Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000448640
Ethics application status
Approved
Date submitted
7/12/2013
Date registered
1/05/2014
Date last updated
1/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Epidural pain relief and the outcome of labour
Scientific title
A randomised controlled trial of epidural analgesia maintenance during the second stage of labour, in primigravids in preventing of pelvic floor trauma
Secondary ID [1] 283574 0
nil
Universal Trial Number (UTN)
U1111-1150-1821
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic floor trauma following vaginal delivery 290476 0
Condition category
Condition code
Reproductive Health and Childbirth 290869 290869 0 0
Other reproductive health and childbirth disorders
Renal and Urogenital 290870 290870 0 0
Other renal and urogenital disorders
Anaesthesiology 292114 292114 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves patients who wish to have epidural analgesia in labour. All will have 0.2% Ropivacaine & Fentanyl 2microgm in labour. They will be randomised into intervention or non intervention group :

Intervention : Epidural infusion maintained / continued throughout 2nd stage.
Intervention code [1] 288396 0
Prevention
Comparator / control treatment
Non intervention : Epidural infusion discontinued at the beginning of 2nd stage of labour (as per routine practice in labour suite)
Control group
Active

Outcomes
Primary outcome [1] 291027 0
Pelvic floor trauma namely perineal tears, vaginal tears, anal sphincter injuries and levator ani avulsions, assessed by clinical examination and translabial and transperineal ultrasound.
Timepoint [1] 291027 0
3 months and 2 years postpartum.
Secondary outcome [1] 305862 0
The obstetric outcomes as a composite outcome : the length of first and second stage of labour, rate of instrumental delivery and caesarean section, obtained from review electronic medical and labour records.
Timepoint [1] 305862 0
Immediate postpartum
Secondary outcome [2] 305863 0
The clinical efficacy (analgesia, motor and sympathetic block); assessed by the Bromage score.
Timepoint [2] 305863 0
In labour (intrapartum)

Eligibility
Key inclusion criteria
1. Primigravidas or those without previous pregnancies that progressed to 20+ weeks of gestation.
2. Singleton pregnancy.
3. Aiming for vaginal delivery.
4. Participant is able to understand the risks and potential benefits of participating in the study.
5. Participant is willing and fit to provide a written consent.
6. Participant is willing and has the ability to comply with specified follow-up evaluations.
7. Aged 16 and above
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Contraindication to epidural.
2. Neurological disease.
3. Muscular or skin disorder affecting tissue elasticity.
4. Previous pelvic surgery affecting vaginal anatomy.

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)
1. Potential participants identified from antenatal clinic record.

2. An invitation letter will be mailed to potential participants, followed by an invitation phone call a week later by a member of the research team for recruitment.

3. Interested participants will be seen at 36-38 weeks of gestation by the research team during which a Patient Information Sheet will be handed out. The Patient Information Sheet will contain information about the study including the aim, potential risks and benefits and the contact numbers of the research team. Any doubt or questions from the partipants will be clarified and answered. An informed consent for participation in the study will be obtained.

4. A pre-delivery (antenatal) interview and a pelvic floor assessment will be performed at this stage once the client consented to participate. The pelvic floor assessment will involve a vaginal examination for assessment of pelvic floor strength and a 4D trans-labial ultrasound.

5. In labour, participants who decide not to proceed with epidural analgesia will be excluded. Participants will be seen by the anaesthetic team who will obtain informed consent for epidural analgesia and insert the epidural as per local protocol.

6. Participants will be randomised into the ‘intervention group’ or ’non-intervention group’.

**Allocation is concealed by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
1. Treatment received analysis
2. Dose related analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2013
Actual
5/06/2013
Date of last participant enrolment
Anticipated
30/06/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1679 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 7617 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 288253 0
Self funded/Unfunded
Name [1] 288253 0
Country [1] 288253 0
Primary sponsor type
Individual
Name
Prof. Hans Peter Dietz
Address
Department of Obstetrics, Gynaecology & Neonatology
Sydney Medical School Nepean,
62, Derby Street,
Kingswood
2747 NSW
Country
Australia
Secondary sponsor category [1] 286970 0
Individual
Name [1] 286970 0
Dr. Kevin Hall
Address [1] 286970 0
Department of Anaesthesiology
Nepean Hospital,
Derby Street
Kingswood 2747 NSW
Country [1] 286970 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290269 0
Nepean Blue Mountains Local Health District HREC
Ethics committee address [1] 290269 0
Court Building,
P.O. Box 63,
Penrith NSW 2751
Ethics committee country [1] 290269 0
Australia
Date submitted for ethics approval [1] 290269 0
Approval date [1] 290269 0
13/09/2012
Ethics approval number [1] 290269 0
12/32 - HREC/12/NEPEAN/65

Summary
Brief summary
The aim of this pilot study is to investigate whether pelvic floor muscle relaxation by maintaining the epidural infusion in the second stage of labour may reduce maternal birth trauma. The primary outcome measure will be pelvic floor trauma namely perineal tears, vaginal tears, anal sphincter injuries and levator ani avulsions. Secondary outcome measures include the length of first and second stage of labour, rate of instrumental delivery and caesarean section, and the clinical efficacy (analgesia, motor and sympathetic block) of the two epidural regimes to be tested.

RESEARCH HYPOTHESES
1. Maintenance epidural infusion of 0.2% Ropivacaine + Fentanyl 2microgram/ml throughout the second stage of labour can reduce pelvic floor trauma.
2. Maintenance epidural infusion throughout second stage does not increase duration of labour, rate of instrumental and operative delivery.
3. Maintenance epidural infusion throughout second stage of labour provides effective analgesia with a low complication rate.
Trial website
NIL
Trial related presentations / publications
NIL
Public notes
NIL

Contacts
Principal investigator
Name 44226 0
Dr Kevin Hall
Address 44226 0
Anaesthetic Department,
Nepean Hospital,
Derby Street,
Kingswood 2747 NSW
Country 44226 0
Australia
Phone 44226 0
+61412155030
Fax 44226 0
Email 44226 0
[email protected]
Contact person for public queries
Name 44227 0
Dr IXORA KAMISAN ATAN
Address 44227 0
Sydney Medical School Nepean,
The University of Sydney,
62, Derby Street,
Kingswood
2747 NSW
Country 44227 0
Australia
Phone 44227 0
+61247344756
Fax 44227 0
+61247341817
Email 44227 0
[email protected]
Contact person for scientific queries
Name 44228 0
Prof Hans Peter Dietz
Address 44228 0
Sydney Medical School Nepean,
The University of Sydney,
62, Derby Street,
Kingswood
2747 NSW
Country 44228 0
Australia
Phone 44228 0
+61247341474
Fax 44228 0
+61247341817
Email 44228 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.