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Pre-EclampsiaNCT04412681

Precision Medicine for Prediction & Prevention of Early Pre-eclampsia

A study testing Enhanced PE Screening in people with Pre-Eclampsia, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to evaluate the feasibility of implementing a clinical model for precision screening of early pre-eclampsia into the current prenatal screening service at Sunnybrook Health Sciences Center (SHSC). 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
Pre-Eclampsia
What is being tested?
Enhanced PE Screening
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
1 siteCanada
Study dates
1 Mar 2021to 1 Jun 2022
Phase
Interventional
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

Who may be able to join

  • Women with a singleton pregnancy > 18 years old
  • Not on low dose aspirin
  • Carrying a live fetus with crown rump length (CRL) between 41 and 84mm
  • Able to provide informed consent
  • Having a nuchal translucency ultrasound

Who cannot join

  • Women with a singleton pregnancy < 18 years old
  • Women currently taking low dose aspirin
  • Women declining a nuchal translucency ultrasound
  • Women unable to provide informed consent
  • Women with a multiple pregnancy
  • Women with a demised fetus or a CRL <41mm and >84mm

Trial locations and contacts

1 site in 1 country.

Ronzoni contact

4164804920

stefania.ronzoni@sunnybrook.ca

Canada1 site, 1 recruiting

  • Sunnybrook Health Sciences center

    Toronto, Ontario, M4N 3M5

    Stefania Ronzoni, stefania.ronzoni@sunnybrook.ca

    Recruiting

Other trials in Canada

About this study

Official title: Using Precision Medicine for the Prediction and Prevention of Early Pre-eclampsia: A Feasibility Study at Sunnybrook Health Sciences Centre.

This study aims to evaluate the feasibility of implementing a clinical model for precision screening of early pre-eclampsia into the current prenatal screening service at Sunnybrook Health Sciences Center (SHSC).

Read the detailed description

Pre-eclampsia (PE) represents a pregnancy-specific systemic disorder that affects 3-8% of all pregnancies. In developed countries PE is considered a major public health problem responsible for severe maternal complications such as coagulopathy, renal and liver failure, stroke, and maternal death (>76,000 maternal death annually).

The traditional approach to screening for preeclampsia endorsed by national guidelines is based on a combination of maternal characteristics along with medical, obstetric and family history.

However, although these methods are simple and easy to perform, maternal factors can only identify less than 35% of all preeclampsia and approximately 40% of preterm-preeclampsia at a false- positive rate of 10%.

More recently, multivariate analysis has been used to develop predictive models for preeclampsia that can be applied as early as 11-13+6 weeks gestation. One such algorithm, developed by the Fetal Medicine Foundation UK(MFM UK), incorporates maternal risk factors, uterine artery doppler, mean arterial pressure, and serum markers of placental function and placental growth factor. The FMFUK algorithm has been shown to predict approximately 75-90% of those women destined to develop preeclampsia prior to 37 and 34 weeks respectively, at a false positive rate of 10%. This algorithm has been validated prospectively in several studies, including the prediction of other placental mediated complications of pregnancy, such as fetal growth restriction and perinatal death.

The new clinical model will include the following additions to the existing first trimester screening for aneuploidy:

  • Additional Clinical History
  • Blood pressure measurements
  • Ultrasound for uterine artery Doppler measurements
  • Expanded prenatal screening requisition
  • Quality assurance training of ultrasound technicians for the uterine artery doppler measurements
  • Fetal Medicine Foundation validated risk calculation algorithm
  • Communicate results of the risk calculation algorithm from NYGH to SHSC and participant health care providers.

While the ultimate goal will be to scale up and adapt this new clinical model, this protocol focuses on the feasibility of implementing the new clinical model at a single centre, Sunnybrook Health Sciences Centre.

Conditions
Pre-Eclampsia
Being tested
Enhanced PE Screening
Medical subject headings
Pre-Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced PE ScreeningDiagnostic test

    To better identify women at risk for pre-eclampsia during pregnancy.

Study groups in NCT04412681
Study groupRoleWhat they receive
PE Enhanced ScreeningExperimentalThe PE screening program entails the following for all participants: * provision of additional demographic and risk factors * provision of mean arterial pressure * standard nuchal translucency scan as part of their first trimester screening (FTS) with the addition of the measurement of the uterine artery Doppler by a certified sonographer * standard blood sample (as part of the FTS) * results of the PE screening (in the format of a screening report) will be provided to the study team and participant's healthcare provider
Receives: Diagnostic Test: Enhanced PE Screening

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Screening Tool

    Implementation of the screening: To assess the feasibility, the investigators will judge success if the full screening process without deviation is completed for at least 90% of consented participants.

    Measured: 11.3-13.6 weeks gestation

Secondary outcomes (3)

  1. Accuracy of Screening

    Reproducibility of the FMFUK studies. Planning a recruitment of 1000 participants and anticipating a 10% positive rate, the invetigators expect to follow 100 screen positive and 900 screen negative pregnancies.

    Measured: 11.3-13.6 weeks gestation

  2. Acceptability of Screening Tool to Participants

    Proportion of acceptance/offer to implementation study. The investigators expect to obtain consent from 80% of pregnant women eligible for the study.

    Measured: 11.3-13.6 weeks gestation

  3. Compliance with low dose ASA for screen positive participants.

    The investigators will assess the rate of initiation and maintenance of low dose ASA ( SHSC standard of care) as measured by phone follow-up at 16,22,26,32 and 36 weeks gestation, (2) follow-up at placental scan visit and (3) follow-up at delivery. Success will defined as 80% compliance.

    Measured: 16-36 weeks gestation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2020
  2. Study start1 Mar 2021
  3. Primary completion1 Jun 2022 (estimated)
  4. Study completion1 Jun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04412681
Sponsor's protocol ID
PEprotocol
Status last verified
Mar 2021
First submitted
16 Apr 2020
Last updated
22 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wright D, Syngelaki A, Akolekar R, Poon LC, Nicolaides KH. Competing risks model in screening for preeclampsia by maternal characteristics and medical history. Am J Obstet Gynecol. 2015 Jul;213(1):62.e1-62.e10. doi: 10.1016/j.ajog.2015.02.018. Epub 2015 Feb 25.

    PubMed 25724400

  • O'Gorman N, Wright D, Poon LC, Rolnik DL, Syngelaki A, de Alvarado M, Carbone IF, Dutemeyer V, Fiolna M, Frick A, Karagiotis N, Mastrodima S, de Paco Matallana C, Papaioannou G, Pazos A, Plasencia W, Nicolaides KH. Multicenter screening for pre-eclampsia by maternal factors and biomarkers at 11-13 weeks' gestation: comparison with NICE guidelines and ACOG recommendations. Ultrasound Obstet Gynecol. 2017 Jun;49(6):756-760. doi: 10.1002/uog.17455.

    PubMed 28295782

  • Park FJ, Leung CH, Poon LC, Williams PF, Rothwell SJ, Hyett JA. Clinical evaluation of a first trimester algorithm predicting the risk of hypertensive disease of pregnancy. Aust N Z J Obstet Gynaecol. 2013 Dec;53(6):532-9. doi: 10.1111/ajo.12126. Epub 2013 Aug 6.

    PubMed 23919594

  • Mosimann B, Pfiffner C, Amylidi-Mohr S, Risch L, Surbek D, Raio L. First trimester combined screening for preeclampsia and small for gestational age - a single centre experience and validation of the FMF screening algorithm. Swiss Med Wkly. 2017 Aug 25;147:w14498. doi: 10.4414/smw.2017.14498. eCollection 2017.

    PubMed 28871576

  • O'Gorman N, Wright D, Poon LC, Rolnik DL, Syngelaki A, Wright A, Akolekar R, Cicero S, Janga D, Jani J, Molina FS, de Paco Matallana C, Papantoniou N, Persico N, Plasencia W, Singh M, Nicolaides KH. Accuracy of competing-risks model in screening for pre-eclampsia by maternal factors and biomarkers at 11-13 weeks' gestation. Ultrasound Obstet Gynecol. 2017 Jun;49(6):751-755. doi: 10.1002/uog.17399. Epub 2017 May 14.

    PubMed 28067011

  • Ananth CV, Keyes KM, Wapner RJ. Pre-eclampsia rates in the United States, 1980-2010: age-period-cohort analysis. BMJ. 2013 Nov 7;347:f6564. doi: 10.1136/bmj.f6564.

    PubMed 24201165

  • Ronzoni S, Rashid S, Santoro A, Mei-Dan E, Barrett J, Okun N, Huang T. Preterm preeclampsia screening and prevention: a comprehensive approach to implementation in a real-world setting. BMC Pregnancy Childbirth. 2025 Jan 15;25(1):32. doi: 10.1186/s12884-025-07154-6.

    PubMed 39815166

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced PE Screening in people with Pre-Eclampsia, run by Sunnybrook Health Sciences Centre 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Mar 2021. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ronzoni (4164804920, stefania.ronzoni@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Screening Tool (time frame: 11.3-13.6 weeks gestation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04412681, which also lists 7 linked publications.

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 22 Mar 2021.

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