Evaluation of assay for ruling out pre-eclampsia
Research type
Research Study
Full title
Evaluating the Roche Elecsys pre-eclampsia assay for ruling out pre-eclampsia in patients with uncertain diagnosis.
IRAS ID
222667
Contact name
Laura McGavin
Contact email
Sponsor organisation
NHS Lanarkshire
Duration of Study in the UK
0 years, 7 months, 31 days
Research summary
Pre-eclamptic toxaemia (PET) is one of the leading causes of maternal and foetal morbidity and mortality worldwide, and affects approximately 5 - 7% of pregnancies in Western Europe. PET is a disease that is usually diagnosed by newly developed hypertension (high blood pressure) occurring after 20 weeks gestation with proteinuria(protein in the urine), however hypertension is known to complicate up to 10% of pregnancies. There are also pregnant women where diagnosis is uncertain due to delayed presentation of symptoms and clinical features. Currently, any pregnant woman presenting with signs or symptoms that may suggest PET are monitored closely to follow the development of the disease. This can involve taking blood multiple times, monitoring of blood pressure over a course of time and can often involve admitting the patient to hospital as a precaution and to monitor the patient more closely. Those patients presenting with hypertension and/or proteinuria are managed as PET. The cohort of pregnant women with an uncertain diagnosis may present with symptoms such as headaches, visual disturbances, or epigastric pain.The soluble fms-like tyrosine kinase-1 (sflt-1) and placental growth factor (PlGF) are proteins found in the placenta. Patients with PET have higher levels of circulating sflt-1 that falls after delivery, which is also associated with decreased levels of PlGF during pregnancy. The Elecsys pre-eclampsia (Elecsys PE) assay is an assay designed by Roche Diagnostics Ltd that measures the sflt-1:PlGF ratio to help in ruling out PET as a diagnosis. This study will determine whether the Elecsys PE assay is appropriate for use in the assessment of pregnant women with non-specific symptoms, in order to rule-out PET as a cause, which may result in fewer patient visits to the day bed unit and fewer admissions to hospital.
REC name
London - Surrey Research Ethics Committee
REC reference
17/LO/0850
Date of REC Opinion
7 Jul 2017
REC opinion
Further Information Favourable Opinion