Does Preoperative Vaginal Preparation With Povidone-iodine Before Cesarean Delivery Reduce the Risk of Endometritis?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 668
- 试验地点
- 1
- 主要终点
- rate of postpartum endometritis
研究概览
简要总结
Cesarean delivery rates are increasing in Turkey and a major component of this increase is cesarean on demand. Although data on the rate of cesarean delivery in Turkey is limited, a national study reported a rate of 23.8%. Infectious morbidity, consisting primarily of endomyometritis and wound infection, remains a leading cause of postoperative complications. Estimates of postcesarean infection rates range from 7% to 20%, depending on demographic and obstetric variables. Infection following cesarean delivery results in not only increased hospital stay but also increases the cost of care. Strategies to minimize postoperative infectious and other morbidities have included modifications of surgical technique, changing of gloves, methods of placental delivery, cervical dilatation during cesarean delivery, and altering the uterine position during repair of the uterine incision. Despite these interventions, endometritis is still major problem after cesarean delivery.
Endometritis appears to result from ascending vaginal flora bacteria, with anaerobes playing an important role. The microbes endogenous to the vagina change throughout the course of pregnancy and parturition. Larsen and Galask noted that anaerobic species located in the vagina increase dramatically by the third postpartum day. In many cases, the surgeon's hand, reaching below the infant's head or presenting part, is in direct contact with the vagina. Vaginal bacterial flora have been cultured from the delivering surgeon's glove in 79% (95% confidence interval [CI] 58%, 100%) of cesareans that follow labor. In these cases, vaginal flora are delivered directly to the uterus, abdominal cavity, and the abdominal incision. Vaginal preparation has been shown to decrease the quantitative load of vaginal microorganisms as well as to remove certain species of bacteria.
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 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women older than 38 weeks estimated gestational age and required cesarean section.
排除标准
- •Highly emergent cesarean
- •Allergy to povidone iodine
- •Chorioamnionitis on admission
- •Fever on admission
研究组 & 干预措施
povidone iodine
30-second vaginal scrub with povidone- iodine solution.
干预措施: povidone- iodine solution. (Drug)
CONTROL
干预措施: placebo (Drug)
结局指标
主要结局
rate of postpartum endometritis
时间窗: 6 weeks
Endometritis was defined here as body temperature greater than 38.5C with concomitant foul-smelling discharge or abnormally tender uterus on bimanual examination
次要结局
- morbidity(two days)
研究者
Kemal GUNGORDUK
Mardin Women and Children Hospital
Erzincan Military Hospital
