeks of pregnancy, and 2) associated with proteinuria ≥300 mg/24 h or at least '2 +' protein on urine dipstick or an adverse conditions
Measured: >20 weeks of preeclampsia
Secondary outcomes (3)
Fetal growth restriction
defined as a birth weight below the 10th centile (or below the 3rd centile for severe FGR) of Canadian reference growth charts.
Measured: neonatal weight at birth (on the day of birth)
Preterm birth
defined as delivery <37 weeks of gestation.
Measured: between 20-37 weeks of gestation
Intra uterine fetal death
fetal death during pregnancy
Measured: from the 20th week of gestation to the moment of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study startOct 2016
- Primary completionJun 2019
- Study completionJun 2021
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 805 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emmanuel Bujold
- Sponsor type
- University, hospital or other
- Collaborators
- Thermo Fisher Scientific, Inc, Laval University
- Responsible party
- Sponsor-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
- NCT03067298
- Sponsor's protocol ID
- 2017-3219
- Acronym
- PREDICTION2
- Status last verified
- Mar 2022
- First submitted
- 18 Jan 2017
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening
- ClinicalTrials.gov ID
- NCT03067298
- Acronym / sponsor ID
- PREDICTION2 / 2017-3219
- Keywords
- pregnancy, screening, doppler, markers, PlGF, sFlt-1, placenta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 805 participants (actual)
- Lead sponsor
- Emmanuel BujoldUniversity, hospital or other
- Collaborators
- Thermo Fisher Scientific, Inc, Laval University
- Study start
- Oct 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 1 Mar 2017 (actual)
- 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.
Preterm birth (PTB), preeclampsia (PE), fetal growth restriction (FGR) and intra-uterine fetal death (IUFD) constitutes the main causes of perinatal morbidity and mortality and are called "Great Obstetrical Syndromes". Algorithms to predict those outcomes have been developed by combining maternal characteristics (history, age, BMI, blood pressure), biochemical (sFlt-1, β-hCG, PlGF, AFP) and sonographic (uterine artery Doppler, 3D of placenta, cervical length, nasal bone measurement, nuchal translucency) markers. Another prospective observational study ("PREDICTION study" NCT 02189148) is also ongoing, which aims to validate those algorithms at the first trimester of pregnancy.
Recent data suggest that repeating the same measurements later in pregnancy could improve the detection rates, allowing closer monitoring of high-risk patients and potential therapeutics under investigation. The current study (PREDICTION2) is an ancillary study of PREDICTION and aims at validating the use of these markers in a combined iterative manner in the prediction of preeclampsia and other obstetrical outcomes.
Detailed description
The objective of this study is to validate the predictive values of biophysical (maternal blood pressure); biochemical (sFlt-1, β-hCG, PlGF, and AFP) and ultrasonographic (cervical length, Doppler, 3D evaluation of the placenta, 3D nasal bone) biomarkers at several timepoints for the prediction of adverse pregnancy outcomes including preterm birth, preeclampsia, fetal growth restriction and intra-uterine fetal death.
These biomarkers will be evaluated at 14-16 weeks, 20-24 weeks and 30-34 weeks. Those specific gestational ages have been selected because they correspond to the typical clinical/hospital visits for prenatal blood and/or ultrasound screening.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women
Key inclusion criteria (1 listed)
- nulliparous pregnant women participating in Prediction study (NCT02189148)
Key exclusion criteria (7 listed)
- <18 years old at recruitment;
- multiple pregnancies;
- fetal congenital malformation;
- positive for HIV or hepatitis C;
- fetal demise at recruitment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
preeclampsia
Time frame: >20 weeks of preeclampsia
1) de novo hypertension with systolic blood pressure ≥ 140 mmHg or diastolic blood pressure >90 mmHg on two occasions at least four hours apart, after 20 weeks of pregnancy, and 2) associated with proteinuria ≥300 mg/24 h or at least '2 +' protein on urine dipstick or an adverse conditions
3 secondary outcomes
Fetal growth restriction
Time frame: neonatal weight at birth (on the day of birth)
Preterm birth
Time frame: between 20-37 weeks of gestation
Intra uterine fetal death
Time frame: from the 20th week of gestation to the moment of birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: No
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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
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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. This study is not recruiting at the moment.
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 Emmanuel Bujold 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 7 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: finished, as of the sponsor's last update on 15 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preeclampsia (time frame: >20 weeks of preeclampsia). 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 15 Mar 2022.