Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000592246
Ethics application status
Approved
Date submitted
15/07/2009
Date registered
16/07/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Epi-No trial: Effect of intravaginal balloon device on levator trauma in mothers following childbirth
Scientific title
The Epi-No Study: Effect of antenatal intravaginal balloon device on levator trauma in mothers following childbirth
Universal Trial Number (UTN)
Trial acronym
EpiNo
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic floor trauma in childbirth 237260 0
Condition category
Condition code
Reproductive Health and Childbirth 239579 239579 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of intravaginal balloon device to distend pelvic floor muscle and reduce likelihood of traumas at childbirth, from 37 weeks' gestation to delivery. The patient inserts the device vaginally and inflates it intermittently, several times a day, to dilate the birth canal.
Intervention code [1] 236945 0
Prevention
Comparator / control treatment
Normal antenatal care
Control group
Active

Outcomes
Primary outcome [1] 238376 0
Levator trauma as assessed by translabial ultrasound
Timepoint [1] 238376 0
3 months postpartum
Secondary outcome [1] 244824 0
>20% increase in hiatal dimensions at rest as assessed by translabial ultrasound
Timepoint [1] 244824 0
3 months, 2 years postpartum
Secondary outcome [2] 244825 0
>20% increase in hiatal dimensions on Valsalva as assessed by translabial ultrasound
Timepoint [2] 244825 0
3 months, 2 years postpartum

Eligibility
Key inclusion criteria
First pregnancy progressing beyond 20 weeks, singleton, cephalic, no contraindications to normal vaginal delivery.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Complications requiring planned Caesarean Section, multiple pregnancy, malpresentation, previous pregnancies beyond 20 weeks' gestation

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants identified through Antenatal Clinics at Nepean Hospital and Royal Prince Alfred (RPA) Hospital. Allocation at time of recruitment through phone call to third party who holds a computer-generated randomisation list concealed from researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated list.
Masking / blinding
Blinded (masking 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
Recruiting
Date of first participant enrolment
Anticipated
1/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237336 0
Charities/Societies/Foundations
Name [1] 237336 0
Nepean medical Research Foundation
Country [1] 237336 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Nepean Hospital
Derby St
Penrith 2750 NSW
Country
Australia
Secondary sponsor category [1] 236822 0
None
Name [1] 236822 0
Address [1] 236822 0
Country [1] 236822 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239449 0
Sydney West Area Health Service Human Research Ethics Committee
Ethics committee address [1] 239449 0
Nepean Hospital
Derby St
Penrith 2750 NSW
Ethics committee country [1] 239449 0
Australia
Date submitted for ethics approval [1] 239449 0
25/04/2007
Approval date [1] 239449 0
30/04/2007
Ethics approval number [1] 239449 0
1/07/0022

Summary
Brief summary
The EpiNo trial is trialing the use of a commercially available intravaginal balloon device in order to determine whether this device reduces the risk of major pelvic floor trauma at vaginal delivery.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 29903 0
Address 29903 0
Country 29903 0
Phone 29903 0
Fax 29903 0
Email 29903 0
Contact person for public queries
Name 13150 0
Prof. Hans Peter Dietz
Address 13150 0
Nepean Hospital
Level 5 Spurrett Bldg.
Derby St
Penrith NSW 2750
Country 13150 0
Australia
Phone 13150 0
+61 2 4734 1474
Fax 13150 0
Email 13150 0
[email protected]
Contact person for scientific queries
Name 4078 0
Prof. Hans Peter Dietz
Address 4078 0
Nepean Hospital
Level 5 Spurrett Bldg.
Derby St
Penrith NSW 2750
Country 4078 0
Australia
Phone 4078 0
+61 2 4734 1474
Fax 4078 0
Email 4078 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
SourceTitleYear of PublicationDOI
Dimensions AIDoes the Epi-No® birth trainer prevent vaginal birth-related pelvic floor trauma? A multicentre prospective randomised controlled trial2016https://doi.org/10.1111/1471-0528.13924
N.B. These documents automatically identified may not have been verified by the study sponsor.