Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000443392
Ethics application status
Not yet submitted
Date submitted
30/07/2008
Date registered
5/09/2008
Date last updated
5/09/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Rapid versus stepwise negative pressure application for vacuum extraction assisted vaginal delivery


Rapid versus stepwise negative pressure application for vacuum extraction assisted vaginal delivery
Scientific title
Rapid versus stepwise negative pressure application for vacuum extraction assisted vaginal delivery
Secondary ID [1] 672 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Assisted vaginal delivery 3483 0
Condition category
Condition code
Reproductive Health and Childbirth 3639 3639 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Rapid negative pressure application: negative pressure of 0.8 kg/cm2 will be applied in one step in less than two minutes. When the final pressure has been achieved, traction will be undertaken during uterine contractions and maternal expulsive efforts.
Intervention code [1] 3207 0
Treatment: Devices
Comparator / control treatment
Stepwise negative pressure application: The conventional stepwise method consists of four incremental steps of 0.2 kg/cm2 every two minutes to obtain a final negative pressure of 0.8 kg/cm2.
Control group
Active

Outcomes
Primary outcome [1] 4537 0
Primary outcomes
Success/failure rate of vacuum extraction procedure
Timepoint [1] 4537 0
At the end of data collection phase which is about 24 months.
Secondary outcome [1] 7682 0
Birth asphyxia (apgar score < 7 at 5 minutes after birth)
Timepoint [1] 7682 0
After delivery of the baby

Eligibility
Key inclusion criteria
Uncomplicated singleton pregnancy, more than 34 weeks of gestation, cephalic presentation.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Refusal to give informed consent
• the woman is not entitled to give informed consent e.g. minors without a guardian
• severe fetal distress( as defined by attending physicians)

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)
Sequentially numbered opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
330
Accrual to date
Final
Recruitment outside Australia
Country [1] 1090 0
Thailand
State/province [1] 1090 0
Bangkok
Country [2] 1091 0
Thailand
State/province [2] 1091 0
Kalasin
Country [3] 1092 0
Thailand
State/province [3] 1092 0
Khon Kaen

Funding & Sponsors
Funding source category [1] 3703 0
Government body
Name [1] 3703 0
Thailand Research Fund
Country [1] 3703 0
Thailand
Funding source category [2] 3704 0
Government body
Name [2] 3704 0
Thailand Research Fund
Country [2] 3704 0
Thailand
Primary sponsor type
Hospital
Name
Kalasin Hospital
Address
Kalasin Hospital
Kalasin Road
Muang
Kalasin
46000
Country
Thailand
Secondary sponsor category [1] 3289 0
Hospital
Name [1] 3289 0
Khon Kaen Hospital
Address [1] 3289 0
Srichan Road
Khon Kaen
40000
Country [1] 3289 0
Thailand
Secondary sponsor category [2] 3321 0
University
Name [2] 3321 0
Khon Kaen University
Address [2] 3321 0
123 Mitraparb Road
Khon Kaen
Thailand
40002
Country [2] 3321 0
Thailand
Secondary sponsor category [3] 3322 0
University
Name [3] 3322 0
Khon Kaen University
Address [3] 3322 0
123 Mitraparb Road
Khon Kaen
Country [3] 3322 0
Thailand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5757 0
Ethics committee address [1] 5757 0
Ethics committee country [1] 5757 0
Date submitted for ethics approval [1] 5757 0
21/08/2008
Approval date [1] 5757 0
Ethics approval number [1] 5757 0

Summary
Brief summary
Vacuum extraction is a common procedure for assisting vaginal delivery. Traditionally, negative pressure application was recommended to be increased stepwisely.
This trial aims to assess the effectiveness and safety of rapid versus stepwise negative pressure application for assisted vaginal delivery by vacuum extraction. This will be a hospital-based, multicentre, randomized controlled trial. Women eligible for the study are those with an uncomplicated singleton pregnancy of more than 34 weeks of gestation, with a cephalic presentation. Vacuum extraction procedure will be performed by application to the fetal head with a metal cup (Malmstrom, 50 mm) connected to an electric pump. The conventional stepwise method consists of four incremental steps of 0.2 kg/cm2 every two minutes to obtain a final negative pressure of 0.8 kg/cm2. In the rapid method the negative pressure of 0.8 kg/cm2 will be applied in one step in less than two minutes. When the final pressure has been achieved, traction will be undertaken during uterine contractions and maternal expulsive efforts. If there is detachment of the vacuum cup, it will be applied again, if clinically appropriate, to the fetal head in the manner indicated by the initial randomization. Thailand Research Fund by Senior Research Scholar will be responsible for funding and financial oversight of the centres. The trial will show whether rapid negative pressure application technique of vacuum extraction is as good as stepwise technique regarding effectiveness and safety.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28791 0
Address 28791 0
Country 28791 0
Phone 28791 0
Fax 28791 0
Email 28791 0
Contact person for public queries
Name 11948 0
Pisake Lumbiganon
Address 11948 0
Department of Ob & Gyn
Faculty of Medicine
Khon Kaen University
Khon Kaen
40002
Country 11948 0
Thailand
Phone 11948 0
66-81-871-9039
Fax 11948 0
66-43-348-395
Email 11948 0
[email protected]
Contact person for scientific queries
Name 2876 0
Pisake Lumbiganon
Address 2876 0
Department of Ob & Gyn
Faculty of Medicine
Khon Kaen University
Khon Kaen
40002
Country 2876 0
Thailand
Phone 2876 0
66-81-871-9039
Fax 2876 0
66-43-348395
Email 2876 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.