Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000636954
Ethics application status
Approved
Date submitted
14/06/2011
Date registered
22/06/2011
Date last updated
22/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The WISH Project - Working to Improve Survival and Health for babies born very preterm.
Scientific title
Monitoring and improving the uptake of antenatal magnesium sulphate as a neuroprotective therapy to reduce the risk of cerebral palsy and death in babies born very preterm.
Secondary ID [1] 262193 0
Nil
Universal Trial Number (UTN)
U1111-1121-5232
Trial acronym
The WISH Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 265876 0
perinatal mortality 268122 0
preterm birth 268123 0
Condition category
Condition code
Reproductive Health and Childbirth 266033 266033 0 0
Antenatal care

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The WISH Project is a prospective cohort study that will collect neonatal and maternal outcome data associated with very preterm birth occurring in the years 2011 to 2013. The WISH Project is focussed on observing outcomes associated with the increasing implementation of the 2010 National Clinical Practice Guidelines regarding antenatal magnesium sulphate for neuroprotection of the fetus, infant and child. The WISH Project is also observing more generally the antenatal care of women who present with very preterm labour.

The outcomes that will be observed in this study will include rates of cerebral palsy, perinatal mortality and other complications of prematurity in babies born very preterm. Observations will also be made about the antenatal care of women who present with preterm labour, including corticosteroid, antibiotic and tocolytic use.

Data will be obtained from medical records and from the Australian and New Zealand Neonatal Network Data Collection. As part of dissemination of the National Clincial Practice Guidelines: "Antenatal Magnesium Sulphate Prior to Preterm Birth for Neuroprotection of the Fetus, Infant and Child", posters, information sheets, powerpoint presentations and case note reminder inserts may be used as strategies for implementation.
Intervention code [1] 264596 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266776 0
The proportion of women giving birth after 22 weeks' gestation (excluding known lethal congenital anomalies) and before 30 weeks' gestation receiving antenatal magnesium sulphate. This outcome will be obtained from medical records.
Timepoint [1] 266776 0
In 2011, 2012, and 2013.
Primary outcome [2] 266777 0
Deaths prior to primary hospital discharge of babies born after 22 weeks gestation and before 30 weeks gestation in 2011, 2012, and 2013. This outcome will be obtained from medical records and the Australian and New Zealand Neonatal Network Data Collection.
Timepoint [2] 266777 0
In 2011, 2012, and 2013.
Primary outcome [3] 266778 0
Cerebral palsy rate at up to three years' corrected age (in babies born alive after 22 weeks' gestation and before 30 weeks' gestation in 2011). This outcome data is obtained at standard paediatric assessment between the ages of 18 months and 3 years, and will be obtained by those centres involved in the WISH project from medical records.
Timepoint [3] 266778 0
Between 2013 and 2014.
Secondary outcome [1] 276374 0
Maternal adverse events related to administration of magnesium sulphate therapy (nausea, vomiting, respiratory depression, respiratory arrest, cardiac arrest, hypotension, tachycardia, admission to ICU, flushing, headache, diarrhoea, dizziness, drowsiness, need to be given calcium gluconate). These outcomes will be collected from medical records.
Timepoint [1] 276374 0
In 2011, 2012 and 2013.
Secondary outcome [2] 276375 0
Maternal adverse events sufficient to stop therapy. Possible adverse effects include: nausea, vomiting, respiratory depression, respiratory arrest, cardiac arrest, hypotension, tachycardia, admission to ICU, flushing, headache, diarrhoea, dizziness, drowsiness, need to be given calcium gluconate. These events will be assessed by the clinicians involved in the care of the women. The information will then be accessed from maternal case notes.
Timepoint [2] 276375 0
In 2011, 2012 and 2013.

Eligibility
Key inclusion criteria
All women giving birth after 22 weeks' gestation (excluding known lethal congenital anomalies) and before 30 weeks' gestation at the participating hospitals.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Fetuses with known lethal congenital anomalies.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 3593 0
New Zealand
State/province [1] 3593 0

Funding & Sponsors
Funding source category [1] 267098 0
Charities/Societies/Foundations
Name [1] 267098 0
Cerebral Palsy Foundation
Country [1] 267098 0
Australia
Primary sponsor type
Individual
Name
Professor Caroline Crowther
Address
Australian Research Centre for Health of Women and Babies
Discipline of Obstetrics and Gynaecology
The University of Adelaide
Women's & Children's Hospital
72 King William Road,
North Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 264183 0
Individual
Name [1] 264183 0
Ms Philippa Middleton
Address [1] 264183 0
Australian Research Centre for Health of Women and Babies
Discipline of Obstetrics and Gynaecology
The University of Adelaide
Women's & Children's Hospital
72 King William Road,
North Adelaide SA 5006
Country [1] 264183 0
Australia
Secondary sponsor category [2] 264199 0
Individual
Name [2] 264199 0
A/Prof Vicki Flenady
Address [2] 264199 0
Mater Mother's Research Centre
Mater Health Services
University of Queensland
Woolloongabba QLD 4102
Country [2] 264199 0
Australia
Secondary sponsor category [3] 264200 0
Individual
Name [3] 264200 0
Prof. Jonathan Morris
Address [3] 264200 0
Discipline of Obstetrics, Gynaecology and Neonatalology,
University of Sydney
Royal North Shore Hospital
St Leonards NSW 2065
Country [3] 264200 0
Australia
Other collaborator category [1] 252015 0
Individual
Name [1] 252015 0
Ms Sarah McIntyre
Address [1] 252015 0
Cerebral Palsy Institute, University of Notre Dame Australia
160 Oxford Street
Darlinghurst NSW 1300
Country [1] 252015 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267083 0
Women's & Children's Hospital Research Ethics Committee
Ethics committee address [1] 267083 0
Ethics committee country [1] 267083 0
Australia
Date submitted for ethics approval [1] 267083 0
Approval date [1] 267083 0
30/11/2010
Ethics approval number [1] 267083 0
EC00197

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

Contacts
Principal investigator
Name 32619 0
Address 32619 0
Country 32619 0
Phone 32619 0
Fax 32619 0
Email 32619 0
Contact person for public queries
Name 15866 0
Ms Philippa Middleton
Address 15866 0
Australian Research Centre for Health of Women and Babies
Discipline of Obstetrics and Gynaecology
The University of Adelaide
Women's and Children's Hospital
72 King William Road,
North Adelaide, SA, 5006
Country 15866 0
Australia
Phone 15866 0
+61 8 8161 7612
Fax 15866 0
Email 15866 0
[email protected]
Contact person for scientific queries
Name 6794 0
Professor Caroline Crowther
Address 6794 0
Australian Research Centre for Health of Women and Babies
Discipline of Obstetrics and Gynaecology
The University of Adelaide
Women's and Children's Hospital
72 King William Road,
North Adelaide, SA, 5006
Country 6794 0
Australia
Phone 6794 0
+61 8 8161 7617
Fax 6794 0
Email 6794 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.