Precision Medicine for Prediction & Prevention of Early Pre-eclampsia

NCT04412681 | Unknown

• 1 other identifier: PEprotocol
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (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.

  11.3-13.6 weeks gestation

Secondary Outcomes (3)

• Accuracy of Screening

  11.3-13.6 weeks gestation

• Acceptability of Screening Tool to Participants

  11.3-13.6 weeks gestation

• Compliance with low dose ASA for screen positive participants.

  16-36 weeks gestation

Other Outcomes (3)

• Duration of the assessment

  11.3-13.6 weeks gestation

• Turnaround time from assessment to results

  11.3-16 weeks gestation

• Participant Satisfaction

  11.3-40 weeks gestation

Study Arms (1)

PE Enhanced Screening

EXPERIMENTAL

The 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

Diagnostic Test: Enhanced PE Screening

Interventions

Enhanced PE Screening DIAGNOSTIC_TEST

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

PE Enhanced Screening

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• North York General Hospital: collaborator

Study Sites (1)

Sunnybrook Health Sciences center

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Related Publications (7)

• 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.

  PMID: 25724400 BACKGROUND

• 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.

  PMID: 28295782 BACKGROUND

• 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.

  PMID: 23919594 BACKGROUND

• 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.

  PMID: 28871576 BACKGROUND

• 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.

  PMID: 28067011 BACKGROUND

• 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.

  PMID: 24201165 BACKGROUND

• 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.

  PMID: 39815166 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ronzoni

  Sunnybrook Health Sciences Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronzoni

CONTACT

4164804920; stefania.ronzoni@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: June 2, 2020
• Study Start: March 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 22, 2021

Record last verified: 2021-03

Locations

CA (1)