Condition category
Pregnancy and Childbirth
Date applied
06/09/2005
Date assigned
05/10/2005
Last edited
07/02/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Caroline Crowther

ORCID ID

Contact details

University of Adelaide
Women's & Children's Hospital
72 King William Road
North Adelaide
5006
Australia
+61 (0)8 8161 7647
caroline.crowther@adelaide.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

BAC

Study hypothesis

For women who meet eligibility criteria for a planned VBAC there is no difference in the risk of death or serious adverse outcome for the infant in women who have a planned VBAC compared with planned elective repeat caesarean.

As of 02/02/2012, target number of participants updated from 2180 (including patient preference and RCT arms) to 2314 (including patient preference and RCT arms and allowing for a small 1% loss to follow-up).

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Birth after previous caesarean

Intervention

Eligible women will be randomised to either planned vaginal birth after caesarean or planned elective repeat caesarean section or can be entered into their preferred treatment group (patient preference study)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Neonatal lung disease
2. Serious neonatal mobidity
3. Perinatal/neonatal mortality

Secondary outcome measures

Secondary outcome(s) for funded study as of 2005:
1. Serious adverse outcomes for the women (up to time of primary hospital discharge)

Secondary outcomes for pre-funding draft protocol:
1. Serious adverse outcomes for the women
2. Maternal physical wellbeing
3. Maternal emotional wellbeing
4. Costs of health care for the infant

Overall trial start date

28/03/2003

Overall trial end date

07/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Women with a single prior caesarean presenting in their next pregnancy with a single live fetus in cephalic presentation who have reached 37 weeks gestation, and who don't have a contraindication to a planned VBAC.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

2314 (including patient preference and RCT arms and allowing for a small 1% loss to follow-up)

Participant exclusion criteria

Women with more than 1 prior caesarean; vertical inverted T or unknown uterine incision; previous uterine rupture; previous uterine surgery (hysterotomy) or myomectomy with entry into uterine cavity; previous uterine perforation; multiple pregnancy; any contraindication to vaginal birth; cephalo-pelvic disproportion; lethal congenital anomaly; fetal anomaly associated with mechanical difficulties at delivery.

Recruitment start date

28/03/2003

Recruitment end date

07/01/2008

Locations

Countries of recruitment

Australia

Trial participating centre

University of Adelaide
North Adelaide
5006
Australia

Sponsor information

Organisation

The University of Adelaide (Australia)

Sponsor details

North Terrace
Adelaide
5005
Australia
+61 (0)8 8161 7647
caroline.crowther@adelaide.edu.au

Sponsor type

University/education

Website

http://www.adelaide.edu.au/

Funders

Funder type

Research council

Funder name

Australian National Health and Medical Research Council (NHMRC)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Protocol on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17697343

Publication citations

  1. Protocol

    Dodd JM, Crowther CA, Hiller JE, Haslam RR, Robinson JS, Birth after caesarean study--planned vaginal birth or planned elective repeat caesarean for women at term with a single previous caesarean birth: protocol for a patient preference study and randomised trial., BMC Pregnancy Childbirth, 2007, 7, 17, doi: 10.1186/1471-2393-7-17.

Additional files

Editorial Notes