Prophylactic Antibiotics After Cesarean
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 321
- 试验地点
- 2
- 主要终点
- Surgical site infection
研究概览
简要总结
The purpose of this study is to determine if the addition of a 48-hour course of post-operative antibiotics to the recommended course of pre-operative antibiotics improves surgical site infection rate in patients who are obese and undergo Cesarean section after laboring.
详细描述
The investigators propose the conduction of a prospective, randomized, double-blinded clinical trial to evaluate an alternative prophylactic regimen for the prevention of surgical site infection in women who are obese and have been laboring prior to their Cesarean section. This study is to be conducted by the Department of Obstetrics & Gynecology at John Sealy Hospital at the University of Texas Medical Branch in Galveston, Texas. The intervention being studied will be the administration of cephalexin and metronidazole post-operatively for 48 hours. The primary outcome measure will be surgical site infection (including superficial or deep incisional surgical site infection, endometritis, and other related infections, such as septic pelvic thrombophlebitis and abdominal or pelvic abscess) in the post-operative period.
In order to most effectively and accurately analyze our primary and secondary research outcomes, the investigators will standardize our surgical operation techniques in all ways feasible. These recommendations will be in concordance with American College of Obstetrics and Gynecology recommendations, as those generally accepted in the medical literature. All patients will undergo surgery in the same small group of HEPA-filtered and positive air-pressure operating rooms. Appropriate limitations on number of surgeons and assistants scrubbed for surgery, as well as general OR traffic, will be enforced. Patients will undergo hair clipping of the incision site when appropriate. Chlorhexidine skin decontamination will be the standard surgical site preparation. An adhesive drape will be used. Prior to skin incision, cefazolin and azithromycin will be administered.
All patients to be considered for recruitment to this study will be undergoing delivery at John Sealy Hospital at the University of Texas Medical Branch in Galveston, Texas. Patients with an elevated BMI >or =30 kg/m2 who undergo cesarean section after laboring will be considered for randomization either prior to delivery or in the first 7 hours after delivery, to accommodate the need for the first dose of study medication or placebo 8 hours after surgery. Only patients who agree to inclusion after informed consent will be randomized per protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blinded
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women >18 and <50 years
- •BMI >30kg/m2
- •Decision by clinical team to perform Cesarean section
- •Rupture of membranes (ROM) < 24 hours after onset of labor or during the course of labor (ROM defined by spontaneous or artificial rupture of the amniotic sac)
排除标准
- •Subject unwilling or unable to provide consent
- •No prenatal care or a non-UTMB subject who is unlikely to be followed up after delivery
- •Fetal demise or major congenital anomaly
- •Immunosuppressed subjects: i.e., taking systemic immunosuppressants or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4<200, or other
- •Diagnosis or suspicion of chorioamnionitis prior to randomization
- •Other planned post-operative antibiotic administration
- •High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, bowel or adnexal surgery)
- •Known allergy or contraindication to cephalosporins or metronidazole
- •Incarcerated individuals
研究组 & 干预措施
Cephalexin and metronidazole
500 mg cephalexin per oral every 8 hours for a total of 6 doses; 500 mg metronidazole per oral every 8 hours for a total of 6 doses
干预措施: Cephalexin (Drug)
Cephalexin and metronidazole
500 mg cephalexin per oral every 8 hours for a total of 6 doses; 500 mg metronidazole per oral every 8 hours for a total of 6 doses
干预措施: Metronidazole (Drug)
Placebo / standard of care
Placebo pills per oral every 8 hours for a total of 6 doses
干预措施: Placebo (Drug)
结局指标
主要结局
Surgical site infection
时间窗: 6 weeks postpartum
Including superficial or deep incisional surgical site infection, endometritis, and other related infections, such as septic pelvic thrombophlebitis and abdominal or pelvic abscess
次要结局
- Maternal mortality(6 weeks (42 days) postpartum)
- Febrile morbidity(6 weeks (42 days) postpartum)
- Use of resources(6 weeks (42 days) postpartum)
- Postpartum antibiotic use(6 weeks (42 days) postpartum)
- Other adverse events(6 weeks postpartum)
- Wound hematoma or seroma(6 weeks (42 days) postpartum)