Nutritional Sources of Salicylates and Disorders of Placental Angiogenesis in Preeclampsia
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
- 是
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
Joanna Suliburska
professor
Poznan University of Life Sciences
