Dietary Salicylates and Preeclampsia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorPoznan University of Life Sciences

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

daily intake using 24-hour Dietary Recall

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

Time frame
3 years
2

salicylates

measure in plasma and urine

Time frame
3 years
3

angiogenesis biomarker: sFLT1

measure in plasma and placenta

Time frame
3 years
4

angiogenesis biomarker: VEGF

measure in plasma and placenta

Time frame
3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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