Caesarean Section Surgical Techniques - A Randomised Factorial Trial.
| ISRCTN | ISRCTN11849611 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11849611 |
| Secondary identifying numbers | SEO030 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 01/12/2010
- 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
Dr Peter Brocklehurst
Scientific
Scientific
National Perinatal Epidemiology Unit
Institute of Health Sciences
Old Road
Oxford
OX3 7LF
United Kingdom
| Phone | +44 (0)1865 227000 |
|---|---|
| peter.brocklehurst@perinat.ox.ac.uk |
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 | Patient information can be found at: http://www.npeu.ox.ac.uk/caesar/caesar_downloads/detailedinfopages.pdf |
| Scientific title | |
| Study acronym | CAESAR |
| Study objectives | To evaluate alternative surgical techniques for 3 elements of caesarian section operation: single v double layer closure of the uterus; closure v non-closure of the pelvic peritoneum; liberal v restricted use of sub-rectus sheath drain. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pregnancy and childbirth: Childbirth |
| Intervention | 1. Single vs double layer closure of the uterus 2. Closure vs non-closure of the pelvic peritoneum 3. Liberal vs restricted use of sub-rectus sheath drain |
| Intervention type | Other |
| Primary outcome measure | Antibiotic use for febrile morbidity. |
| Secondary outcome measures | Endometritis; wound infection; operative procedures on wound; blood transfusion; breastfeeding at hospital discharge; severe or unexpected maternal morbidity; bladder function; cosmetic scar appearance |
| Overall study start date | 01/09/2000 |
| Completion date | 01/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 3500 |
| Key inclusion criteria | 3500 women undergoing delivery by their first lower segmental caesarean section |
| Key exclusion criteria | Under the age of 16 years |
| Date of first enrolment | 01/09/2000 |
| Date of final enrolment | 01/12/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
National Perinatal Epidemiology Unit
Oxford
OX3 7LF
United Kingdom
OX3 7LF
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive South East
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? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2010 | Yes | No |
