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 |
| Protocol serial number | N/A |
| Sponsor | The University of Adelaide (Australia) |
| Funder | Australian National Health and Medical Research Council (NHMRC) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
University of Adelaide
Women's & Children's Hospital
72 King William Road
North Adelaide
5006
Australia
| Phone | +61 (0)8 8161 7647 |
|---|---|
| caroline.crowther@adelaide.edu.au |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
1. Neonatal lung disease |
| Key secondary outcome measure(s) |
Secondary outcome(s) for funded study as of 2005: |
| Completion date | 07/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 2314 |
| 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
5006
Australia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2012 | 07/01/2021 | Yes | No |
| Protocol article | protocol | 14/08/2007 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
