International study of caesarean section surgical techniques: a randomised fractional factorial trial and follow-up study
Completed
- Conditions
- Pregnancy and ChildbirthCaesarean section techniques
- Registration Number
- ISRCTN31089967
- Lead Sponsor
- niversity of Oxford (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 15729
Inclusion Criteria
Women will be eligible for trial entry if they are undergoing delivery by lower segment caesarean section through a transverse abdominal incision.
Note: women are eligible if they have had no previous, or one previous, caesarean section. Fever in labour is not a contra-indication to trial entry.
Added as of 13/03/2013: All women recruited into the CORONIS Trial and eligible for three year follow-up will have a health assessment conducted by a study assessment doctor.
Exclusion Criteria
Women will not be eligible for trial entry if there is clear indication for a particular surgical technique or material to be used, that interferes with any of the allocated interventions, e.g. in a previous vertical incision.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Current information as of 29/09/10:<br>Death or maternal infectious morbidity (one or more of the following: antibiotic use for maternal febrile morbidity during postnatal hospital stay, antibiotic use for endometritis, wound infection or peritonitis) or further operative procedures; or blood transfusion of >1 unit of whole blood or packed cells.<br><br>Initial information at time of registration:<br>Death or serious maternal morbidity (one or more of the following: antibiotic use for maternal febrile morbidity during postnatal hospital stay, antibiotic use for endometritis or wound infection; further operative procedures on the wound; blood transfusion).
- Secondary Outcome Measures
Name Time Method