NCT05021315Unknown3 期
Effect of Vaginal Cleaning Using Povidone Iodine Before CS to Reduce Postoperative Wound Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Postoperative wound complication
研究概览
简要总结
The aim of work to assess the effectiveness of preoperative vaginal cleansing with povidone iodine on reduction of post caesarean section wound infection
Research questions:
Does vaginal cleaning using povidone iodine before cesarean section has effect on reduction of postoperative wound infection??
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 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women who are 37 weeks gestation or more scheduled for elective cesarean section or those in labor with a limited number of vaginal examinations less than 5 times preoperatively.
- •Pregnant women who are 37 weeks gestation or more with rupture of membranes but duration less than 24 hours
- •Women consenting to be included in the study.
- •Exclusion criteria:
- •Abnormally invasive placenta and placenta previa.
- •Intra-partum fever.
- •Prolonged rupture of membranes more than 24 hours
- •History of exposure to radiation treatment for cancer.
- •History of Gynecological infections (PID).
- •History of abdominal infections, e.g., peritonitis.
- •Debilitating diseases like Diabetes mellitus, Thyroid disorders, Cushing disease, abdominal malignancy.
- •Obesity is defined as pregnant BMI >30 kg/m
- •History of wound infection or burst abdomen.
- •History suggestive of massive bleeding during previous cesarean section.
- •allergy to iodine-containing solutions
- •Pregnant women with severe anemia defined as Hb <7 g/dl.
- •Cases with intra-abdominal drain deployment are discarded.
- •Obstructed labor with numerous vaginal examinations.
排除标准
- 未提供
研究组 & 干预措施
Iodine group
Experimental
50 women who received preoperative vaginal cleansing with 10% povidone-iodine.
干预措施: 10% povidone iodine (Drug)
结局指标
主要结局
Postoperative wound complication
时间窗: 1 week
Any sign of infection as redness, hotness and tenderness as well as pyrexia occurance in wound postoperative
次要结局
未报告次要终点
研究者
ahmed nagy shaker ramadan
Principal investigator
Cairo University
研究点 (2)
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