ANZCTR - Registration

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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]

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

elective repeat caesarean section

Vaginal Birth after Caesarean (VBAC)

Condition category

Condition code

Reproductive Health and Childbirth

Antenatal care

Reproductive Health and Childbirth

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]

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]

The rate of vaginal birth after caesarean (VBAC) is determined using the perinatal database at the hospital.

Timepoint [1]

measured at time of baby's birth

Secondary outcome [1]

mean decisional conflict score about birth choice, out of 5

Timepoint [1]

measured at baseline (< 25 weeks gestation) and at follow-up (33-35 weeks gestation)

Secondary outcome [2]

mean knowledge score about birth choices, out of 15

Timepoint [2]

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]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

A+ Trust

Address [1]

ADHB Research Office
Level 14, Support Building
Auckland City Hospital
2 Park Rd
Grafton
Auckland 1023

Country [1]

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]

Other Collaborative groups

Name [1]

Positive Birth After Caesarean working group

Address [1]

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]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

National Health & Medical Research Council

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/09/2011

Approval date [1]

Ethics approval number [1]

Ethics committee name [2]

Northern X Regional Ethics Committee

Ethics committee address [2]

Health and Disability Ethics Committees 
Private Bag 92522
Wellesley St
Auckland 1141

Ethics committee country [2]

New Zealand

Date submitted for ethics approval [2]

Approval date [2]

09/01/2012

Ethics approval number [2]

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

Dr Michelle Wise

Address

Department of Obstetrics and Gynaecology, FMHS
University of Auckland
Private Bag 92019
Auckland 1142

Country

New Zealand

Phone

+6499239488

Fax

m.wise@auckland.ac.nz

Contact person for public queries

Name

Dr Michelle Wise

Address

Department of Obstetrics and Gynaecology, FMHS
University of Auckland
Private Bag 92019
Auckland 1142

Country

New Zealand

Phone

64-9-923-9488

Fax

m.wise@auckland.ac.nz

Contact person for scientific queries

Name

Dr Michelle Wise

Address

Department of Obstetrics and Gynaecology, FMHS
University of Auckland
Private Bag 92019
Auckland 1142

Country

New Zealand

Phone

64-9-923-9488

Fax

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

Source	Title	Year of Publication	DOI
Embase	Non-clinical interventions for reducing unnecessary caesarean section.	2018	https://dx.doi.org/10.1002/14651858.CD005528.pub3

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically