NCT05971654尚未招募2 期
Effect Of Azithromycin On Pregnancy Prolongation In Women at Risk of Preterm Labour
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Gestational age at time of delivery
研究概览
简要总结
The aim of this study is to evaluate the benefit of the addition of azithromycin to standard treatments to prolong pregnancy in women having intact membranes and is at risk of or in preterm labour.
详细描述
Study Design:
Comparative controlled study.
Study site :
The study will be conducted at the department of Obstetrics and Gynecology at Beni-Suef University Hospital.
Study period:
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
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •24 < Pregnancy <37 weeks of gestation.
- •Threat or history of preterm labour.
- •Preterm labour itself (Non established)
排除标准
- •antibiotics use within 14 days (except for pericerclage prophylaxis, or streptococcus B prophylaxis);
- •PPROM; and fetal extraction required <37 weeks.
- •Current or past history of medical diseases (Diabetes Milletus, Hypertension, Systemic Lupus Erythematosus, Cardiac diseases, etc ).
- •Adverse perinatal outcome due to abdominal trauma.
- •Structural fetal anomalies detected during anomaly scan.
- •Allergy to Azithromycin.
研究组 & 干预措施
Azithromycin
Experimental
azithromycin.:500 mg PO once for 5 days every month
干预措施: azithromycin (Drug)
结局指标
主要结局
Gestational age at time of delivery
时间窗: 9 months
measured in week's days'number
次要结局
未报告次要终点
研究者
Sara Abdallah Mohamed Salem
Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Beni-Suef University
研究点 (1)
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