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Trial registered on ANZCTR


Registration number
ACTRN12616000761460
Ethics application status
Approved
Date submitted
16/02/2016
Date registered
9/06/2016
Date last updated
16/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Rotation thromboelastometry (ROTEM 'Registered Trademark') in obstetrics: baseline parameters in normal and complicated pregnancies. A prospective observational study on elective Caesarean patients.
Scientific title
ROTEM ('Registered Trademark') thromboelastometry in elective Caesarean patients: baseline parameters in normal and complicated pregnancies.
Secondary ID [1] 288559 0
Nil
Universal Trial Number (UTN)
Trial acronym
RTC (ROTEM Thromboelastometry in elective Caesarean patients)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 297674 0
Pregnancy-related conditions 297675 0
Coagulopathies 297676 0
Condition category
Condition code
Reproductive Health and Childbirth 297853 297853 0 0
Normal pregnancy
Blood 297854 297854 0 0
Clotting disorders
Reproductive Health and Childbirth 298992 298992 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
A 3.5mL (or 7mL if complicated/high-risk for correlation with a coagulation profile) blood sample will be taken to process for a ROTEM profile, at the point of IV cannula insertion pre-operatively. No follow-up with the patient required, but medical records will be reviewed as part of data collection regarding birth outcomes (estimated blood loss, neonatal outcomes).
Intervention code [1] 293939 0
Diagnosis / Prognosis
Comparator / control treatment
Patients in the normal pregnancy group will act as the comparator.
Control group
Active

Outcomes
Primary outcome [1] 297380 0
ROTEM profile assessed using whole blood analysis
Timepoint [1] 297380 0
At the point of IV cannulation pre-operatively
Primary outcome [2] 298522 0
Outcome of delivery (whether there were any complications in relation to the mother or baby) will be assessed by review of medical records.
Timepoint [2] 298522 0
At the time of delivery (intra-operatively)
Primary outcome [3] 298532 0
Estimated blood loss by review of medical records
Timepoint [3] 298532 0
At the time of delivery
Secondary outcome [1] 320885 0
Analysis of changesin coagulation as assessed by ROTEM seen in patients with pregnancy complications and coagulopathies
Timepoint [1] 320885 0
ROTEM will be performed pre-induction of anaesthesia for Caesarean section.

Eligibility
Key inclusion criteria
Pregnant and of greater than 30 weeks gestation.
Booked for an elective Caesarean section.
Minimum age
18 Years
Maximum age
55 Years
Gender
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 approximately 100 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. It is difficult in this setting with the aim of deriving normal baseline values for ROTEM and thus formal power calculations cannot be applied. The statistical advice given was to recruit as many patients as possible over a defined study period.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 12745 0
4006 - Bowen Hills

Funding & Sponsors
Funding source category [1] 292903 0
Government body
Name [1] 292903 0
The University of Queensland
Address [1] 292903 0
The University of Queensland
School of Medicine, St Lucia, QLD 4067
Country [1] 292903 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] 291649 0
None
Name [1] 291649 0
N/A
Address [1] 291649 0
N/A
Country [1] 291649 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294403 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 294403 0
RBWH
Butterfield St
Herston QLD 4006
Ethics committee country [1] 294403 0
Australia
Date submitted for ethics approval [1] 294403 0
24/10/2014
Approval date [1] 294403 0
03/12/2014
Ethics approval number [1] 294403 0
HREC/14/QRBW/496

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 63614 0
Dr Julie Lee
Address 63614 0
The Royal Brisbane and Women's Hospital
Department of Anaesthesia and Perioperative Medicine
Level 4, Ned Hanlon Building
Butterfield St
RBWH, Herston QLD 4029
Country 63614 0
Australia
Phone 63614 0
+617 36468111
Fax 63614 0
Email 63614 0
julielee01@gmail.com
Contact person for public queries
Name 63615 0
Dr Julie Lee
Address 63615 0
Department of Anaesthesia and Perioperative Medicine
Level 4, Ned Hanlon Building
The Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
Country 63615 0
Australia
Phone 63615 0
+617 36468111
Fax 63615 0
Email 63615 0
julielee01@gmail.com
Contact person for scientific queries
Name 63616 0
Dr Julie Lee
Address 63616 0
Department of Anaesthesia and Perioperative Medicine
Level 4, Ned Hanlon Building
The Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4006
Country 63616 0
Australia
Phone 63616 0
+61418838821
Fax 63616 0
Email 63616 0
julielee01@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary