Azithromycin-based Extended-spectrum Prophylaxis in Scheduled Cesarean Deliveries
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Rates of Endometritis
研究概览
简要总结
Cesarean deliveries are the most common surgical procedure performed in the United States. A significant decrease in cesarean delivery associated maternal morbidity has been achieved with preoperative prophylactic single-dose cephalosporin, widely used before skin incision. Also, on laboring patients and/or with rupture of membranes, several studies suggest that adding azithromycin to standard cephalosporin prophylaxis is cost-effective and reduces overall rates of endometritis, wound infection, readmission, use of antibiotics and serious maternal events. Azithromycin has effective coverage against Ureaplasma, associated with increased rates of endometritis. Although two-drug regimen has been suggested for laboring and/or patients that undergo cesarean delivery, no studies have investigated the potential benefits of two-drug regimen in non-laboring patients.
详细描述
Cesarean deliveries are the most common surgical procedure performed in the United States, and scheduled cesarean deliveries account for at least 40% of all cesarean deliveries every year. A significant decrease in cesarean delivery associated maternal morbidity has been achieved with preoperative prophylactic single-dose cephalosporin given within 60 minutes of skin incision. Also, on laboring patients and/or with rupture of membranes, several studies suggest that adding azithromycin to standard cephalosporin prophylaxis is not only cost-effective but reduces overall rates of endometritis and wound infection. Azithromycin provides effective coverage against Ureaplasma, commonly associated with increased rates of endometritis. Although two-drug regimen has been suggested for laboring and/or patients that undergo cesarean delivery, no studies have investigated the potential benefits of two-drug regimen in non-laboring patients. No increase in neonatal morbidity was noted with adjunctive azithromycin prophylaxis, including adverse events.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women 18 years or older
- •Women undergoing primary or repeat cesarean delivery
- •Singleton gestation
- •Gestational age greater than 34 weeks
- •Pregnant patients undergoing scheduled cesarean delivery
- •Intact membranes
- •Non-laboring
- •Signed informed consent
排除标准
- •Maternal age < 18 years
- •Multi-fetal gestation
- •Known allergy to cephalosporin or azithromycin
- •Patient unwilling or unable to provide consent
- •Diagnosis of rupture of membranes
- •Intraamniotic infection, or any other active bacterial infection (e.g. pyelonephritis, pneumonia, abscess) at time of randomization.
- •Immunocompromising medical conditions: HIV positive with CD4 count below 200, chronic steroid use, current diagnosis of cancer and/or chemotherapy age use
- •Emergent cesarean precluding consent or availability of study medication
- •Need for hysterectomy at time of delivery
- •Use of antibiotic in the 72 hours prior to admission, with exception to patient receiving antibiotics for GBS
- •Inability to contact patient on postpartum period.
研究组 & 干预措施
One-drug Prophylaxis
Mefoxin 2g IV, Piggyback, once
干预措施: Mefoxin 2g (Drug)
Two-drug Prophylaxis
Mefoxin 2g IV, Piggyback, once and Azithromycin 500mg IV, Piggyback, once
干预措施: Azithromycin 500 mg (Drug)
Two-drug Prophylaxis
Mefoxin 2g IV, Piggyback, once and Azithromycin 500mg IV, Piggyback, once
干预措施: Mefoxin 2g (Drug)
结局指标
主要结局
Rates of Endometritis
时间窗: Up to 6 weeks after delivery
Presence of at least two of the following signs with no other recognized cause: fever (temperature of at least 38°C \[100.4°F\]), abdominal pain, uterine tenderness, or purulent drainage from the uterus.
Rates of Wound Infection
时间窗: Up to 6 weeks after delivery
Presence of either superficial or deep incisional surgical-site infection characterized by cellulitis or erythema and induration around the incision or purulent discharge from the incision site with or without fever and included necrotizing fasciitis. Wound hematoma, seroma, abscess or breakdown alone in the absence of the preceding signs did not constitute infection.
次要结局
- Rates of Maternal Fever(Up to 6 weeks after delivery)
- Rates of Serious Adverse Events(Up to 6 weeks after delivery)
- Rates of Maternal Postpartum Readmission or Unscheduled Visit(Up to 6 weeks after delivery)
- Rates of Postpartum Antibiotic Use(Up to 6 weeks after delivery)
研究者
Tali Wajsfeld
Principal Investigador
RWJ Barnabas Health at Jersey City Medical Center