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临床试验/NCT04699825
NCT04699825Unknown不适用

Cardiovascular Changes in the Infants of Mothers With Preeclampsia and Factors Associated With Neonatal Outcomes

Assiut University0 个研究点目标入组 20 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
主要终点
Cardiac changes

研究概览

简要总结

Preeclampsia (hypertension during pregnancy) is a common problem affecting 2-8% of pregnancies worldwide and is typically diagnosed by increased blood pressure and proteinuria. The rate of preeclampsia has increased since the 1980s with higher rates at extreme maternal ages as well as during the first pregnancy. Pre-eclampsia is a serious hypertensive disorder of pregnancy affecting outcomes for both mother and infants. These infants not only have increased risk of neonatal complications including preterm birth, intrauterine growth restriction, abnormal Doppler parameters, feed intolerance, intestinal problem, poor growth, and long term lung condition but also have increased risk of cerebral palsy, abnormal neurodevelopmental outcomes, cardiovascular disease, stroke, and mental disorders during childhood and adulthood.

详细描述

Preeclampsia is diagnosed according to the International Society for the Study of Hypertension in Pregnancy (ISSHP) criteria: BP > 140/90 on two occasions in previous normotensive mother after 20 weeks of gestation and one of the following; proteinuria in urine > 0.3 gram/kg/day or acute kidney or liver dysfunction or signs of uterine dysfunction. The onset of preeclampsia can be early before 34 weeks of pregnancy (Early-onset preeclampsia) or late after 34 weeks of pregnancy (Late-onset preeclampsia). Early-onset preeclampsia, especially between 28-32 weeks gestation, is characterized by a high prevalence of microvascular changes in the placenta that makes mothers and their infants are more liable to complication. The pathogenesis of preeclampsia is unclear.

Preeclampsia affects hematopoiesis and the fetal myeloid lineage leading to thrombocytopenia, neutropenia, decrease phagocytic function, decrease T regulatory cells, and an increase in cytotoxic natural killer cells in neonates. Innate and adaptive immunity are regulated by myeloid cells and the immune changes in infants of preeclampsia mothers could lead to increased incidence of neonatal sepsis and the development of chronic inflammatory conditions.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
1 Minute 至 3 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Infants born from Pregnant women with preeclampsia, their mother willing to give consent.

排除标准

  • 1-Infant with a major heart problem.
  • Infants with major congenital and genetic anomalies.

结局指标

主要结局

Cardiac changes

时间窗: within 72 hours after birth

cardiac output will be presented by ml/minute

Vascular changes in superior mesenteric and anterior cerebral arteries

时间窗: 72 hours after birth

Doppler parameters( peak-systolic velocity, end-diastolic velocity, and mean velocity. All will be measured in meter/second

Cardiac function changes

时间窗: within 72 hours after birth

Fractional shortening and ejection fraction will be presented by percentage

次要结局

  • Feeding problem(3 months after birth)
  • oval all outcomes(3 months)
  • immunological changes(cord blood at birth)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ASAli

Assistant lecturer

Assiut University

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