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| Name | Class |
|---|---|
| North York General Hospital | OTHER |
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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).
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PE Enhanced Screening | Experimental | The PE screening program entails the following for all participants:
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced PE Screening | Diagnostic Test | To better identify women at risk for pre-eclampsia during pregnancy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 11.3-13.6 weeks gestation |
| Acceptability of Screening Tool to Participants |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of the assessment | The investigators will assess the duration (in minute) required for completing data questionnaire, measuring arterial blood pressure and uterine artery Doppler | 11.3-13.6 weeks gestation |
| Turnaround time from assessment to results |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ronzoni | Contact | 4164804920 | stefania.ronzoni@sunnybrook.ca |
| Name | Affiliation | Role |
|---|---|---|
| Ronzoni | Sunnybrook Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences center | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25724400 | Background | 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. | |
| 28295782 | 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. |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Proportion of acceptance/offer to implementation study. The investigators expect to obtain consent from 80% of pregnant women eligible for the study. |
| 11.3-13.6 weeks gestation |
| 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. | 16-36 weeks gestation |
The investigators will measure the turnaround time (in business day) from screening requisition reaching laboratory to report issued to SHSC via fax
| 11.3-16 weeks gestation |
| Participant Satisfaction | The investigators will assess participant satisfaction with screening and care through a satisfaction survey with a 10 score scale where 1 is very unsatisfied and 10 is very satified | 11.3-40 weeks gestation |
| 23919594 | 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. |
| 28871576 | 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. |
| 28067011 | 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. |
| 24201165 | 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. |
| 39815166 | Derived | 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. |