Vitamin C for the Prevention of Catheter-associated Urinary Tract Infections in Women Who Undergo Elective Gynecological Surgeries: a Study Protocol for a Randomized Double Blinded Controlled Trial.
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Proportion of participants who experienced clinically diagnosed and treated UTI.
研究概览
简要总结
This open-label randomized trial aims at assessing the role of Vitamin C pills in the prevention of catheter-associated urinary tract infections in women undergoing elective gynecological surgeries.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Vitamin C and Placebo pills will be blindly labeled and assorted in opaque containers in the Pharmacy department according to a computer generated list that allocated random assignment of vitamin C or placebo to a 200 positions (serial numbers from 1 to 200).
The research assistant in charge of the recuitment will not be aware of the content of each opaque container and would be providing them to patients according to the order in which they are recruited starting with container number 1, then 2 and so on.
The primary care provider and the investigators are blinded as well as they are not aware of the assignment of each recruited patient to placebo vs interventional arm.
It is only upon completion of data collection that results would be compared with the randomized generated list in order to link the recruited patients and their collected data with their original assignment to placebo vs intervention.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non pregnant women at least 18 years of age visiting the Preadmission unit (PAU) or the OBGYN floor (7N), presenting for elective GYN surgery at the American University of Beirut Medical Center (AUBMC).
排除标准
- •Any women with the following:
- •Nephrolithiasis
- •Congenital anomaly or neurogenic bladder
- •Allergy to ascorbic acid
- •Who require therapeutic anticoagulant medicine during the 6 weeks after surgery
- •Surgery did involve a fistula repair or a vaginal mesh removal
- •Positive Urinalysis in the PAU
- •Recurrent UTI's
- •Hemochromatosis
- •Renal disorders
- •Patients already taking Vitamin C supplementation will also be excluded from the study.
研究组 & 干预措施
Women on a vitamin C regimen
Women who are undergoing elective gynecological surgeries and who are randomized to take 1g of vitamin C for 14 days.
干预措施: Ascorbic Acid 1000 mg (Drug)
Women on a placebo regimen
Women who are undergoing elective gynecological surgeries and who are randomized to take placebo for 14 days
干预措施: Placebo (Other)
结局指标
主要结局
Proportion of participants who experienced clinically diagnosed and treated UTI.
时间窗: 14 days
Urinary tract infection is diagnosed by a positive urine culture.
次要结局
- Proportion of participants with asymptomatic bacteruria(14 days)
研究者
Tony Bazi
Associate Professor of Clinical Obstetrics and Gynecology
American University of Beirut Medical Center