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Trial registered on ANZCTR


Registration number
ACTRN12615000018516
Ethics application status
Approved
Date submitted
4/12/2014
Date registered
15/01/2015
Date last updated
23/11/2018
Date data sharing statement initially provided
23/11/2018
Date results information initially provided
23/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does subcutaneous fat measured at 18­20 weeks predict difficulty inserting an epidural or adverse pregnancy  outcomes?
Scientific title
In pregnant women, does the abdominal subcutaneous fat measured by ultrasound at 18-22 weeks predict pregnancy outcomes or difficulty of insertion of neuraxial anaesthesia?
Secondary ID [1] 285690 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 293546 0
Adiposity measured by subcutaneous fat 293547 0
Condition category
Condition code
Reproductive Health and Childbirth 293822 293822 0 0
Fetal medicine and complications of pregnancy
Anaesthesiology 293823 293823 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Abdominal subcutaneous fat measured by ultrasound at 18-22 weeks gestation, as a measure of central adiposity.

Part 1: SCF measured at 18-22 weeks gestation will be analyzed against obesity-related pregnancy outcomes (maternal and fetal) to determine if it can be used to predict such outcomes. The observation period will last from the time the measurement is taken until the week after the fetus has been delivered.

Part 2. In women booked for elective caesarean section, the measurement of subcutaneous fat taken at 18-22 weeks gestation will be analysed against the anaesthetist's difficulty palpating landmarks, the number of insertion attempts and the US measurement of lumbar subcutaneous fat. The aim is to determine if the SCF measurement can be used to predict these outcomes. The observation period will last from the time of the SCF measurement, until the completion of the anaesthetic.
Intervention code [1] 290630 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293607 0
Maternal outcome
(pre-eclampsia, gestational diabetes, haemorrhage requiring transfusion, mode of delivery)
Timepoint [1] 293607 0
Antenatal (at 18-22 weeks gestation)
Post-natal (1 week after delivery of the fetus)
Primary outcome [2] 293922 0
Fetal Outcome
Birth weight, length and head circumference, APGAR score at 5 minutes, hypoglycaemia, gestation, respiratory support, destination,
Timepoint [2] 293922 0
First 48 hours of life
Primary outcome [3] 293923 0
Difficulty palpating lumbar landmarks
This will be rated by the treating anaesthetist at the time of palpation as easy (easily able to palpate lumbar spinous processes at multiple levels in sitting position with minimal/moderate compression of subcutaneous tissue), moderate (able to palpate L3/4 spinous process in sitting position with significant compression of subcutaneous tissues in optimal position) or hard (unable to palpate lumbar spinous process despite significant compression and optimal positioning)
Timepoint [3] 293923 0
At the time of anaesthesia for elective caesarean section
Secondary outcome [1] 311466 0
Difficulty inserting neuraxial
Rated by the anaesthetist as easy, moderate or hard (definitions available)
Number of insertions of the needle through the skin, number of re-directions of the needle within the back
Timepoint [1] 311466 0
At the time of anaesthetic for elective caesarean section

Eligibility
Key inclusion criteria
All participants must be pregnant (pregnancy is the "health condition" required for eligibility)
For part 1: all women presenting to the RBWH for an 18-22 week scan and do not opt-out.
For part 2: Women booked for elective caesarean section (Category 4);
women who have had a SCF measurement taken at the RBWH on their 18-22 week USS; women who are reasonably expected to have regional anaesthesia for their caesarean section.
Minimum age
16 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Part 1: For the purposes of analysis exclusion criteria will be: referral to the alcohol and drugs service for significant drug or alcohol use; failure to attend at least one antenatal appointment.
Part 2: Participants who do not have regional anaesthesia, or have an emergency caesarean section (category 1,2,3).

Study design
Purpose
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
For Part 1, the SCF will be measured for 12 months which should yield between 800-1000 measurements - statistical advice is that this will be sufficient. The SCF measurement will be analysed according to the outcome data, to determine if there is a relationship between the SCF thickness and any of the outcome variables. ANOVA, Chi square and multiple logistic regression will be used. For Part 2, the sample size is currently being calculated from a pilot study but will be in the order of 100-200 (Part 1 will commence while this number is being finalised). The number of attempts inserting the epidural and the difficulty palpating landmarks will be analysed against the SCF measurement using ANOVA and Chi-square.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/03/2015
Actual
2/03/2015
Date of last participant enrolment
Anticipated
6/03/2017
Actual
13/06/2016
Date of last data collection
Anticipated
Actual
13/06/2018
Sample size
Target
1000
Accrual to date
Final
997
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3152 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 8929 0
4006 - Herston

Funding & Sponsors
Funding source category [1] 290259 0
Hospital
Name [1] 290259 0
The Royal Brisbane and Women's Hospital
Department of Anaesthesia and Perioperative Medicine
Country [1] 290259 0
Australia
Funding source category [2] 290480 0
University
Name [2] 290480 0
The University of Queensland
Country [2] 290480 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] 288965 0
University
Name [1] 288965 0
The University of Queensland
Address [1] 288965 0
St Lucia
QLD 4072
Country [1] 288965 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292057 0
HREC of the Royal Brisbane and Women's Hospital
Ethics committee address [1] 292057 0
Level 7, Block 7.
Butterfield St
Herston 4006
QLD
Ethics committee country [1] 292057 0
Australia
Date submitted for ethics approval [1] 292057 0
Approval date [1] 292057 0
03/12/2014
Ethics approval number [1] 292057 0
HREC/14/QRBW/492

Summary
Brief summary
This study will test two hypotheses and consist of two parts:
1. Part 1. The thickness of abdominal SCF, measured by ultrasound at 18-22 weeks gestation, predicts maternal outcomes (gestational diabetes, pregnancy-related hypertensive disorders, mode of delivery) and fetal outcomes (estimated fetal weight, birth outcome, gestational age, gender, weight, length, head circumference, large for gestational age, small for gestational age, intrauterine growth restriction).
2. Part 2. The thickness of abdominal SCF, measured by ultrasound at 18-22 weeks gestation, predicts the difficulty inserting an epidural, the difficulty palpating the landmarks of epidural insertion and the subcutaneous fat measured at lumbar interspace L3-4.
Trial website
Trial related presentations / publications
Increased maternal abdominal subcutaneous fat thickness and body mass index are associated with increased cesarean delivery: A prospective cohort study.
Acta Obstetricia et Gynecologica Scandinavica DOI: 10.1111/aogs.13486
Public notes

Contacts
Principal investigator
Name 52850 0
Dr Victoria Eley
Address 52850 0
The Royal Brisbane and Women's Hospital (RBWH)
Butterfield St
Herston 4006
QLD
Country 52850 0
Australia
Phone 52850 0
+617 38127616
Fax 52850 0
Email 52850 0
[email protected]
Contact person for public queries
Name 52851 0
Victoria Eley
Address 52851 0
RBWH
Butterfield St
Herston 4006
QLD
Country 52851 0
Australia
Phone 52851 0
+61738127616
Fax 52851 0
Email 52851 0
[email protected]
Contact person for scientific queries
Name 52852 0
Victoria Eley
Address 52852 0
RBWH
Butterfield St
Herston 4006
QLD
Country 52852 0
Australia
Phone 52852 0
+617438127616
Fax 52852 0
Email 52852 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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Eley VA, Chin A, Sekar R, Donovan T, Krepska A, Be... [More Details]
Study results articleYes Eley VA, Chin A, Sekar R, Donovan T, Krepska A, Be... [More Details]

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
55Study results articleYes Eley VA, Chin A, Sekar R, Donovan T, Krepska A, Be... [More Details]
92Study results articleYes Eley VA, Chin A, Sekar R, Donovan T, Krepska A, Be... [More Details]
3029Plain language summaryNo Maternal abdominal SCFT and BMI were both signific... [More Details]

Documents added automatically
No additional documents have been identified.