A Randomized Clinical Trial of Cefazolin Versus Cefazolin Plus Azithromycin Prophylaxis in Post-Cesarean Endometritis
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Development of post cesarean endometritis
研究概览
简要总结
Despite the generalized use of preoperative antibiotic prophylaxis, endometritis remains as the most frequent post-cesarean delivery complication. This increased morbidity translates into extended post-partum antibiotic use and prolongation of hospital stay with the subsequent increase in health care expenses. The current regimen recommended by the American College of Obstetricians and Gynecologists for cesarean delivery prophylaxis (1st generation cephalosporins) does not cover for Ureaplasma Urealyticum, a microorganism that has been associated with an increased risk of endometritis in post-cesarean section patients. Azithromycin, an antibiotic that has both aerobic and some anaerobic coverage, uniquely covers Ureaplasma and would be an excellent second antibiotic for cesarean section chemoprophylaxis. Our hypothesis is that the addition of azithromycin to standard chemoprophylaxis with cefazolin can effect a 25% reduction of post-cesarean section endometritis.
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
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant patients between 37 and 42 weeks gestational weeks.
- •Pregnant patients undergoing indicated cesarean section at Truman Medical Center Hospital July 2012 and July
- •Pregnant patient that received prenatal care at Truman Medical Center. Hospital Hill, Samuel Rogers or Swope Parkway health centers at least 1 month prior to the Cesarean delivery.
- •Signed informed consent.
排除标准
- •Allergy to cephalosporins or azithromycin.
- •Refusal to sign consent form.
- •Clinical signs of chorioamnionitis: fever 100.4 F or higher, uterine tenderness, maternal or fetal tachycardia.
- •Immunocompromised condition: HIV positive with CD4 count below 200, chronic steroid use, pregestational diabetes, cancer, chemotherapy.
- •Need for emergent cesarean precluding consent or availability of study medication.
- •Need for hysterectomy at cesarean section.
- •Use of antibiotic in the 72 hours prior to admission.
研究组 & 干预措施
Cefazolin + Azitrhromycin
double antibiotic
干预措施: Cefazolin (Drug)
Cefazolin
single antibiotic
干预措施: Cefazolin (Drug)
Cefazolin + Azitrhromycin
double antibiotic
干预措施: Azithromycin (Drug)
结局指标
主要结局
Development of post cesarean endometritis
时间窗: 3-4 days while in hospital during post partum period
次要结局
- Hospital stay length(3-4 days while in hospital during post partum period)
研究者
Pedro Morales-Ramirez
MD
University of Missouri, Kansas City