Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Peter Brocklehurst
ORCID ID
Contact details
National Perinatal Epidemiology Unit
Institute of Health Sciences
Old Road
Oxford
OX3 7LF
United Kingdom
+44 (0)1865 227000
peter.brocklehurst@perinat.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SEO030
Study information
Scientific title
Acronym
CAESAR
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Patient information can be found at: http://www.npeu.ox.ac.uk/caesar/caesar_downloads/detailedinfopages.pdf
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/09/2000
Overall trial end date
01/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
3500 women undergoing delivery by their first lower segmental caesarean section
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
3500
Participant exclusion criteria
Under the age of 16 years
Recruitment start date
01/09/2000
Recruitment end date
01/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
National Perinatal Epidemiology Unit
Oxford
OX3 7LF
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive South East
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20840692
Publication citations
-
Results
Caesarean section surgical techniques: a randomised factorial trial (CAESAR)., BJOG, 2010, 117, 11, 1366-1376, doi: 10.1111/j.1471-0528.2010.02686.x.