None listed
Conditions
Brief summary
We intend to undertake this research project on ROTEM®, which is a rapid and specific blood clotting test which has been recently introduced to analyse clotting. This is a rapid test in that results can be obtained within 10 minutes, compared with 30 to 60 minutes for the current standard clotting test. It is specific in that it further defines parameters to assist in deciding what blood products need to be given in the event of bleeding. We will also analyse platelet function using a test called Multiplate®. The purpose of this study is to better understand the type and extent of clotting issues that are potentially seen with the pregnancy-related condition known as pre-eclampsia. You will not receive any direct benefit from participating in this study, but the knowledge gained from this research will help us to improve the management of major bleeding in pregnant patients. If a patient develops pre-eclampsia (uncommon condition) throughout the course of their pregnancy and if they agree to participate, then we will obtain a 7.5mL blood sample either through their IV drip or cannula when it is placed, or when they have blood tests done. This blood sample will be used to process for Multiplate® results, ROTEM® clotting test and the standard clotting test. If the patient has further routine blood tests performed, we will perform matched samples until the pre-eclampsia resolves. If a patient's pregnancy is uncomplicated and if they do not require an IV drip or any blood tests during their labour, then they will not be included in the study. As a substudy, we intend to recruit 20 women undergoing an elective Caesarean, who have experienced uncomplicated pregnancies and have no history of coagulation disorders, to establish a normal range against which the results of our main study cohort will be compared.
Interventions
Only patients with a diagnosis of pre-eclampsia will be included and blood tests in the form of ROTEM NATEM, Multiplate and the standard coagulation profile will be processed at the point of routine blood tests being done.
Sponsors
Royal Brisbane and Women's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Key inclusion criteria: • Potential study participants will be identified as per antenatal booking lists initially for the provision of information leaflets • Patients must have clinically diagnosed pre-eclampsia (the whole spectrum of the disease, including HELLP (haemolysis, elevated liver enzymes, low platelets) syndrome) • Potential participants will include inpatients of the labour ward which will include patients not yet in established labour, as well as parturients. • These patients will be included into the study upon presentation to the labour ward at the point of requiring intravenous (IV) cannulation and/or venepuncture, either for medical management, for the insertion of a labour epidural, or for induction or augmentation of labour. • Pregnant patients of any gestation will be included, as long as they have the diagnosis of pre-eclampsia confirmed or are treated for suspected pre-eclampsia • Patients requiring communication via an interpreter, mild to moderate mental illness; mild intellectual impairment; Aboriginal and Torres Strait Island patients will be coincidentally included. Key inclusion criteria for substudy of 20 patients: * Patients undergoing an elective Caesarean section * Patients with uncomplicated pregnancies and no history of coagulation abnormalities
Exclusion criteria
• All labour ward inpatients without a diagnosis of pre-eclampsia • Age < 18, age > 55, SEVERE* cognitive impairment, SEVERE mental illness, moderate to SEVERE intellectual disability. • Sampling time: ROTEM® samples must be processed within four hours and some of these samples may be missed if samples taken after-hours are unable to be processed by the limited pathology staff rostered on for that period. Processing of other specimens will take priority during the after-hours period, which may render some ROTEM® samples non-viable due to the time-constraints and these will be excluded from the study.
Outcome results
None listed