跳至主要内容
临床试验/NCT00386477
NCT00386477终止不适用

Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial

Indiana University School of Medicine6 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2006年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
300
试验地点
6
主要终点
Number of Participants Who Experienced Composite Endometritis Plus Wound Complications.

研究概览

简要总结

The objective of the project is to find out whether cleansing the vagina before a cesarean delivery decreases the risk of complications and infections after having the baby. If this is the case, cleansing the vagina before cesarean delivery can help improve outcomes for many women and make their early postpartum recovery much more pleasant, giving a healthier start for the family.

详细描述

Infectious morbidity frequently complicates cesarean delivery. Endometritis can complicate the postoperative course of a cesarean delivery 6-27% of the time. This complication, up to 10 times more frequent than after vaginal delivery, can lead to serious complications. Additionally, cesarean deliveries are frequently complicated by maternal fever and wound complications including seroma, hematoma, infection, and separation. These morbidities can lead to significant delay in a return to normal function. Our study will randomize 1000 women who are about to undergo a cesarean delivery into one of two groups. The control group will receive the standard surgical preparation of the abdomen alone, the current standard pre-cesarean preparation. The other group will also receive a povidone iodine washing/scrub of the vagina before the cesarean delivery. Maternal and surgical variables will be recorded. At one months postpartum, maternal outpatient data will be reviewed and the incidence of postpartum uterine infection, wound separations, and other wound and infectious complications will be determined and compared between the two treatment groups.

Comparison: Women receiving standard surgical abdominal cleansing versus women receiving standard abdominal and preoperative vaginal cleansing before cesarean delivery.

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
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

入选标准

  • Woman undergoing cesarean delivery
  • At least 18 years of age

排除标准

  • Allergy to iodine containing solutions
  • Planned cesarean hysterectomy

结局指标

主要结局

Number of Participants Who Experienced Composite Endometritis Plus Wound Complications.

时间窗: 1 month

Endometritis was diagnosed clinically as uterine pain and fever requireing antibiotics. Wound complications included wound infection, seroma, hematoma, or separation.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (6)

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