Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000878976
Ethics application status
Approved
Date submitted
15/08/2011
Date registered
17/08/2011
Date last updated
22/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of an antenatal decision aid booklet on rate of vaginal birth after caesarean (VBAC) in women with previous caesarean section.
Scientific title
For pregnant women in the first half of their pregnancy with history of previous caesarean and eligible for vaginal birth after caesarean (VBAC), will using a decision aid increase their rate of VBAC compared to using a pamphlet?
Secondary ID [1] 262832 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pregnant women with previous caesarean section 270556 0
elective repeat caesarean section 270557 0
Vaginal Birth after Caesarean (VBAC) 270558 0
Condition category
Condition code
Reproductive Health and Childbirth 270720 270720 0 0
Antenatal care
Reproductive Health and Childbirth 270745 270745 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The decision aid is a comprehensive 25 page booklet that first explains the risks and benefits of elective repeat caesarean and of VBAC, and then asks the woman to write down her own values and preferences about the two birth options. It will be administered at the time of the consultation in the Positive Birth After Caesarean (PBAC) Clinic.
Intervention code [1] 269185 0
Prevention
Comparator / control treatment
The patient pamphlet is 6 pages and briefly lists risks and benefits of elective repeat caesarean and of VBAC. It is administered at the time of the consultation in PBAC clinic.
Control group
Active

Outcomes
Primary outcome [1] 269428 0
The rate of vaginal birth after caesarean (VBAC) is determined using the perinatal database at the hospital.
Timepoint [1] 269428 0
measured at time of baby's birth
Secondary outcome [1] 287620 0
mean decisional conflict score about birth choice, out of 5
Timepoint [1] 287620 0
measured at baseline (< 25 weeks gestation) and at follow-up (33-35 weeks gestation)
Secondary outcome [2] 287621 0
mean knowledge score about birth choices, out of 15
Timepoint [2] 287621 0
measured at baseline (< 25 weeks gestation) and at follow-up (33-35 weeks gestation)

Eligibility
Key inclusion criteria
history of one previous caesarean
less than 25 weeks gestation in current pregnancy
Minimum age
20 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
no consent to participate

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
none
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
univariate and multivariate models for logistic regression

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2011
Actual
19/11/2012
Date of last participant enrolment
Anticipated
Actual
14/07/2014
Date of last data collection
Anticipated
Actual
15/09/2014
Sample size
Target
314
Accrual to date
Final
300
Recruitment outside Australia
Country [1] 3788 0
New Zealand
State/province [1] 3788 0

Funding & Sponsors
Funding source category [1] 269657 0
Government body
Name [1] 269657 0
A+ Trust
Country [1] 269657 0
New Zealand
Primary sponsor type
Individual
Name
Dr Michelle Wise
Address
Department of Obstetrics and Gynaecology
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 266695 0
Other Collaborative groups
Name [1] 266695 0
Positive Birth After Caesarean working group
Address [1] 266695 0
c/o Dr Lynn Sadler and Dr Jenny McDougall
National Women's Health
Level 9, Support Building
Auckland City Hospital
2 Park Rd
Grafton
Auckland 1023
Country [1] 266695 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269605 0
National Health & Medical Research Council
Ethics committee address [1] 269605 0
Ethics committee country [1] 269605 0
Australia
Date submitted for ethics approval [1] 269605 0
01/09/2011
Approval date [1] 269605 0
Ethics approval number [1] 269605 0
Ethics committee name [2] 297756 0
Northern X Regional Ethics Committee
Ethics committee address [2] 297756 0
Health and Disability Ethics Committees
Private Bag 92522
Wellesley St
Auckland 1141
Ethics committee country [2] 297756 0
New Zealand
Date submitted for ethics approval [2] 297756 0
Approval date [2] 297756 0
09/01/2012
Ethics approval number [2] 297756 0
NTX/11/12/109

Summary
Brief summary
In 2010, the caesarean section rate at National Women’s in Auckland was 32%. The majority of caesareans were performed for women who have had a previous caesarean section. The alternative to a repeat caesarean is a Vaginal Birth after Caesarean (VBAC). Both methods of delivery have advantages and disadvantages, and current national guidelines recommend individualized decision-making. At National Women’s, only 40% of women try for a VBAC, and about 2 out of 3 women who try for VBAC will have a vaginal birth. The aim of this project is to increase the proportion of women with previous caesarean who have a vaginal birth. The clinical trial is aimed at women with previous caesarean who are in the first half of their pregnancy and deciding whether to plan a VBAC or repeat caesarean. They currently receive counselling about this decision by a midwife and obstetrician at the Positive Birth After Caesarean (PBAC) Clinic. Women will be randomized to use a newly developed decision aid booklet, or a patient education leaflet (routine care), as the basis for their counselling. All women will be asked prior to their consultation to complete questionnaires about knowledge and preferences about their birth options.We hypothesize that pregnant women who use the decision aid will have higher rates of vaginal birth, higher levels of knowledge, and lower levels of decisional conflict. Rates of vaginal birth will be determined using the perinatal database at the hospital. Levels of knowledge, decisional conflict and anxiety will be determined using validated published questionnaires. The overarching goal of the project is to improve quality of care at our hospital for the large number of women who have had a caesarean delivery.
Trial website
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 33018 0
Dr Michelle Wise
Address 33018 0
Department of Obstetrics and Gynaecology, FMHS
University of Auckland
Private Bag 92019
Auckland 1142
Country 33018 0
New Zealand
Phone 33018 0
+6499239488
Fax 33018 0
Email 33018 0
m.wise@auckland.ac.nz
Contact person for public queries
Name 16265 0
Dr Dr Michelle Wise
Address 16265 0
Department of Obstetrics and Gynaecology, FMHS
University of Auckland
Private Bag 92019
Auckland 1142
Country 16265 0
New Zealand
Phone 16265 0
64-9-923-9488
Fax 16265 0
Email 16265 0
m.wise@auckland.ac.nz
Contact person for scientific queries
Name 7193 0
Dr Dr Michelle Wise
Address 7193 0
Department of Obstetrics and Gynaecology, FMHS
University of Auckland
Private Bag 92019
Auckland 1142
Country 7193 0
New Zealand
Phone 7193 0
64-9-923-9488
Fax 7193 0
Email 7193 0
m.wise@auckland.ac.nz

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
EmbaseNon-clinical interventions for reducing unnecessary caesarean section.2018https://dx.doi.org/10.1002/14651858.CD005528.pub3
N.B. These documents automatically identified may not have been verified by the study sponsor.