The Effect of Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline on Vaginal Bacteria Colony Counts in Pregnant Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Post-intervention Aerobic Bacterial Colony Counts
研究概览
简要总结
The purpose of this study is to see whether chlorhexidine is superior to povidine-iodine vaginal antisepsis at reducing bacteria colony counts in pregnant women by comparing three groups: vaginal washing with chlorhexidine-alcohol, vaginal washing with povidine-iodine, and vaginal washing with saline alone.
详细描述
This is a prospective trial of vaginal preparation (or vaginal cleansing/washing) on late preterm and term pregnancies admitted to Labor & Delivery unit for cesarean delivery with three arms. Randomization allocation would be performed in 1:1:1 fashion for vaginal preparation with chlorhexidine-alcohol, povidine-iodine, and saline washes. A saline wash group is included to determine if the act of cleansing the vagina with a sponge alone reduces bacterial colony counts.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women admitted for cesarean delivery
- •Gestational age greater than or equal to 34 weeks
排除标准
- •Rupture of membranes or active labor
- •Chorioamnionitis (prior to enrollment)
- •Recent (within 4 weeks) antibiotic exposure
- •Maternal HIV infection or immunocompromised state
- •Known allergy to shellfish, iodine, or chlorhexidine
研究组 & 干预措施
Chlorhexidine-alcohol
Subjects will receive vaginal preparation with chlorhexidine-alcohol.
干预措施: Chlorhexidine-alcohol (Drug)
Povidine-iodine
Subjects will receive vaginal preparation with povidine-iodine.
干预措施: Povidine-iodine (Drug)
Saline
Subjects will receive vaginal preparation with sterile saline.
干预措施: Sterile saline (Drug)
结局指标
主要结局
Post-intervention Aerobic Bacterial Colony Counts
时间窗: From intervention to 7 days post
Vaginal cultures are collected after the vaginal preparation intervention. These undergo serial dilutions and are incubated on Tryptic Soy Agar for seven days. Bacteria colony counts were determined by blinded investigators on day 7.
Post-intervention Anaerobic Bacterial Colony Counts
时间窗: From intervention to 7 days post
Vaginal cultures are collected after the vaginal preparation intervention. These undergo serial dilutions and are incubated on Tryptic Soy Agar for seven days. Bacteria colony counts were determined by blinded investigators on day 7.
次要结局
- Baseline Anaerobic Bacterial Colony Counts(From intervention to 7 days post)
- Baseline Aerobic Bacterial Colony Counts(From intervention to 7 days post)
研究者
Yiping Weng Han
Professor of Microbial Sciences
Columbia University