Condition category
Pregnancy and Childbirth
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
01/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.npeu.ox.ac.uk/caesar/

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes