ROTEM® and platelet function in pre-eclamptic obstetric patients

Not Applicable

Completed

• Conditions: Pre-eclampsia; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

• Registration Number: ACTRN12617001069347
• Lead Sponsor: Royal Brisbane and Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-24
• Study Completion: 2020-03-30
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 122

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extent of platelet dysfunction in pre-eclampsia will be assessed via Multiplate results[Peripartum upon diagnosis of pre-eclampsia and presentation for obstetric review.];Platelet function will be assessed by the Multiplate test in both the substudy cohort and the study population.[Pre-elective Caesarean]

Secondary Outcome Measures

Name	Time	Method
Volume of blood loss (assessed via visual estimation)[Within 24 hours of delivery (whether it be a vaginal delivery or Caesarean section)];Incidence of primary postpartum haemorrhage (if this volume is >500mL for a vaginal delivery or >1000mL for a Caesarean section this would be defined as a primary postpartum haemorrage) (assessed via visual estimation)[Within 24 hours of delivery of the baby.]