Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000608763
Ethics application status
Approved
Date submitted
24/05/2013
Date registered
28/05/2013
Date last updated
10/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Association between maternal size and total operating room time in women undergoing caesarean section: a multicentre prospective observational study
Scientific title
Association between maternal size and total operating room time in women undergoing caesarean section: a multicentre prospective observational study
Secondary ID [1] 282559 0
None
Universal Trial Number (UTN)
U1111-1143-2500
Trial acronym
MUM SIZE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 289225 0
Caesarean delivery 289226 0
Condition category
Condition code
Anaesthesiology 289560 289560 0 0
Anaesthetics
Reproductive Health and Childbirth 289561 289561 0 0
Childbirth and postnatal care
Diet and Nutrition 289587 289587 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No intervention, observational only

Major measured endpoint total anaesthesia time, approximately two hours per patient.

Secondary endpoints collected for clinical purposes:
Aspects of anaesthesia care
Maternal body mass index
Maternal hospital stay and complications (days)
Neonatal stay and complications (days)
Intervention code [1] 287224 0
Not applicable
Comparator / control treatment
None observational only
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289656 0
Total operating room time (total anaesthesia time)
Timepoint [1] 289656 0
At time of Caesarean delivery
Secondary outcome [1] 302962 0
Association between Body Mass Index (BMI) at first antenatal visit and at delivery with total operating room time
Timepoint [1] 302962 0
Delivery
Secondary outcome [2] 302990 0
Maternal postnatal length of stay, days
Timepoint [2] 302990 0
Inpatient stay
Secondary outcome [3] 302992 0
Adult intensive care unit admission
Timepoint [3] 302992 0
Inpatient stay
Secondary outcome [4] 302993 0
Maternal return to OR within current hospital stay
Timepoint [4] 302993 0
Inpatient stay
Secondary outcome [5] 302994 0
Maternal death
Timepoint [5] 302994 0
Inpatient stay
Secondary outcome [6] 302995 0
Blood transfusion given
Timepoint [6] 302995 0
Inpatient stay
Secondary outcome [7] 302997 0
Breastfeeding on discharge
Timepoint [7] 302997 0
Inpatient stay
Secondary outcome [8] 302999 0
Neonatal Mechanical ventilation
Timepoint [8] 302999 0
Inpatient stay
Secondary outcome [9] 303001 0
Admission to neonatal intensive care
Timepoint [9] 303001 0
Inpatient stay
Secondary outcome [10] 303002 0
Perinatal death
Timepoint [10] 303002 0
Inpatient stay

Eligibility
Key inclusion criteria
1. Adults 18 years and older
2. Caesarean section both elective and emergency
3. Participating hospitals
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Maternal Age < 18 years
2. Patient requests her data, or either parent requests the baby’s data, are excluded
3. Planned combined surgery i.e. caesarean + tubal ligation, caesarean + hysterectomy caesarean + ovarian cystectomy, caesarean + fetal surgery (EXIT) etc

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/09/2013
Actual
23/11/2013
Date of last participant enrolment
Anticipated
Actual
2/02/2015
Date of last data collection
Anticipated
Actual
13/11/2015
Sample size
Target
1500
Accrual to date
Final
1457
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287347 0
University
Name [1] 287347 0
Anaesthesia, Perioperative and Pain Medicine Unit
Melbourne Medical School
The University of Melbourne
Country [1] 287347 0
Australia
Funding source category [2] 296957 0
Other Collaborative groups
Name [2] 296957 0
ANZCA Clinical Trials Network
Country [2] 296957 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Anaesthesia, Perioperative and Pain Medicine Unit
Melbourne Medical School
Medical Building 181
The University of Melbourne
Parkville, Vic 3010
Country
Australia
Secondary sponsor category [1] 286094 0
None
Name [1] 286094 0
None
Address [1] 286094 0
Country [1] 286094 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289322 0
Monash Health
Ethics committee address [1] 289322 0
Level 2, I Block
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [1] 289322 0
Australia
Date submitted for ethics approval [1] 289322 0
30/05/2013
Approval date [1] 289322 0
18/09/2013
Ethics approval number [1] 289322 0
Ethics committee name [2] 295992 0
Mercy Health HREC
Ethics committee address [2] 295992 0
163 Studley Road, Heidelberg, Vic 3084
Ethics committee country [2] 295992 0
Australia
Date submitted for ethics approval [2] 295992 0
23/10/2013
Approval date [2] 295992 0
17/02/2014
Ethics approval number [2] 295992 0
R13/48
Ethics committee name [3] 295993 0
Northeast Health Wangaratta HREC
Ethics committee address [3] 295993 0
35-47 Green St, Wangaratta VIC 3677
Ethics committee country [3] 295993 0
Australia
Date submitted for ethics approval [3] 295993 0
01/10/2013
Approval date [3] 295993 0
10/12/2013
Ethics approval number [3] 295993 0
127

Summary
Brief summary
Currently in Australia about one in five babies are delivered by Caesarean section. An increasing number of mothers having Caesarean section have increased body size. Body size is calculated from a person’s height and weight and is called BMI for body mass index. BMI is used to estimate if a person is underweight, ideal weight, overweight or obese. There is only limited information on how increased BMI affects the care for women having a Caesarean section and their babies. We plan to look at the relationship between a mother’s BMI, and how long her Caesarean section takes and whether her size is associated with complications for her or her baby after the Caesarean section. We hope this work will help plan for even better care for women having babies.
Trial website
Trial related presentations / publications
Dennis AT, Lamb KE, Story D on behalf of the MUM SIZE Investigators, et al Associations between maternal size and health outcomes for women undergoing caesarean section: a multicentre prospective observational study (The MUM SIZE Study) BMJ Open 2017;7:e015630. doi: 10.1136/bmjopen-2016-015630
Public notes
Attachments [1] 1876 1876 0 0
/AnzctrAttachments/364275-MUM SIZE Study_BMJ Open_2017.pdf (Publication)

Contacts
Principal investigator
Name 40158 0
A/Prof Alicia Dennis
Address 40158 0
Dept of Anaesthesia
Royal Women's Hopsital
20 Flemington Rd
Parkville
Vic, 3052
Country 40158 0
Australia
Phone 40158 0
61-3-90353174
Fax 40158 0
Email 40158 0
[email protected]
Contact person for public queries
Name 40159 0
Prof David Story
Address 40159 0
Anaesthesia, Perioperative and Pain Medicine Unit,
Melbourne Medical School
The University of Melbourne, Vic., 3010 Australia
Country 40159 0
Australia
Phone 40159 0
61-3-90353174
Fax 40159 0
Email 40159 0
[email protected]
Contact person for scientific queries
Name 40160 0
Prof David Story
Address 40160 0
Anaesthesia, Perioperative and Pain Medicine Unit,
Melbourne Medical School
The University of Melbourne, Vic., 3010 Australia
Country 40160 0
Australia
Phone 40160 0
61-3-90353174
Fax 40160 0
Email 40160 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
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