Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000760471
Ethics application status
Approved
Date submitted
17/09/2015
Date registered
9/06/2016
Date last updated
7/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Rotational Thromboelastometry (ROTEM ('Registered Trademark') in obstetrics: baseline parameters in normal and complicated pregnancies. A prospective observational study on labour ward inpatients.
Scientific title
ROTEM ('Registered Trademark') thromboelastometry in parturients: baseline parameters in normal and complicated pregnancies.
Secondary ID [1] 287494 0
Nil
Universal Trial Number (UTN)
U1111-1174-6060
Trial acronym
RTLW (ROTEM Thromboelastometry in Labouring Women)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 296241 0
Pregnancy-related conditions 296242 0
Labour 297465 0
Coagulopathies 297466 0
Condition category
Condition code
Reproductive Health and Childbirth 296512 296512 0 0
Normal pregnancy
Blood 296513 296513 0 0
Clotting disorders
Reproductive Health and Childbirth 299072 299072 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
ROTEM thromboelastometry profile. A 3.5mL sample (or 7mL sample in high risk patients where coagulation profiles will be tested in addition to the ROTEM profile) will be taken at the point of venepuncture or IV cannulation when the patient is admitted to the labour ward. No follow-up required apart from data collection regarding mode of delivery, estimated blood loss and neonatal outcomes.
Intervention code [1] 293938 0
Diagnosis / Prognosis
Comparator / control treatment
Coagulation profiles will be processed for complicated pregnancies. The normal pregnancy group will act as the comparator group for correlation of results.
Control group
Active

Outcomes
Primary outcome [1] 296137 0
ROTEM profile assessed using whole blood analysis
Timepoint [1] 296137 0
At the point of venepuncture or IV cannulation upon admission to the labour ward.
Primary outcome [2] 298523 0
Outcome of delivery (mode of delivery, whether it was a normal vaginal delivery, assisted or progressed to a Caesarean section; any complications related to the mother or baby will be noted) will be assessed by review of medical records.
Timepoint [2] 298523 0
At the time of delivery
Primary outcome [3] 298531 0
Estimated blood loss will be assessed by review of medical records.
Timepoint [3] 298531 0
At the time of delivery
Secondary outcome [1] 317592 0
Analysis of changes in ROTEM parameters seen in patients with pregnancy complications and coagulopathies
Timepoint [1] 317592 0
ROTEM samples will be taken upon presentation to the labour ward, at the point of IV cannulation or venepuncture.

Eligibility
Key inclusion criteria
Pregnant and of greater than 30 weeks gestation; in established labour
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Severe cognitive impairment, severe mental illness, moderate to severe intellectual disability

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Statistical advice has been provided by the Statistics Department of the Queensland Institute of Medical Research. The proposed study period will be 12 months and based on estimates, there will be up to 500 patients potentially included in the study, at which point we will review our data to assess the need for further extension of this study. Demographic and baseline data will be presented as frequencies/percent for categorical data or means/standard deviations for continuous data. Continuous data will be analysed using analysis of variance (ANOVA), and the chi square test will be applied to categorical data.

The main aim of this study is to generate normal baseline ranges for ROTEM parameters in order to develop an algorithm for use in the pregnant population, therefore it is difficult to perform a sample size calculation for this purpose. Statistical advice given has recommended the recruitment of as many patients as possible over a defined study period .

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Number of participants recruited deemed statistically sufficient.
Date of first participant enrolment
Anticipated
Actual
2/07/2015
Date of last participant enrolment
Anticipated
1/09/2016
Actual
31/12/2016
Date of last data collection
Anticipated
Actual
31/03/2017
Sample size
Target
500
Accrual to date
Final
195
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4357 0
Royal Brisbane & Womens Hospital - Herston

Funding & Sponsors
Funding source category [1] 292069 0
Government body
Name [1] 292069 0
Pathology Queensland
Country [1] 292069 0
Australia
Primary sponsor type
Hospital
Name
The Royal Brisbane and Women's Hospital
Address
The Royal Brisbane and Women's Hospital
Butterfield St, Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 290744 0
None
Name [1] 290744 0
Address [1] 290744 0
Country [1] 290744 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293552 0
Royal Brisbane and Women's Hospital HREC
Ethics committee address [1] 293552 0
RBWH
Butterfield St
Herston QLD 4029
Ethics committee country [1] 293552 0
Australia
Date submitted for ethics approval [1] 293552 0
Approval date [1] 293552 0
03/12/2014
Ethics approval number [1] 293552 0
HREC/14/QRBW/497

Summary
Brief summary
Recruitment of parturients will occur at the Royal Brisbane and Women’s Hospital (RBWH). There is increasing use of ROTEM(TM) for point-of-care coagulation monitoring in patients with massive haemorrhage, but there still remains limited data on reference ranges in normal pregnancies and subsequently limited understanding of the effects of complicated pregnancies on ROTEM(TM) interpretation. With the recent implementation of ROTEM(TM) within the RBWH, reference ranges for the obstetric population need to be established to optimise interpretation of derived values.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56466 0
Dr Julie Lee
Address 56466 0
Royal Brisbane and Women's Hospital
Department of Anaesthesia
Butterfield St, Herston
QLD 4029
Country 56466 0
Australia
Phone 56466 0
+617 3646 8111
Fax 56466 0
Email 56466 0
[email protected]
Contact person for public queries
Name 56467 0
Dr Julie Lee
Address 56467 0
Royal Brisbane and Women's Hospital
Department of Anaesthesia
Butterfield St, Herston
QLD 4029
Country 56467 0
Australia
Phone 56467 0
+617 3646 8111
Fax 56467 0
Email 56467 0
[email protected]
Contact person for scientific queries
Name 56468 0
Dr Julie Lee
Address 56468 0
Royal Brisbane and Women's Hospital
Department of Anaesthesia
Butterfield St, Herston
QLD 4029
Country 56468 0
Australia
Phone 56468 0
+617 3646 8111
Fax 56468 0
Email 56468 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.