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临床试验/NCT01538134
NCT01538134Unknown不适用

Antiphospholipid Antibodies and Early Fetal Growth Restriction (<34 Weeks of Gestation). A Case Control Study.

Saint Thomas Hospital, Panama1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
1
主要终点
Lupus anticoagulant

研究概览

简要总结

The Antiphospholipid Syndrome is an immune disease where the presence of antibodies directed against cell membrane phospholipids (antiphospholipid antibodies) can cause an hypercoagulable state that causes thrombosis and obstetric complications (miscarriages, stillbirths). Since 1999 the Sapporo Criteria for Antiphospholipid Syndrome diagnosis includes the development of fetal growth restriction (diagnosed postpartum), but this was done without solid evidence of a relation between the two or using the most common form of fetal growth restriction diagnosis (ultrasound). Our study will try to add information to this particular point.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Gestational age between 24-34 weeks.
  • Ultrasonographic evidence of fetal growth restriction
  • Abdominal circumference < 3rd percentile.
  • Doppler with increase of placental resistance.

排除标准

  • Known antiphospholipid syndrome.
  • Known presence of antiphospholipid antibodies.
  • Patients with systemic lupus erythematosus.

结局指标

主要结局

Lupus anticoagulant

时间窗: 8 months

Number of cases positive for Lupus Anticoagulant.

Anticardiolipin antibodies

时间窗: 10 months

Number of cases with high/medium levels of IgG/IgM of anticardiolipin antibodies.

B2 Glycoprotein I

时间窗: 10 months

Number of cases with levels of B2 Glycoprotein I \> 99%

次要结局

未报告次要终点

研究者

发起方
Saint Thomas Hospital, Panama
申办方类型
Other
责任方
Principal Investigator
主要研究者

Osvaldo A. Reyes T.

Coordinator of Research & Development

Saint Thomas Hospital, Panama

研究点 (1)

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