Cefuroxime concentration in plasma and adipose tissue (within the incision) at time of skin incision and skin closure in obese and non-obese pregnant patients requiring caesarean section Infections and Infestations
Conditions
Interventions
This study will measure the concentration of cefuroxime in adipose tissue (two samples from site of incision) and blood (three samples) from pregnant women undergoing scheduled caesarean section. Anal
Sponsors
University of Birmingham
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time above the Minimum Inhibitory Concentrations (T>MIC): the MIC is not harmonised between guidelines, thus the time above the T>MIC will be reported for MIC values of 1, 4 and 8 mg/l as these values correlate to the most common bacteria involves in post-CS surgical infections. The analytical method used to measure cefuroxime is LC-MS/MS (Liquid Chromatography with tandem mass spectrometry). At time of caesarean section, five samples will be collected: one blood sample at time of skin incision, one blood sample at time of skin closure, one blood sample at recovery room (<3 hours following CS), one adipose tissue sample (approximately 1 cm from the skin in the middle of the Pfannenstiel or vertical midline incision) at skin incision and one adipose tissue sample (from a similar location to sample 1) just prior to skin closure. | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of surgical site infection as per the definitions set out by the US Centers for Disease Control and Prevention (2019). The participants will be contacted at 30-40 days post-CS to record any incidence of infection occurred from day 1 of CS until the time of the contact. | — |
Countries
England, United Kingdom
Contacts
Public ContactHanadi Alrammaal
Outcome results
None listed