Dietary Salicylates and Preeclampsia

NCT06239363 | Recruiting

• 1 other identifier: 34/2023
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preeclampsia; Diet Habit; Pregnancy Disease

Keywords

pregnancy; preeclampsia; angiogenesis; salicylates

Outcome Measures

Primary Outcomes (8)

• daily intake using 24-hour Dietary Recall

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

  3 years

• salicylates

  measure in plasma and urine

  3 years

• angiogenesis biomarker: sFLT1

  measure in plasma and placenta

  3 years

• angiogenesis biomarker: VEGF

  measure in plasma and placenta

  3 years

• angiogenesis biomarker: PLGF

  measure in plasma and placenta

  3 years

• STOX-1 protein

  measure in placenta

  3 years

• inflammatory biomarker: TNFα

  measure in plasma

  3 years

• inflammatory biomarker: hsCRP

  measure in plasma

  3 years

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poznan University of Life Sciences: lead

Study Sites (1)

Poznan University of Life Sciences

Poznan, 60-624, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine, placenta

MeSH Terms

Conditions

Pre-Eclampsia; Feeding Behavior

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior, Animal; Behavior

Central Study Contacts

Joanna Suliburska, Professor

CONTACT

+48 61 8487260; joanna.suliburska@up.poznan.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 2, 2024
• Study Start: January 8, 2024
• Primary Completion (Estimated): September 28, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

PL (1)