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NCT Number: NCT06239363

Dietary Salicylates and Preeclampsia

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.

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Key information

Conditions

Pregnancy Disease Behavior Behavior, Animal Diet Habit Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Preeclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Poznan University of Life Sciences

Poznan, 60-624, Poland

Location status: Recruiting

Location contact

Joanna Suliburska, Professor

CONTACT

[email protected]

+48 618487260

About this study

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.

Daily food intake will be determined based on the FFQ questionnaire and dietary intake interviews. The amount of salicylic acid and total salicylates in the daily diet will be processed and evaluated.

Blood samples were collected from a maternal vein at the time of delivery. In plasma, it will be assayed salicylates, salicylic acid, TNFα, and hsCRP concentrations. Biomarkers of angiogenesis will be assayed in plasma: concentration of VEGF, PLGF, and sFLT1.

The placentas will be collected after delivery. Biomarkers of angiogenesis will be assayed in the placenta: concentration of VEGF, PLGF, and sFLT1. In the placenta, it will be measured mRNA and proteins of STOX 1. The vascularization process will be evaluated in the placenta.

Women will collect 24-hour urine. Salicylates and salicylic acid will be assayed in urine.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. daily intake using 24-hour Dietary Recall

    Time frame: 3 years

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

  2. salicylates

    Time frame: 3 years

    measure in plasma and urine

  3. angiogenesis biomarker: sFLT1

    Time frame: 3 years

    measure in plasma and placenta

  4. angiogenesis biomarker: VEGF

    Time frame: 3 years

    measure in plasma and placenta

  5. angiogenesis biomarker: PLGF

    Time frame: 3 years

    measure in plasma and placenta

  6. STOX-1 protein

    Time frame: 3 years

    measure in placenta

  7. inflammatory biomarker: TNFα

    Time frame: 3 years

    measure in plasma

  8. inflammatory biomarker: hsCRP

    Time frame: 3 years

    measure in plasma

Study contacts

Contact information is provided by the study sponsor or research team.

Joanna Suliburska, Professor

CONTACT

[email protected]

+48 61 8487260

Sponsors and collaborators

Lead sponsor

Poznan University of Life Sciences

Other

Registry information

Official study title

Nutritional Sources of Salicylates and Disorders of Placental Angiogenesis in Preeclampsia

Acronym: PreSal

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 2, 2024
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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