Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001236684
Ethics application status
Approved
Date submitted
17/11/2014
Date registered
26/11/2014
Date last updated
23/11/2018
Date data sharing statement initially provided
23/11/2018
Date results provided
23/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
What is the failure rate of extending epidural analgesia to anaesthesia for emergency caesarean section in women with a body mass index greater than 40 compared with women with a body mass index < 30? A prospective cohort study.
Scientific title
In pregnant women with a body mass index greater than 40, is epidural extension for emergency caesarean section more likely to fail, compared with women with a body mass index less than 30?
Secondary ID [1] 285205 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity in pregnancy
 292821 0
Condition category
Condition code
Anaesthesiology 293115 293115 0 0
Anaesthetics
Reproductive Health and Childbirth 293116 293116 0 0
Childbirth and postnatal care
Diet and Nutrition 293877 293877 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Exposure is body mass index > 40 or body mass index <30. the primary outcome is the success or failure of use of their epidural for their anaesthetic for caesarean section. The outcome will be measured at the time of caesarean section.
Intervention code [1] 290079 0
Not applicable
Comparator / control treatment
The group with a BMI<30 is considered to be the control group
Control group
Active

Outcomes
Primary outcome [1] 292982 0
The rate of failure to extend an existing labour epidural to successful anaesthesia for caesarean section, described as an odds ratio. Failure will be defined as:
1. use of an alternative neuraxial technique
2. general anaesthesia was administered:
a) as a pre-operative decision, before skin incision
b) as an intra-operative decision, after skin incision
Timepoint [1] 292982 0
Time of anaesthesia for caesarean section
Primary outcome [2] 293606 0
Use of the labour epidural as the anaesthetic technique
Timepoint [2] 293606 0
At time of anaesthesia for caesarean section
Secondary outcome [1] 310073 0
Secondary outcome measures: Demographic data, details of antenatal care, co-morbidities, insertion of the labour epidural and anaesthetic management for caesarean section will be collected in order to determine potential predictors of extension failure
Timepoint [1] 310073 0
Before and during anaesthesia for caesarean section

Eligibility
Key inclusion criteria
Antenatal BMI greater than 40 after the 30 week of pregnancy
Intending to have vaginal delivery
Utilise epidural analgesia.
Require Category 1 or 2 caesarean section (according to RANZCOG7 criteria).
Women in the control group (BMI less than 30) will meet the same criteria.
Minimum age
15 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Age less than 15 years, age greater than 45 years, acute haemorrhage or sepsis identified prior to delivery, known intrauterine fetal death prior to delivery, failure to attend one antenatal appointment, cardiovascular disease with New York Heart Association (NYHA) classification >3, respiratory disease with NYHA >3, SEVERE cognitive impairment, SEVERE mental illness, SEVERE intellectual disability

Study design
Purpose
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data from a pilot study conducted at the RBWH, using identical definitions, were used in calculating the sample size. Assuming a failure rate of 0.159 in the control group, the study group will require 100 participants with 200 control participants, to detect an odds ratio of 2.27 (alpha equals 0.05 and beta equals 0.8). Recruiting from two sites it may be estimated that full data collection may take three years.

The primary outcome measure will be analysed using Chi-square statistic. Demographic and baseline data will be presented as frequencies/percent for categorical data or means/standard deviations for continuous data. Multiple logistic regression will be used to determine significant predictors of extension failure.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/03/2015
Actual
2/03/2015
Date of last participant enrolment
Anticipated
Actual
13/03/2017
Date of last data collection
Anticipated
Actual
13/03/2017
Sample size
Target
300
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 8631 0
4006 - Herston
Recruitment postcode(s) [2] 8632 0
4101 - South Brisbane
Recruitment postcode(s) [3] 15638 0
4114 - Logan City

Funding & Sponsors
Funding source category [1] 290258 0
Hospital
Name [1] 290258 0
The Royal Brisbane and Women's Hospital
Country [1] 290258 0
Australia
Primary sponsor type
Hospital
Name
The Royal Brisbane and Women's Hospital
Address
Butterfield St
Herston 4006
QLD
Country
Australia
Secondary sponsor category [1] 288964 0
None
Name [1] 288964 0
nil
Address [1] 288964 0
nil
Country [1] 288964 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291552 0
Queensland Health Central Office
Ethics committee address [1] 291552 0
Ethics committee country [1] 291552 0
Australia
Date submitted for ethics approval [1] 291552 0
07/08/2014
Approval date [1] 291552 0
21/08/2014
Ethics approval number [1] 291552 0
HREC/14/QHC/36

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50846 0
Dr Victoria Eley
Address 50846 0
Department of Anaesthesia and Perioperative Medicine
The Royal Brisbane and Women's Hospital
Butterfield St, Herston 4006
QLD
Country 50846 0
Australia
Phone 50846 0
+61 7 3646 1775
Fax 50846 0
Email 50846 0
[email protected]
Contact person for public queries
Name 50847 0
Victoria Eley
Address 50847 0
Department of Anaesthesia and Perioperative Medicine
The Royal Brisbane and Women's Hospital
Butterfield St, Herston 4006
QLD
Country 50847 0
Australia
Phone 50847 0
+61 7 3646 1775
Fax 50847 0
Email 50847 0
[email protected]
Contact person for scientific queries
Name 50848 0
Victoria Eley
Address 50848 0
Department of Anaesthesia and Perioperative Medicine
The Royal Brisbane and Women's Hospital
Butterfield St, Herston 4006
QLD
Country 50848 0
Australia
Phone 50848 0
+61 7 3646 1775
Fax 50848 0
Email 50848 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent not provided


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.