Birth After Caesarean - Planned vaginal birth or planned caesarean section for women at term with a single previous caesarean birth

ISRCTN	ISRCTN53974531
DOI	https://doi.org/10.1186/ISRCTN53974531
Secondary identifying numbers	N/A

Submission date: 06/09/2005
Registration date: 05/10/2005
Last edited: 07/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Caroline Crowther
Scientific

University of Adelaide
Women's & Children's Hospital
72 King William Road
North Adelaide
5006
Australia

Phone	+61 (0)8 8161 7647
Email	caroline.crowther@adelaide.edu.au

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Birth After Caesarean - Planned vaginal birth or planned caesarean section for women at term with a single previous caesarean birth
Study acronym	BAC
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	28/03/2003
Completion date	07/01/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	2314 (including patient preference and RCT arms and allowing for a small 1% loss to follow-up)
Total final enrolment	2345
Key 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.
Key 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.
Date of first enrolment	28/03/2003
Date of final enrolment	07/01/2008

Locations

Countries of recruitment

Australia

Study participating centre

University of Adelaide

North Adelaide
5006
Australia

Sponsor information

The University of Adelaide (Australia)
University/education

North Terrace
Adelaide
5005
Australia

Phone	+61 (0)8 8161 7647
Email	caroline.crowther@adelaide.edu.au
Website	http://www.adelaide.edu.au/
"ROR"	https://ror.org/00892tw58

Funders

Funder type

Research council

Australian National Health and Medical Research Council (NHMRC)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	14/08/2007		Yes	No
Results article	results	01/08/2012	07/01/2021	Yes	No

Editorial Notes

02/02/2012: The 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).
07/01/2021: Publication reference and total final enrolment added.