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临床试验/NCT06239363
NCT06239363招募中不适用

Nutritional Sources of Salicylates and Disorders of Placental Angiogenesis in Preeclampsia

Poznan University of Life Sciences1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
angiogenesis biomarker: sFLT1

研究概览

简要总结

Preeclampsia (PE) is an important pregnancy complication and cause of maternal and perinatal mortality and morbidity. The underlying etiology and pathophysiology of preeclampsia is incompletely understood but it involves dysfunctional cytotrophoblastic invasion, placental ischemia, and release of inflammatory and endothelial mediators. Placenta dysfunction in PE is related to angiogenic balance. Currently, therapeutic options for the prevention and treatment of PE are limited. It is known that the risk of PE is reduced by low-dose aspirin. Therefore, the influence of salicylates on the development of PE seems to need to be investigated. This project plans to examine the preventive effects of food sources of salicylic acid and compare their effects with aspirin. Therefore, the aim of the present study is thus answer the following questions. whether the maternal dietary intake of salicylates is related to placental angiogenesis; 2. whether naturally occurring salicylates have the same effects on preeclampsia development and placental angiogenesis as aspirin. To answer these questions we plan to carry out a human study with pregnant women.

Due to the above the planned research aims to determine the association between maternal dietary intake of salicylates and placental angiogenesis and the risk of preeclampsia development.

Although PE remains an incurable disease, the results of this project will enable the development of dietary recommendations for the prevention and treatment of preeclampsia. Moreover, the results of this study may be useful in lowering the cost of maternal and fetal complications from preeclampsia and the cost of their hospitalization.

详细描述

Preeclampsia (PE) is one of the most important complications in pregnancy worldwide and is responsible for over 70,000 maternal deaths each year around the world. Babies born to women with PE often suffer from intrauterine growth restriction and preterm birth along with increased fetal pro-inflammatory profiles which require a long and costly hospitalization. PE results in placental dysfunction and it is now accepted that PE is a placental disease. Placenta dysfunction in PE is related to impaired angiogenic balance. Currently, therapeutic options for the prevention and treatment of PE are limited. It is known that the risk of PE is reduced by low-dose aspirin.

Therefore, the influence of salicylates on the development of PE seems to need to be investigated.

This project plans to examine the preventive effect of natural salicylates and compare their effects with aspirin. Therefore, the aim of the present study thus answer the following questions. whether the maternal dietary intake of natural salicylates is related to placental angiogenesis; 2. whether naturally occurring salicylates have the same effects on preeclampsia development and placental angiogenesis as aspirin.

The study will aim to determine the association between maternal dietary intake of salicylates and placental angiogenesis and the risk of preeclampsia development.

The study will be carried out in around 500 pregnant women (healthy and with PE) aged 18-45 years.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • age 18-45 years
  • healthy women with no previous adverse medical history and women with diagnosed preeclampsia
  • singleton pregnancy
  • people who have the full ability to give informed consent.

排除标准

  • pregnancies with detectable fetal defects, chromosomal abnormalities, genetic syndromes
  • infections
  • history of chronic hypertension, metabolic disorder before or during pregnancy, or the presence of high-risk factors such as heart diseases, diabetes, and renal diseases.

结局指标

主要结局

angiogenesis biomarker: sFLT1

时间窗: 3 years

measure in plasma and placenta

inflammatory biomarker: TNFα

时间窗: 3 years

measure in plasma

STOX-1 protein

时间窗: 3 years

measure in placenta

angiogenesis biomarker: PLGF

时间窗: 3 years

measure in plasma and placenta

daily intake using 24-hour Dietary Recall

时间窗: 3 years

evaluation of daily intake of nutrients (carbohydrate, fat, protein, vitamins, minerals, energy)

salicylates

时间窗: 3 years

measure in plasma and urine

inflammatory biomarker: hsCRP

时间窗: 3 years

measure in plasma

angiogenesis biomarker: VEGF

时间窗: 3 years

measure in plasma and placenta

次要结局

未报告次要终点

研究者

发起方
Poznan University of Life Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joanna Suliburska

professor

Poznan University of Life Sciences

研究点 (1)

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