Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001070224
Ethics application status
Approved
Date submitted
14/12/2009
Date registered
14/12/2009
Date last updated
14/12/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intrapartum intrauterine resuscitation: Does maternal oxygen administration influence the status of the newborn baby?
Scientific title
Intrapartum intrauterine resuscitation: Does maternal oxygen administration influence the status of the newborn baby?
Secondary ID [1] 1197 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The effect of maternal oxygen administration, in suspected fetal compromise, on the status of the newborn baby 252384 0
Condition category
Condition code
Reproductive Health and Childbirth 256566 256566 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients randomised for oxygen by 40% face mask at 10 litres/minute till delivery of the baby (from the time when fetal compromise was diagnosed). 40% Oxygen is double the consentration we breathe (21%)
Intervention code [1] 255686 0
Treatment: Other
Comparator / control treatment
Routine intrapartum care and do not receive any oxygen. This involve turning patient on left side, administer Intravenous fluids and supress contractions if needed.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257460 0
5 minute Apgar score
Timepoint [1] 257460 0
At birth (5 minutes after birth)
Primary outcome [2] 257461 0
need for resuscitation
Timepoint [2] 257461 0
during the first 30 minutes of life
Secondary outcome [1] 262611 0
Neonatal intensive care unit(NICU) admission
Timepoint [1] 262611 0
First few days of life, till discharge from hospital
Secondary outcome [2] 262630 0
Need for ventilation
Timepoint [2] 262630 0
Till discharge from hospital
Secondary outcome [3] 262631 0
Onset of hypoxic ischemic encephalopathy
Timepoint [3] 262631 0
Till discharge from hospital
Secondary outcome [4] 262632 0
Cerebral palsy
Timepoint [4] 262632 0
First year of life

Eligibility
Key inclusion criteria
Fetal compromise
Gestation more than 32 weeks
Vertex presentation
Maternal age more than 18 years
Minimum age
32 Weeks
Maximum age
42 Weeks
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Gestation less than 32 weeks
Multiple pregnancies
Non-vertex presentation
Maternal age less than 18 years

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consecutively numbered opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation list
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment outside Australia
Country [1] 2364 0
South Africa
State/province [1] 2364 0

Funding & Sponsors
Funding source category [1] 256172 0
Self funded/Unfunded
Name [1] 256172 0
Jacobus du Plessis
Country [1] 256172 0
Australia
Primary sponsor type
University
Name
University of Free State
Address
P.O.Box 399(G71)
Bloemfontein
9300
Country
South Africa
Secondary sponsor category [1] 251512 0
None
Name [1] 251512 0
Address [1] 251512 0
Country [1] 251512 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258276 0
Faculty of Health Science, University of Free State
Ethics committee address [1] 258276 0
P.O. Box 399(G71)
Bloemfontein
9300
Ethics committee country [1] 258276 0
South Africa
Date submitted for ethics approval [1] 258276 0
Approval date [1] 258276 0
16/03/2007
Ethics approval number [1] 258276 0
ETOVS 30/07

Summary
Brief summary
Does maternal oxygen administration, in suspected fetal compromise, influence the status of the newborn baby? All patients received all the components of intrauterine resuscitation, except oxygen. Patients were then randomised to the receive oxygen or no oxygen.
Currently there are no randomised trials to test this question
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30613 0
Address 30613 0
Country 30613 0
Phone 30613 0
Fax 30613 0
Email 30613 0
Contact person for public queries
Name 13860 0
Jacobus du Plessis
Address 13860 0
Royal Womens Hospital
20 Flemington Road
Parkville
Victoria
3052
Country 13860 0
Australia
Phone 13860 0
+61431371887
Fax 13860 0
Email 13860 0
Jacobus.DuPlessis@thewomens.org.au
Contact person for scientific queries
Name 4788 0
Jacobus du Plessis
Address 4788 0
Royal womens Hospital
20 Flemington Road
Parkville
Victoria
3052
Country 4788 0
Australia
Phone 4788 0
+61431371887
Fax 4788 0
Email 4788 0
Jacobus.DuPlessis@thewomens.org.au

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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