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临床试验/NCT06281366
NCT06281366招募中不适用

Diamine Oxidase and Adverse Pregnancy Outcomes

Hospital Universitari Vall d'Hebron Research Institute1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年2月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
75
试验地点
1
主要终点
Diamine oxidase activity first trimester

研究概览

简要总结

In normal pregnancies, blood histamine concentration remains within normal values; however, the serum histaminolytic activity is increased. Histamine is mainly produced by mast cells, platelets, basophils, neurons and enterochromatin cells, where it is stored and released when required. Reduced DAO activities have been found in high-risk pregnancies. Lower DAO activity has been associated to miscarriage, fetal demise, preeclampsia, low birthweight and preterm birth. The placenta is very rich in DAO activity and is the principal source of increased histaminolytic activity in normal pregnancies.

First-trimester screening for preeclampsia (PE) is a routine screening which is performed in the first trimester. Women with a positive result are at a greater risk of PE but also other pregnancy complications such as stillbirth, preterm birth and low birthweight. These cases are prescribed aspirin until term. This intervention has demonstrated to significantly reduce the risk of PE and other complications. Unfortunately, aspirin does not avoid all cases with adverse outcomes, indicating that additional mechanisms may be involved in the development of such pregnancy complications, such as DAO decreased activity.

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

入选标准

  • Single pregnancy
  • Maternal age ≥18
  • High risk (≥1/50) in the first-trimester screening for preeclampsia
  • Gestational age between 11+0 and 16+6 weeks of gestation

排除标准

  • Fetal malformation
  • Fetal death
  • Maternal digestive inflammatory disease or intolerance
  • Refusal to give informed consent

结局指标

主要结局

Diamine oxidase activity first trimester

时间窗: 11-16+6 weeks of gestation

diamine oxidase enzime activity in maternal blood

Diamine oxidase gene polymorphisms

时间窗: 11-16+6 weeks of gestation

variants of the AOC1 gene: rs10156191, rs1049742, rs1049793 and rs2052129

次要结局

  • Placental histamine levels at delivery(At the time of delivery)
  • Blood histamine levels at delivery(At the time of delivery)
  • Placental Diamine oxidase activity at delivery(At the time of delivery)
  • Urine histamine levels at delivery(At the time of delivery)
  • Blood Diamine oxidase activity at delivery(At the time of delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Diamine Oxidase and Adverse Pregnancy Outcomes | 临床试验