Caesarean Section Surgical Techniques - A Randomised Factorial Trial.
| ISRCTN | ISRCTN11849611 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11849611 |
| Protocol serial number | SEO030 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive South East |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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(s) |
Antibiotic use for febrile morbidity. |
| Key secondary outcome measure(s) |
Endometritis; wound infection; operative procedures on wound; blood transfusion; breastfeeding at hospital discharge; severe or unexpected maternal morbidity; bladder function; cosmetic scar appearance |
| Completion date | 01/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
National Perinatal Epidemiology Unit
Oxford
OX3 7LF
United Kingdom
OX3 7LF
United Kingdom
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 | 01/10/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
