Cefazolin versus placebo for surgical antibiotic prophylaxis in low-risk cesarean delivery: a feasibility blinded randomized controlled trial
Abstract Background Pre-incisional antibiotics are recommended for all patients having cesarean delivery, despite emerging concerns regarding effects on the infant. In this feasibility blinded randomized controlled trial we aimed to test research processes in low-risk women receiving cefazolin or pl...
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2025-03-01
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| Series: | BMC Pregnancy and Childbirth |
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| Online Access: | https://doi.org/10.1186/s12884-025-07484-5 |
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| author | Victoria A. Eley Severine Navarro Elizabeth Martin Akwasi Amoako Gunter Hartel Christine Woods Yan Lu Jeffrey Lipman Jason Roberts Mimi Tang Leonie Callaway |
| author_facet | Victoria A. Eley Severine Navarro Elizabeth Martin Akwasi Amoako Gunter Hartel Christine Woods Yan Lu Jeffrey Lipman Jason Roberts Mimi Tang Leonie Callaway |
| author_sort | Victoria A. Eley |
| collection | DOAJ |
| description | Abstract Background Pre-incisional antibiotics are recommended for all patients having cesarean delivery, despite emerging concerns regarding effects on the infant. In this feasibility blinded randomized controlled trial 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 definitions and patient reported outcome measures using validated questionnaires up to 90 days. Results We screened 1651 women, with 1245 (75%) ineligible based on body mass index or presence of diabetes. Of 287 eligible women, 30 were randomized (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. Patient reported outcome questionnaires 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 low risk maternity patients. Trial registration Prospectively registered 4/12/2019 with the Australian New Zealand Clinical Trials Registry (ACTRN12619001705178). |
| format | Article |
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| institution | Kabale University |
| issn | 1471-2393 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | BMC |
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| series | BMC Pregnancy and Childbirth |
| spelling | doaj-art-2d003bbe17394f75bf6dbe5b666553192025-08-20T03:40:48ZengBMCBMC Pregnancy and Childbirth1471-23932025-03-0125111110.1186/s12884-025-07484-5Cefazolin versus placebo for surgical antibiotic prophylaxis in low-risk cesarean delivery: a feasibility blinded randomized controlled trialVictoria A. Eley0Severine Navarro1Elizabeth Martin2Akwasi Amoako3Gunter Hartel4Christine Woods5Yan Lu6Jeffrey Lipman7Jason Roberts8Mimi Tang9Leonie Callaway10Department of Anaesthesia and Perioperative Medicine, The Royal Brisbane and Women’s HospitalMucosal Immunology, QIMR Berghofer Medical Research InstituteWesley Research InstituteMedical School, Faculty of Medicine, The University of QueenslandStatistics Unit, QIMR Berghofer Medical Research InstituteDepartment of Anaesthesia and Perioperative Medicine, The Royal Brisbane and Women’s HospitalMucosal Immunology, QIMR Berghofer Medical Research InstituteMedical School, Faculty of Medicine, The University of QueenslandCentre for Clinical Research, Faculty of Medicine, University of Queensland, The University of QueenslandAllergy Immunology, Murdoch Children’s Research InstituteMedical School, Faculty of Medicine, The University of QueenslandAbstract Background Pre-incisional antibiotics are recommended for all patients having cesarean delivery, despite emerging concerns regarding effects on the infant. In this feasibility blinded randomized controlled trial 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 definitions and patient reported outcome measures using validated questionnaires up to 90 days. Results We screened 1651 women, with 1245 (75%) ineligible based on body mass index or presence of diabetes. Of 287 eligible women, 30 were randomized (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. Patient reported outcome questionnaires 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 low risk maternity patients. Trial registration Prospectively registered 4/12/2019 with the Australian New Zealand Clinical Trials Registry (ACTRN12619001705178).https://doi.org/10.1186/s12884-025-07484-5AllergyAntibioticsAtopyCesarean deliverySurgical prophylaxisSurgical site infection |
| spellingShingle | Victoria A. Eley Severine Navarro Elizabeth Martin Akwasi Amoako Gunter Hartel Christine Woods Yan Lu Jeffrey Lipman Jason Roberts Mimi Tang Leonie Callaway Cefazolin versus placebo for surgical antibiotic prophylaxis in low-risk cesarean delivery: a feasibility blinded randomized controlled trial BMC Pregnancy and Childbirth Allergy Antibiotics Atopy Cesarean delivery Surgical prophylaxis Surgical site infection |
| title | Cefazolin versus placebo for surgical antibiotic prophylaxis in low-risk cesarean delivery: a feasibility blinded randomized controlled trial |
| title_full | Cefazolin versus placebo for surgical antibiotic prophylaxis in low-risk cesarean delivery: a feasibility blinded randomized controlled trial |
| title_fullStr | Cefazolin versus placebo for surgical antibiotic prophylaxis in low-risk cesarean delivery: a feasibility blinded randomized controlled trial |
| title_full_unstemmed | Cefazolin versus placebo for surgical antibiotic prophylaxis in low-risk cesarean delivery: a feasibility blinded randomized controlled trial |
| title_short | Cefazolin versus placebo for surgical antibiotic prophylaxis in low-risk cesarean delivery: a feasibility blinded randomized controlled trial |
| title_sort | cefazolin versus placebo for surgical antibiotic prophylaxis in low risk cesarean delivery a feasibility blinded randomized controlled trial |
| topic | Allergy Antibiotics Atopy Cesarean delivery Surgical prophylaxis Surgical site infection |
| url | https://doi.org/10.1186/s12884-025-07484-5 |
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