Thrombin generation and hypertensive disorders of pregnancy. v1.0
Research type
Research Study
Full title
A prospective study investigating thrombin generation, a global assay of coagulation, as a predictor and risk stratifier for hypertensive disorders of pregnancy.
IRAS ID
139653
Contact name
Catherine Bagot
Contact email
Sponsor organisation
NHS GG&C
Research summary
10% of pregnancies are affected by hypertensive disease with over 3% being affected by the more serious condition, pre-eclampsia. These conditions often have a detrimental effect on maternal and fetal health. There is frequently pathological evidence of a hypercoagulable state in these pregnancies but no biomarkers have been identified that can predict disease development. Thrombin generation, a global coagulation assay, may accurately reflect the thrombotic phenotype. It is therefore a candidate for predicting the development of hypertensive disease in pregnancy.
We propose a prospective study in 330 women to investigate the link between thrombin generation and hypertensive disease of pregnancy. Samples to assess thrombin generation will be taken at intervals throughout pregnancy. Pregnant females aged 16 years or older will be identified at the local maternity hospital and a community midwifery centre. The primary end point will be the development of one or more criteria that constitutes a diagnosis of hypertensive disease of pregnancy.
Thrombin generation results will be used to create accurate risk stratification for the development of this condition and its severity, and potentially identify which women could benefit from anticoagulation in subsequent pregnancies.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/1088
Date of REC Opinion
22 Jul 2014
REC opinion
Favourable Opinion