NCT04412681

Precision Medicine for Prediction & Prevention of Early Pre-eclampsia

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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).

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Enhanced PE Screening	To better identify women at risk for pre-eclampsia during pregnancy.

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2020-06-02
• Last updated: 2021-03-22

Locations

1 site across 1 country: Canada