Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation
试验速览
- 阶段
- 4 期
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Change of pelvic infection after surg ical evacuation of miscarriage with use of antibiotic prophylaxis.
研究概览
简要总结
To determine the role of antibiotic prophylaxis in the surgical management of miscarriage.
详细描述
Patients will be randomized to receive either prophylactic antibiotic [a single dose of oral doxycycline (200 mg) and metronidazole (500 mg)] or placebo using identical sealed envelopes.Included cases are those with early miscarriage (within the first trimester 12 6/7 weeks of gestation) , missed or incomplete miscarriage, undergoing surgical management will be included in the study.
Technique:
The investigators will prepare 138 identical envelops, half of them filled with a label group(1) who are the group to receive the antibiotic prophylaxis with all instruction details, while the other half filled with a label identifying ( group 2) who are the placebo group. All envelops will be prepared by the investigator and sealed before starting enrollment. After enrollment, each participant will be allowed to choose one envelop to determine to which group the patient will be assigned to.
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 (Participant)
盲法说明
138 identical envelops, half of them filled with a label(Group 1) who are the "Prophylactic antibiotic" group with all instruction details, while the other half are labelled (group 2) who are the "Placebo" group with all instruction details. All envelops will be prepared by the investigator and sealed before starting enrollment. After enrollment, each participant will be allowed to choose one envelop to determine to which group she will be assigned.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change of pelvic infection after surg ical evacuation of miscarriage with use of antibiotic prophylaxis.
时间窗: 2 weeks from surgery
White cell count \>12 \*10\^9 cells / L by CBC
次要结局
- Change in the risk of severe puerperal sepsis following the surgical procedure(2 weeks from surgery)
研究者
Marwa Mohamed Mahmoud Eid
Principal investigator
Cairo University