NCT01903759终止不适用
Kinetics of Inflammation Markers in Maternal Plasma (Interleukins, Matrix Metalloproteinases -MMP): Study of the Correlation With the Diagnosis of Chorioamnionitis in Women Hospitalized for Spontaneous Rupture of the Fetal Membranes (SPROM) Before 34 Weeks of Amenorrhea (WA) With no Modification in the Usual Therapy.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- determination of plasma cytokines
研究概览
简要总结
The principal aim of this study is to help obstetricians to diagnose chorioamniotic infection early, in cases of premature rupture of the fetal membranes before 34 WA, by proposing earlier and more specific markers of infection than FBC and CRP. The aim is to reduce vital and functional risk of acute chorioamnionitis for the mother, the fetus or the newborn,.
If the kinetics profile of one or several markers correlates strongly with the diagnosis of chorioamnionitis, it could be used in clinical practice, possibly in the context of another clinical study.
The results of the study presented here are destined to be published in obstetrics journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Term between 24 and 34 WA
- •Spontaneous rupture of the fetal membranes
- •Singleton pregnancy
- •Age > 18 years
排除标准
- •Delivery within the hour following admission
- •Hospitalisation before 24 WA or after 34 WA
- •Hemorrhagic placenta previa or retroplacental hematoma, known auto-immune or inflammatory disease
- •Infection with human immunodeficiency virus (HIV)
- •Refusal to provide consent.
- •Patients provided for in articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code (e.g.: minors, adults under guardianship, etc...)
结局指标
主要结局
determination of plasma cytokines
时间窗: baseline
次要结局
未报告次要终点
研究者
研究点 (2)
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