An interventional study of Enhanced PE Screening in Pre-Eclampsia, sponsored by Sunnybrook Health Sciences Centre. Status unknown at 1 site in Canada. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-22.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Prevention
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.
328 studies on the registry are indexed under Eclampsia; 48 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 120 across 169 interventional studies indexed under Eclampsia.
Browse Eclampsia studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
To better identify women at risk for pre-eclampsia during pregnancy.
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.
Time frame: 11.3-13.6 weeks gestation
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.
Time frame: 11.3-13.6 weeks gestation
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.
Time frame: 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.
Time frame: 16-36 weeks gestation
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
Time frame: 11.3-13.6 weeks gestation
Turnaround time from assessment to results
The investigators will measure the turnaround time (in business day) from screening requisition reaching laboratory to report issued to SHSC via fax
Time frame: 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
Time frame: 11.3-40 weeks gestation
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre