NCT04163679终止不适用
Combining Vaginal Preparation and Azithromycin in Reduction of Post Cesarean Infections: A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Infection rates
研究概览
简要总结
asdgf
详细描述
asdf
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 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •full term pregnancy
- •undergoing labored, non-emergent cesarean section
- •patient in labor
排除标准
- •Azithromycin contraindicated:
- •Known hypersensitivity to azithromycin, erythromycin, macrolides or ketolide medications.
- •liver dysfunction
- •Prescription medications which may interact with azithromycin, such as nelfinavir or warfarin
- •A history of a cardiac dysrhythmia (irregular heartbeats)
- •Known hypersensitivity to iodine
- •Patients carrying fetuses with known congenital anomalies
- •Immunodeficiency
- •Patients who are not in labor at the time of delivery
- •Non-english speaking subjects or subjects with language barriers
研究组 & 干预措施
Vaginal Preparation
Experimental
In addition to standard care, subjects will undergo vaginal preparation (VP). A VP kit includes sponge sticks and sponges soaked in a povidone-iodine 10% solution.
干预措施: Vaginal Preparation (Procedure)
Standard Infection Procedures
Sham Comparator
The very staff will follow hospital protocols for the cesarean delivery. The subject and the infant will be provided care in accordance with current medical standards and be discharged at the discretion of the attending physician.
干预措施: Vaginal Preparation (Procedure)
结局指标
主要结局
Infection rates
时间窗: six weeks postpartum
endometritis
Infection rates
时间窗: Six weeks postpartum
wound infection
次要结局
- Infant Birth Weight(Four weeks after birth)
- Infant Apgar scores(Four weeks after birth)
- Infant Length of hospital stay(Four weeks after birth)
- Numbers of Infants admitted to NICU(four weeks after birth)
- Number of Infants that develop respiratory distress(Four weeks after birth)
- Number of Infants that develop sepsis(Four weeks after birth)
- Number of infants that die(Four weeks after birth)
研究者
Karen L Wilson
Program Director of Obstetrics and Gynecology Residency Chief of Maternal Fetal Medicine and Obstetrics Chief
Womack Army Medical Center
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Fosmidomycin and Azithromycin for Acute Uncomplicated Plasmodium Falciparum Malaria (P. Malaria) in AdultsMalariaNCT01464125Jomaa Pharma GmbH43
已完成
3 期
Benefits of systemically administered adjunctive azithromycin with non-surgical periodontal therapy in treating advanced gum disease.Stage III and IV, grade C periodontitisOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonACTRN12619000560190School of Dentistry, University of Queensland56
已完成
2 期
Azithromycin Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in BangladeshUncomplicated Falciparum MalariaNCT00356005Medical University of Vienna228
尚未招募
1 期
Azithromycin with full mouth cleaning in pyorrhoea patientsCTRI/2020/10/028692Sharad Pawar Dental College Hospital
已完成
不适用
Efficacy of Azithromycin as an Adjunct to Non-Surgical Periodontal TreatmentPeriodontitisNCT03629288Universidad Nacional Andres Bello18