Prof. Victoria Eley1,2, Assoc Prof Severine Navarro3,4, Dr Elizabeth Martin5,6, Dr Akwasi Amoako1,2, Dr Gunter Hartel2,3, Ms Christine Woods1,2, Dr Yan Lu3,4, Prof Jeffrey Lipman2,7, Professor Jason Roberts2,8, Professor Mimi Tang9,10, Professor Leonie Callaway1,2
1The Royal Brisbane And Women's Hospital, Herston, Australia, 2The University of Queensland, Herston, Australia, 3QIMR Berghofer, Herston, Australia, 4Queensland University of Technology, Kelvin Grove , Australia, 5Wesley Research Institute, Toowong, Australia, 6Mater Research Institute, South Brisbane, Australia, 7Nimes University Hospital, University of Montpelier, France, 8Herston Infectious Diseases Institute, Metro North Health, Australia, 9Murdoch Children's Research Institute, Parkville, Australia, 10The University of Melbourne, Parkville, Australia
Biography:
Victoria Eley is the Professor and Head of the University of Queensland Mayne Academy of Critical Care. She is the Research Lead Anaesthetist at the Royal Brisbane and provides clinical services in adult and obstetric anaesthesia. Professor Eley is currently undertaking a Metro North Clinician Research Fellowship.
Abstract:
Introduction: Pre-incisional antibiotics are recommended for all patients having cesarean delivery,¹ despite emerging concerns regarding effects on the infant. In this feasibility blinded randomised controlled trial (RCT) we aimed to test research processes in low-risk women receiving cefazolin or placebo prior to elective cesarean delivery.
Methods: The trial was prospectively registered (ACTRN12619001705178). Eligible women were aged ≥ 18 and <40 years, ≥ 37 weeks gestation, at low risk of surgical site infection (SSI) and recruited from a single tertiary centre. We reported proportions of women eligible and consenting; adherence to perioperative infection prevention; blinding adequacy of staff using Bang’s blinding index; SSI surveillance and diagnosis according to the Centre for Disease Control definitions² and patient reported outcome measures (PROMs) using validated survey³ up to 90 days.
Results: We screened 1651 women, with 1245 (75%) ineligible based on BMI or presence of diabetes. Of 287 eligible women, 30 were randomised (11%) with 15 in each group. Reasons for non-participation included “wanting antibiotics” (68, 27%), “no reason” (62, 25%) and lack of research staff (33, 13%). Compliance with perioperative infection prevention occurred in 5 of 7 steps. Spontaneous placental separation occurred in 25 (83%) and Comfeel dressing in 29 (97%). Blinding was adequate for all staff groups. SSI surveillance occurred in 156 of 210 (74%) timepoints. SSI occurred in two patients who received pre-incisional cefazolin and were successfully treated as outpatients. PROM surveys were completed at 136 of 180 (76%) timepoints. There was no difference in maternal health-related quality of life between the groups.
Conclusions: Feasibility was impacted by the high-risk population and patient desire for antibiotics. Adherence to perioperative infection prevention practices were high but incomplete. These study processes could be effectively applied in a larger population, targeting non-tertiary maternity patients.
Keywords
Antibiotics, Cesarean delivery, Surgical site infection
References
1. Therapeutic Guidelines Ltd. Therapeutic guidelines: eTG complete 2021. Antibiotic: Surgical antibiotic prophylaxis for specific procedures. Available online at: https://tgldcdp-tg-org-au.ezproxy.library.uq.edu.au/quicklinks?type=Pregnancy%20and%20breastfeeding&bf=5a58609.htm (Accessed January 22, 2024)
2. Centre for Disease Control and Prevention. CDC Procedure-Associated Module SSI. (2019) Available online at: https://www.cdc.gov/nhsn/faqs/faq-ssi-proc-codes.html] Accessed January 22, 2024.
3. Cella D, Riley W, Stone A et al. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008. J Clin Epidemiol 2010; 63: 1179-94.