Search Elevated Serum Alkaline Phosphatase as a Marker of Prenatal Intervillositis Chronic Histiocytic (IHC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Number of subjects with alkaline phosphatase levels greater than or equal to 5 times the normal
研究概览
简要总结
Background : Chronic histiocytic intervillositis is a rare placental disease linked with poor perinatal outcome. In a recent study, a major antenatal increased alkaline phosphatase was suspected in patients affected by chronic histiocytic intervillositis. This increase may correspond to the release of alkaline phosphatase by the syncytiotrophoblaste prejudiced in this pathology.
Aim : To confirm the association between high levels of alkaline phosphatase and the occurrence of chronic histiocytic intervillositis.
详细描述
Single-center study of case-control comparing three groups of patients matched for gestational age at the time of sampling. The case group will be composed of patients who experienced chronic histiocytic intervillositis which an alkaline phosphatase assay is available during pregnancy (retrospective recruitment). Two control groups will be prospectively: The first will include patients whose pregnancy is low risk. The second will consist of pathological pregnancies (IUGR, Preeclampsia and Death In Utero). All patients will have a blood sample with determination of serum alkaline phosphatase activity and examination of the placenta at delivery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient aged 18 years or more
- •Having signed a free and informed consent
- •Enjoying a social security scheme
- •Inclusion criteria for cases:
- •Patient who gave birth at the Lille University Hospital between 2000 and
- •Lesion of intervillositis chronic histiocytic (IHC) diagnosed during histological examination of the placenta.
- •An alkaline phosphatase assay during pregnancy is available and has been achieved at University Hospital of Lille.
- •Prior information and not opposition of the patient to the secondary use of data collected in medical file.
- •Inclusion criteria for low-risk pregnancy :
- •No pathological obstetric history, no current pregnancy complications
- •Followed antenatal clinics at the Lille University Hospital
- •A gestational age corresponding to one of the cases (pairing ± 1 week)
- •No chronic intervillositis after pathological examination of the placenta
- •Inclusion criteria for high-risk pregnancy:
- •Patient hospitalized in the maternal-fetal pathology of the Lille University Hospital Service
- •Presence of IUGR, Death in Utero or severe preeclampsia with fetal repercussion
- •A gestational age corresponding to one of the cases (pairing ± 1 week)
- •No chronic intervillositis after pathological examination of the placenta
排除标准
- •Twin pregnancy
- •Liver disease in the interrogation
- •Lack of consent of the patient
- •Patient not covered by a social security scheme
- •Patient minor
- •Patient under guardianship
结局指标
主要结局
Number of subjects with alkaline phosphatase levels greater than or equal to 5 times the normal
时间窗: At the time of inclusion
次要结局
未报告次要终点