Timing of Antibiotic Prophylaxis for Elective Cesarean Section: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- The primary outcome is the rate of post cesarean section surgical site infection.
研究概览
简要总结
A randomized controlled study comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.
详细描述
comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.on post-cesarean section infection(wound infection as a primary outcome)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective cesarean section with Gestational age 37 weeks or more
排除标准
- •Fever greater than 38°C or maternal sepsis.
- •Cephalosporin allergy.
- •Exposure to any antibiotic agent within 1week before delivery.
- •Patents having premature rupture of membranes and acute chorioamnionitis.
- •Patients with chronic diseases (diabetes mellitus, renal disease and Cardiac disease).
- •Morbid obesity (BMI>30)
研究组 & 干预措施
Group A ceftriaxone after cord clamping
165 patients pregnant at 37weeks or more undergoing elective cesarean section randomly distributed to receive
1 gm. ceftriaxone via l intravenous infusion single dose after cord clamping.
干预措施: ceftriaxone 1gm for intravenous infusion (Drug)
Group B ceftriaxone before skin incision
165 patients pregnant at 37weeks or more undergoing elective cesarean section randomly distributed to receive
1 gm. ceftriaxone vial intravenous infusion single dose 30-60 minutes before skin incision.
干预措施: ceftriaxone 1gm for intravenous infusion (Drug)
结局指标
主要结局
The primary outcome is the rate of post cesarean section surgical site infection.
时间窗: administration of 1gm ceftriaxone prophylaxis for elective cs and follow up surgical site infection till 40 days
postoperative assessment of SSI. Patients will be followed up at 48-72 hours postoperative, at 7th days (skin suture removal) and at 6 weeks (contraception application).all patients will be contacted by telephone and interviewed. They will be rescheduled for a clinic visit if they reported signs and symptoms of wound infection (purulent discharge or erythema \>1 cm in diameter, induration of the incision site and fever).
次要结局
- other post cesarean section maternal and neonatal infection(follow up ofother post cesarean section maternal and neonatal infection till 40 days of delivery)
研究者
AMR HELMY YEHIA
Lecturer in OB GYN
Ain Shams Maternity Hospital