Background
Antibiotics before cesarean delivery are generally recommended for all patients, but there are concerns about their effects on infants. This study tested the processes of a clinical trial involving low-risk women receiving either cefazolin (an antibiotic) or a placebo before elective cesarean delivery.
Methods
The trial was registered and included women aged 18 to 39, at least 37 weeks pregnant, and at low risk of surgical site infections (SSI). We looked at how many women were eligible and agreed to participate, adherence to infection prevention measures, the effectiveness of blinding, and SSI occurrences based on health guidelines.
Results
Out of 1651 women screened, 1245 (75%) were not eligible due to factors like body mass index or diabetes. Of the 287 eligible women, only 30 (11%) agreed to participate, with 15 receiving cefazolin and 15 receiving a placebo. Reasons for not participating included a preference for antibiotics (27%) and no specific reasons given (25%).
Adherence to infection prevention practices was high but not complete. Spontaneous placental separation occurred in 25 women (83%), and 29 (97%) used a specific dressing correctly. Blinding was effective across all staff. SSI monitoring happened for 156 out of 210 (74%) scheduled checks, with two cases of SSI in the cefazolin group, both treated successfully as outpatients.
Patient surveys were completed at 136 out of 180 (76%) times. No significant difference in maternal health-related quality of life was found between the two groups.
Conclusions
The study’s feasibility was affected by the high-risk nature of the population and patients’ preference for antibiotics. While adherence to infection prevention was generally good, there were areas for improvement. These processes could be adapted for larger groups of low-risk maternity patients.
Opportunities Based on Trial Data
1. Define Measurable Outcomes: Set clear goals for comparing cefazolin versus placebo in low-risk cesarean delivery.
2. Select AI Tools: Choose AI solutions that meet specific clinical needs related to antibiotic use in cesarean deliveries.
3. Implement Step by Step: Start with a pilot project, track the results, and assess the real-world impact of the findings.
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