Efficacy of adjuvent Azithromycin and 3rd generation cephalosporin to prevent post cessarean SSI: A randomized control non inferiority trial
概览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- To compare the incidence of SSI between prophylactic combination of ceftriaxone and azithromycin and prophylactic combination ceftriaxone and cefuroxime in Indian pregnant women undergoing c-section
概览
简要总结
The study investigates the efficacy of combining ceftriaxone and azithromycin as a prophylactic regimen for preventing surgical site infections (SSIs) post-cesarean section compared to ceftriaxone and cefuroxime. Rising cesarean rates and associated SSIs highlight the need for improved preventive strategies. Ceftriaxone targets skin flora but has limitations against fastidious vaginal pathogens. Azithromycin complements it by covering organisms like *Ureaplasma* and *Mycoplasma*, associated with endometritis and UTIs. This randomized controlled trial aims to assess infection rates, severity, and neonatal outcomes. If successful, it will provide evidence for cost-effective, enhanced prophylaxis tailored to Indian women undergoing cesarean delivery.
This two-arm, open label randomized controlled trial will be conducted at AIIMS Patna OBGYN department from January 2025 to January 2026. The study population includes Indian pregnant women aged 18–45 years at ≥28 weeks gestation undergoing cesarean sections. Eligible participants must meet inclusion criteria (e.g., no allergy to ceftriaxone or azithromycin) and will be randomized into two groups using block randomization and SNOSE for blinding.
Group 1 (Control): Ceftriaxone 1g IV preoperatively + Cefuroxime 500 mg orally for 5 days.
Group 2 (Intervention): Ceftriaxone 1g IV + Azithromycin 500 mg IV preoperatively, with an additional azithromycin dose if blood loss exceeds 1500 ml.
The sample size will include 178 participants (89 per group) based on a non-inferiority margin and previous studies. Consecutive sampling will ensure enrollment. Data will be analyzed using an intention-to-treat (ITT) approach, with blinding maintained for participants and outcome assessors. The study will evaluate the effectiveness of the intervention in reducing SSIs and related complications. The analysis will be done as per intention to treat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Undergoing c-section No History of allergy for ceftriaxone and azithromycin.
排除标准
- •Use of antibiotics in the last 7 days of c-section.
- •Known allergy to any of the study antibiotics.
- •Ruptured membranes for more than 24 h or at place other than the hospital Evidence of infection or fever, preoperatively or during surgery Women with any comorbidity, e.g., overt DM, TB, any heart disease, or any chronic illness.
- •Preop hemoglobin less than 7g/dl.
结局指标
主要结局
To compare the incidence of SSI between prophylactic combination of ceftriaxone and azithromycin and prophylactic combination ceftriaxone and cefuroxime in Indian pregnant women undergoing c-section
时间窗: 7 days, 14 days, 30 days, 42 days
次要结局
- 1. To compare severity, time to develop surgical site infection between two groups.(2. To compare severity of SSI between 2 groups.)
研究者
PURNIMA SAGAR
AIIMS PATNA