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Birth After Caesarean - Planned vaginal birth or planned caesarean section for women at term with a single previous caesarean birth
ISRCTN ISRCTN53974531
ClinicalTrials.gov identifier
Public title Birth After Caesarean - Planned vaginal birth or planned caesarean section for women at term with a single previous caesarean birth
Scientific title
Acronym BAC
Serial number at source N/A
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).
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Australia
Disease/condition/study domain Birth after previous caesarean
Participants - 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.
Participants - 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.
Anticipated start date 28/03/2003
Anticipated end date 07/01/2008
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 2314 (including patient preference and RCT arms and allowing for a small 1% loss to follow-up)
Interventions 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)
Primary outcome measure(s) 1. Neonatal lung disease
2. Serious neonatal mobidity
3. Perinatal/neonatal mortality
Secondary outcome measure(s) 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
Sources of funding Australian National Health and Medical Research Council (NHMRC)
Trial website
Publications Protocol on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17697343
Contact name Prof  Caroline  Crowther
  Address University of Adelaide
Women's & Children's Hospital
72 King William Road
  City/town North Adelaide
  Zip/Postcode 5006
  Country Australia
  Tel +61 (0)8 8161 7647
  Fax +61 (0)8 8161 7652
  Email caroline.crowther@adelaide.edu.au
Sponsor The University of Adelaide (Australia)
  Address North Terrace
  City/town Adelaide
  Zip/Postcode 5005
  Country Australia
  Tel +61 (0)8 8161 7647
  Fax +61 (0)8 8161 7652
  Email caroline.crowther@adelaide.edu.au
  Sponsor website http://www.adelaide.edu.au/
Date applied 06/09/2005
Last edited 07/02/2012
Date ISRCTN assigned 05/10/2005