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