Chlorhexidine Gluconate vs Povidone-Iodine Vaginal Cleansing Solution Prior to Cesarean Delivery: A Randomized Comparator Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,114
- 试验地点
- 2
- 主要终点
- Postoperative wound infection
研究概览
简要总结
Endometritis, an infection of the uterus in the postpartum period, has been shown to complicate the postoperative course of a cesarean delivery in 6% to 27% of cases. Vaginal cleansing prior to cesarean delivery has been shown to minimize the presence of micro-organisms and risk of infection. Although povidone-iodine is the most commonly used anti-septic for surgical preparation of the vagina, it is not an ideal agent due to it's diminished efficacy in acidic vaginal pH and in the presence of blood. Chlorhexidine gluconate, on the other hand, has demonstrated superior disinfectant properties in several clinical trials, as compared to povidone iodine. In this randomized, comparator controlled, study the investigators will be comparing chlorhexidine gluconate vs povidone iodine for intrapartum vaginal preparation in women undergoing non-emergent cesarean delivery.
详细描述
This is a randomized, comparator controlled, study of intrapartum vaginal preparation with either chlorhexidine gluconate or povidone-iodine solution. Women undergoing non-emergent cesarean delivery will be randomized to receive vaginal cleansing with either 4% chlorhexidine solution or 10% providone-iodine solution.
The study will have two arms that will be randomized in a 1:1 ratio. After inclusion criteria have been satisfied, subjects in the comparator control arm will receive vaginal preparation with 10% provodone-iodine solution prior the skin incision. Subjects in the study arm will receive vaginal preparation with chlorohexidine gluconate 4% solution. The selected skin preparation will be applied according to the manufacture guidelines with a minimum of four completed minutes of drying time before placement of surgical drapes. A block randomization method will be used to control for variations in care. Both groups will receive standard obstetrical care, continuous fetal monitoring, and pre-operative prophylactic antibiotics at least one hour prior to skin incision.
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
- 是
入选标准
- •Patients at Richmond University Medical Center that have a non-emergent cesarean delivery
排除标准
- •Emergent cesarean delivery, less than 18 years of age, chorioamnionitis before randomization, intrapartum fever prior to randomization, or known or suspected allergy to chlorhexidine or iodine.
研究组 & 干预措施
Chlorhexidine gluconate
4% chlorhexidine gluconate solution will be used for vaginal cleansing prior to non-emergent cesarean section. The preparation will be applied according to manufacture guidelines. The group will receive standard obstetrical care, continuous fetal monitoring, and pre-operative prophylactic antibiotics at least one hour prior to skin incision.
干预措施: Chlorhexidine gluconate (Procedure)
Povidone Iodine
10% povidone iodine solution will be used for vaginal cleansing prior to non-emergent cesarean section. The preparation will be applied according to the manufacture guidelines with a minimum of four completed minutes of drying time before placement of surgical drapes. The group will receive standard obstetrical care, continuous fetal monitoring, and pre-operative prophylactic antibiotics at least one hour prior to skin incision.
干预措施: Povidone Iodine (Procedure)
结局指标
主要结局
Postoperative wound infection
时间窗: 0-14 days postpartum
Erythema surrounding the incision site or pus-like incisional drainage in the presence or absence of fever
次要结局
- Postpartum endometritis(0-14 days post-partum)
- Postoperative fever(0-14 days post-partum)
- Side effects(0-14 days post-partum)
研究者
Nisha Lakhi, MD
Director of Research
Richmond University Medical Center