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Trial registered on ANZCTR


Registration number
ACTRN12612001184864
Ethics application status
Approved
Date submitted
30/10/2012
Date registered
8/11/2012
Date last updated
9/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot randomised controlled trial of outpatient balloon catheter priming for induction of labour.
Scientific title
In low risk pregnant women undertaking cervical priming for induction of labour, where there is no evidence of maternal or fetal compromise, will outpatient management, in comparison to inpatient management, result in comparable clinical outcomes, interventions, maternal satisfaction and complications?
Secondary ID [1] 281469 0
Nil
Universal Trial Number (UTN)
U1111-1136-5067
Trial acronym
COPRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical priming 287726 0
Induction of labour 287727 0
Condition category
Condition code
Reproductive Health and Childbirth 288065 288065 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women in the experimental group having cervical priming for induction of labour will be allowed to go home after insertion of a balloon catheter, providing that a 20 minute cardiotocography (CTG) monitoring is satisfactory. They will return the next day for induction of labour, or for prostaglandin (PGE2) repriming. If they go into labour overnight or if there are any complications such as bleeding or rupture of membranes, they will return to the hospital overnight. Women in the control group will recieve the same management, except they will remain in hospital.
Intervention code [1] 285972 0
Treatment: Devices
Comparator / control treatment
Outpatient (experimental group) compared to inpatient management (control group). Inpatient management is standard care, with insertion of balloon catheter and CTG monitoring, then facilitation of overnight rest. Catheter is then removed the next morning, and induction of labour undertaken (as per outpatient management)
Control group
Active

Outcomes
Primary outcome [1] 288272 0
Oxytocin use
Timepoint [1] 288272 0
Casenote review, at end of pregnancy care
Primary outcome [2] 288273 0
Length of active labour
Timepoint [2] 288273 0
Casenote review, at end of pregnancy care
Primary outcome [3] 288274 0
Uterine hyperstimulation
Timepoint [3] 288274 0
Casenote review, at end of pregnancy care
Secondary outcome [1] 299737 0
Pain scores
Timepoint [1] 299737 0
After insertion of balloon catheter - visual analogue score
Secondary outcome [2] 299738 0
Anxiety scores
Timepoint [2] 299738 0
Specific questionairre, at end of pregnancy care
Secondary outcome [3] 299867 0
Maternal satisfaction
Timepoint [3] 299867 0
Specific questionairre, at end of pregnancy care
Secondary outcome [4] 299868 0
Economic assessment
Timepoint [4] 299868 0
Casenote review, at end of pregnancy care

Eligibility
Key inclusion criteria
Pregnancy is at term (37 completed weeks to 42 completed weeks. Intact membranes. Induction being performed for post-dates or social reason. Singleton, appropriately grown by clinical exam, cephalic presentation. (Clinical suspicion of growth restriction investigated by ultrasound assessment). -Cervical ripening for reasons other than fetal or maternal compromise.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Known intra uterine growth restriction (< 10th percentile for gestational age), suspected intra uterine growth restriction, Gestational Hypertension and Pre-Eclampsia.*Conditions specific to catheter priming including: placenta previa, low placenta, unDx vaginal bleeding, known latex allergy, active vaginal infection, active genital herpes.

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)
The woman and her attending clinician will decide that induction of labour is indicated. The clinician will perform a vaginal examination to decide whether cervical priming is
necessary. If the clinician feels that induction is necessary and she meets the eligibility criteria for the study, the woman will be referred to the research coordinator. The researcher (who is not involved in providing care) will then see her, and confirm her eligibility for the study. The trial will be explained and if she consents to participate, then the researcher will consent her into the trial. The woman will not be randomized until she is admitted for cervical priming.This computer generated randomization table will be generated and the randomization status will be designated in individual sequentially numbered sealed envelopes which are blinded to the researcher and participants until assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is 2:1 experimental to control stratified for primiparity and multiparity.
Thus, two randomization lists generated, allocation ratio of 2:1.
List for first time births (nulliparous) n=84.
List for women who have given birth before (parous) n=36.
Computer-generated list from: www.sealedenvelope.com
(to generate unequal allocation of 2:1, we needed to use the same treatment twice, ie: Group A, Group A, Group B. Block size divisible of sample size and treatment groups.
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
12/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286232 0
Charities/Societies/Foundations
Name [1] 286232 0
WCH foundation
Country [1] 286232 0
Australia
Primary sponsor type
Individual
Name
Dr Chris Wilkinson
Address
Women's and Children's Hospital
Perinatal Medicine
72 King William Rd
North Adelaide
South Australia
5006
Country
Australia
Secondary sponsor category [1] 285041 0
Individual
Name [1] 285041 0
Professor Deborah Turnbull
Address [1] 285041 0
Department of Psychology
University of Adelaide
North Terrace
Adelaide
5000
Country [1] 285041 0
Australia
Secondary sponsor category [2] 285042 0
Individual
Name [2] 285042 0
Pamela Adelson
Address [2] 285042 0
Department of Psychology
University of Adelaide
North Terrace
Adelaide
5000
Country [2] 285042 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288312 0
WCHN Human Research Ethics Comittee
Ethics committee address [1] 288312 0
Ethics committee country [1] 288312 0
Australia
Date submitted for ethics approval [1] 288312 0
Approval date [1] 288312 0
16/07/2012
Ethics approval number [1] 288312 0
REC2453/3/15

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

Contacts
Principal investigator
Name 34892 0
Address 34892 0
Country 34892 0
Phone 34892 0
Fax 34892 0
Email 34892 0
Contact person for public queries
Name 18139 0
Dr Chris Wilkinson
Address 18139 0
Perinatal Medicine
Women's and Children's Hospital
72 King William Rd
North Adelaide
South Australia
5006
Country 18139 0
Australia
Phone 18139 0
61 8 8161 7633
Fax 18139 0
61 8 8161 7654
Email 18139 0
chrisswilkinson@mac.com
Contact person for scientific queries
Name 9067 0
Dr Chris Wilkinson
Address 9067 0
Perinatal Medicine
Women's and Children's Hospital
72 King William Rd
North Adelaide
South Australia
5006
Country 9067 0
Australia
Phone 9067 0
61 8 8161 7633
Fax 9067 0
61 8 8161 7654
Email 9067 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.