Prophylactic perioperative cefuroxime levels in plasma and adipose tissue at the time of caesarean section (C-LACE): a pilot experimental, prospective study with non-probability sampling to determine interpatient variability

niversity of Birmingham0 个研究点目标入组 30 人开始时间: 2020年10月26日最近更新: 2024年8月12日

适应症

试验速览

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33602323/ protocol (added 22/02/2021)

•1. Pregnant women 18 years to 50 years old, with a singleton pregnancy undergoing elective CS at 37 weeks or over
•2. Participant is able to give consent and agree to sample storage
•3. Participant agrees to be contacted for follow-up
•4. Participant contributing to the study needs to be able to read and/or understand English

•1. Multiple pregnancy
•2. Previous CS that resulted in a surgical site infection
•3. Emergency CS
•4. Any non-elective CS including those requiring early delivery without threat to maternal or foetal health that were not previously planned
•5. Body Mass Index (BMI) less than 18 kg/m2 or greater than or equal to 45 kg/m2 (at time of first pregnancy appointment and at time of delivery)
•6. Participant contributing to the study is unable to read and/or understand English
•7. Currently enrolled in a randomized controlled trial for an intervention to reduce postoperative surgical site infection
•8. Diabetes (type 1, type 2 or gestational)
•9. Hypertension
•10. Renal disease
•11. Cardiovascular disease (e.g. maternal structural cardiac disease)
•12. Liver disease
•13. Inflammatory bowel disease (e.g. Crohn’s disease or ulcerative colitis)
•14. Cephalosporin or penicillin allergy
•15. Administration of antibiotic within 1 week prior to delivery
•16. Suspected pre-existing infection (including chorioamnionitis)
•17. Autoimmune disease (e.g. systemic lupus erythematosus, rheumatoid arthritis)
•18. Chronic use of corticosteroid
•19. History of wound breakdown in an abdominal surgery
•20. Prior laparotomy for any indication (e.g. Previous ovarian cystectomy or previous bowel surgery)

发起方