Preoperative Vaginal Cleansing With Povidone Iodine and the Risk of Post Cesarean Endometritis
试验速览
- 阶段
- 4 期
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- Number of Subjects with post cesarean endometritis
研究概览
简要总结
Preoperative vaginal cleansing with povidone iodine and the risk of post cesarean endometritis.
详细描述
Study Population:
Women undergoing cesarean sections will be enrolled in this study after obtaining verbal consent as there are no extra interventional measures that will be undertaken in the study apart from routine investigations and procedures done during cesarean sections, being already approved in signed consent to undergo treatment.
The nature and aim of the work will be fully discussed to all women who will agree to participate in the study. Verbal consent will be obtained from all patients enrolled in the study which is approved by the local ethical committee.
Preoperative evaluation of patients included:
- Medical history taking including:
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
- •Patients 18-40 years of age who will undergo cesarean deliveries.
- •Able to communicate well with the investigator & to comply with the requirements of the entire study.
- •Verbal consent obtained from subject and husband / witness before undergoing the study entry (with the understanding that consent may be withdrawn by the patient at any time without prejudice).
排除标准
- •Patients with allergy to iodine containing solutions.
- •Patients with ante-partum hemorrhage.
- •Patients with ruptured membranes.
- •Patients with any known disease that increases the risk of infection e.g. immunocompromized, those receiving steroids ...etc.
研究组 & 干预措施
povidone iodine
153 cases undergoing cesarean sections will have preoperative vaginal cleansing with 10% povidone iodine
干预措施: 10% povidone iodine (Drug)
结局指标
主要结局
Number of Subjects with post cesarean endometritis
时间窗: 48 hours
Number of Subjects with post cesarean endometritis as diagnosed by fever 38.4°C and greater in first 48 hours after cesarean section with any of the following (uterine tenderness, foul smelling lochia or positive C-reactive protein)
次要结局
- Number of Subjects with allergic reaction to povidone iodine(48 hours)
研究者
Amr Ahmed Mahmoud Riad
Lecturer of obstetrics and gynecology
Ain Shams Maternity Hospital