Short summary

The aim of this study is to improve first-trimester screening regimes for the early detection of late-onset PE using novel maternal serum biomarkers in combination with maternal history, uterine artery Doppler and mean arterial blood pressure.

Rationale

Pre-eclampsia (PE) is the most frequent medical complication of pregnancy worldwide and is associated with serious short- and long-term consequences for both mother and child. Yet around 60% of prospective PE cases go undetected by current risk identification efforts and are thus left untreated until they clinically manifest in the second half of pregnancy. This diminishes the window of opportunity for effective and well documented pharmacological intervention. Effective screening for the development of early onset PE requiring delivery before 34 gestation weeks, can be provided in the first-trimester of pregnancy by a combination of maternal risk factors, mean arterial pressure, uterine artery Doppler, maternal serum pregnancy-associated plasma protein-A and placental growth factor. The Fetal Medicine Foundation (FMF) screening algorithm has proven effectively and has been validated and implemented in clinical routine in a number of countries world-wide. While this screening regime has a high detection-rate for early onset PE, it fails to effectively detect the 1-2% of pregnant women who develop late-onset PE.

Recent research suggests that specific maternal biomarkers predict the subsequent development of PE and it is believed that subsets of maternal biomarkers may reflect the specific molecular traits that characterize the different etiologies behind early and late-onset PE. Thus, it is possible that other specific serum proteins may serve as better predictors of late onset PE when evaluated in combination with maternal history and biophysical markers.

Description of the cohort

The cohort consists of pregnant women assigned to the Department of Obstetrics at Odense University Hospital for their first trimester nuchal translucency between August 15 2019 and April 1 2020; who are included/excluded according to the following inclusion criteria: planned first trimester nuchal translucency scan; informed consent; gestational age 11-14 weeks at the first trimester scan. The exclusion criteria were: age < 18 years; ≥ 2 fetuses; participants must read and understand Danish.

Data and biological material

Venous blood (plasma and serum) will be sampled, and aliquots will be stored as part of a research biobank and a biobank for future research at the Department of Clinical Biochemistry and Pharmacology (KBF) OUH.

Collaborating researchers and departments

Department of Obstetrics and Gynaecology, Odense University Hospital

• Consultant, Associate Professor Lene Sperling

Department of Obstetrics, Rigshospitalet

• Consultant Charlotte Ekelund
• Consultant Ann Tabor
• Consultant Line Rode