Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery Receiving Two Differing Doses of Pre-operative Cefazolin.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Cefazolin Levels
研究概览
简要总结
Patients undergoing Cesarean delivery (C-Section) with a body mass index of 35 or greater (this BMI number is in the obese range) will be given either 2 grams or 4 grams of an antibiotic before surgery. The antibiotic is intended to prevent infection from the surgery.It is unknown what the best dose for large women is for the usual medicine used for this purpose (an antibiotic medicine called cefazolin).Samples of the tissue just under the skin will be biopsied at the time the incision is made and at the time the cut is stitched or stapled closed. A sample of the muscle of the womb will be taken as the womb is stitched closed after the delivery. Blood tests will be done at the start and end of surgery to test the antibiotic level. A blood sample will be taken from the umbilical cord after the baby has been delivered and the umbilical cord has been cut. The umbilical cord blood sample will be tested for the antibiotic level.These tests will be used to find out if the usual dose of medicine is enough or if more medicine is needed to prevent infection in large women undergoing c-sections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
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
- •Age 18 years or above
- •Body mass index (BMI) of 35 or greater at the time of the first obstetric clinic visit
- •Undergoing cesarean delivery
排除标准
- •BMI less than
- •Not undergoing Cesarean delivery.
- •Age less than 18 years.
- •Pre-existing infection.
- •Allergy to cephalosporin medications or a history of an anaphylactic reaction to penicillin.
- •Cesarean delivery being performed under emergent circumstances.
研究组 & 干预措施
2 gram dose of cefazolin
2 gram dose of pre-operative cefazolin
干预措施: cefazolin (Drug)
4 gram Dose
4 gram dose of pre-operative prophylaxis
干预措施: cefazolin (Drug)
结局指标
主要结局
Cefazolin Levels
时间窗: 2 hours
Cefazolin levels
次要结局
未报告次要终点
研究者
Michael Stitely
Adjunct Associate Professor
West Virginia University
