Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000249358
Ethics application status
Approved
Date submitted
13/05/2008
Date registered
15/05/2008
Date last updated
13/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of outpatient cervical priming for induction of labour
Scientific title
A multicentre randomised controlled trial comparing outpatient and inpatient cervical priming with intravaginal prostaglandins for induction of labour
Secondary ID [1] 560 0
National Health and Medical Research Council ID: 519236
Universal Trial Number (UTN)
Trial acronym
OPRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Outpatient management of the initiation of induction of labour in pregnant woman 3142 0
Condition category
Condition code
Reproductive Health and Childbirth 3301 3301 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cervical priming with maternal and fetal monitoring prior to induction of labour in a hospital antenatal assessment area, followed by discharge home for no more than 24 hours of pregnant women - comparison with inpatient management of priming for induction of labour (usual care) of pregnant women.
Intervention code [1] 2879 0
Other interventions
Comparator / control treatment
Outpatient management and monitoring compared to inpatient management and monitoring
Control group
Active

Outcomes
Primary outcome [1] 4188 0
Syntocinon usage (review of labour records of timing, amount and duration)
Timepoint [1] 4188 0
Subsequent labour and delivery
Primary outcome [2] 4189 0
Obstetric interventions (review of labour records of caesarean section rates, instrumental delivery rates, analgesia used etc.)
Timepoint [2] 4189 0
Subsequent labour, delivery and postnatal course (up to 6 weeks post natal)
Primary outcome [3] 4190 0
Pregnancy complication
Timepoint [3] 4190 0
Subsequent labour, delivery and post natal course (from medical records and interview/written survey at 6 weeks)
Secondary outcome [1] 7081 0
Economic evaluation (discrete choice experiment plus resource usage evaluation)
Timepoint [1] 7081 0
Subsequent labour and delivery and post natal course (up to 6 weeks postnatal)
Secondary outcome [2] 7082 0
Maternal satisfaction / psychosocial outcomes (EPDS, other written survey methods, interviews)
Timepoint [2] 7082 0
Subsequent labour and delivery and postnatal course (up to 6 weeks post natal)
Secondary outcome [3] 7083 0
Caregiver satisfaction / psychosocial outcomes (interviews plus written questionairre)
Timepoint [3] 7083 0
Before and after initiation of intervention

Eligibility
Key inclusion criteria
All women of reproductive age having priming for induction of labour, where induction is clinically indicated, there is no evidence of maternal or fetal compromise and in the opinion of the referring caregiver, outpatient management and monitoring is clinically appropriate
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Maternal or fetal compromise. or in the opinion of the referring clinician, inpatient management and monitoring is clinically indicated

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)
Referral from a clinician deciding that induction is necessary during the process of antenatal care. A research officer checks eligibility and initiates randomisation from an off site randomisation centre. Randomisation is not blinded by the nature of the intervention
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation blocks stratified to site of intervention and parity
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
Completed
Date of first participant enrolment
Anticipated
1/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 675 0
5006
Recruitment postcode(s) [2] 676 0
5000
Recruitment postcode(s) [3] 677 0
5042

Funding & Sponsors
Funding source category [1] 3377 0
Government body
Name [1] 3377 0
National Health and Medical Research Council
Country [1] 3377 0
Australia
Primary sponsor type
Individual
Name
Dr Chris Wilkinson
Address
Women's and Children's Hospital
72 King William Rd
North Adelaide
South Australia 5006
Country
Australia
Secondary sponsor category [1] 3021 0
Individual
Name [1] 3021 0
Professor Deborah Turnbull
Address [1] 3021 0
School of Psychology
University of Adelaide
North Terrace
Adelaide 5000
Country [1] 3021 0
Australia
Other collaborator category [1] 282 0
Individual
Name [1] 282 0
Professor Philip Ryan
Address [1] 282 0
Department of Public Health
University of Adelaide
North Terrace
Adelaide 5000
Country [1] 282 0
Australia
Other collaborator category [2] 283 0
Individual
Name [2] 283 0
Assoc Professor Robert Bryce
Address [2] 283 0
Clinical Director of Obstetrics and Gynaecology Centre for Perinatal Medicine
Flinders Medical Centre
Bedford Park 5042
South Australia
Country [2] 283 0
Australia
Other collaborator category [3] 284 0
Individual
Name [3] 284 0
Dr Karen Gerard
Address [3] 284 0
Reader in Health Economics
University of Southampton
Country [3] 284 0
United Kingdom
Other collaborator category [4] 285 0
Individual
Name [4] 285 0
Dr Georgina Stamp
Address [4] 285 0
Research Fellow
University of South Australia
Country [4] 285 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5403 0
CYWHS Research Ethics Committee
Ethics committee address [1] 5403 0
Ethics committee country [1] 5403 0
Australia
Date submitted for ethics approval [1] 5403 0
Approval date [1] 5403 0
Ethics approval number [1] 5403 0
REC2034/2/11

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

Contacts
Principal investigator
Name 28584 0
Address 28584 0
Country 28584 0
Phone 28584 0
Fax 28584 0
Email 28584 0
Contact person for public queries
Name 11741 0
Ms Pamela Adelson
Address 11741 0
School of Psychology
University of Adelaide
North Terrace
Adelaide 5000
Country 11741 0
Australia
Phone 11741 0
0401193809
Fax 11741 0
Email 11741 0
pamela.adelson@qmail.com
Contact person for scientific queries
Name 2669 0
Dr Chris Wilkinson
Address 2669 0
Department of Perinatal Medicine
Women's and Children's Hospital
72 King William Rd
North Adelaide 5006
South Australia
Country 2669 0
Australia
Phone 2669 0
0412 883336
Fax 2669 0
8161 7654
Email 2669 0
chrisswilkinson@mac.com

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.