Antibiotic (cefuroxime) levels after caesarean sectio

Not Applicable

• Conditions: 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

• Registration Number: ISRCTN17527512
• Lead Sponsor: niversity of Birmingham

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-26
• Last Update Posted: 12 August 2024
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 30

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

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.