Pregnancy DiseasePreSalNCT06239363
Dietary Salicylates and Preeclampsia
An observational study of Pregnancy Disease and Preeclampsia, run by Poznan University of Life Sciences at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Disease, Preeclampsia, Diet Habit
- How many people
- 500 participants
- Where
- 1 sitePoland
- Study dates
- 8 Jan 2024to 30 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study will be carried out in around 500 pregnant women (healthy and with preeclampsia) aged 18-45 years.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Life Sciences
Poznan, 60-624
Joanna Suliburska, Professor, +48 618487260, joanna.suliburska@up.poznan.pl
About this study
Official title: Nutritional Sources of Salicylates and Disorders of Placental Angiogenesis in 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.
Read the detailed description
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.
- Conditions
- Pregnancy Disease, Preeclampsia, Diet Habit
- Keywords
- pregnancy, preeclampsia, angiogenesis, salicylates
- Medical subject headings
- Pre-Eclampsia, Feeding Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
daily intake using 24-hour Dietary Recall
evaluation of daily intake of nutrients (carbohydrate, fat, protein, vitamins, minerals, energy)
Measured: 3 years
salicylates
measure in plasma and urine
Measured: 3 years
angiogenesis biomarker: sFLT1
measure in plasma and placenta
Measured: 3 years
angiogenesis biomarker: VEGF
measure in plasma and placenta
Measured: 3 years
angiogenesis biomarker: PLGF
measure in plasma and placenta
Measured: 3 years
STOX-1 protein
measure in placenta
Measured: 3 years
inflammatory biomarker: TNFα
measure in plasma
Measured: 3 years
inflammatory biomarker: hsCRP
measure in plasma
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start8 Jan 2024
- Primary completion28 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Suliburska, Poznan University of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239363
- Sponsor's protocol ID
- 34/2023
- Acronym
- PreSal
- Status last verified
- Mar 2026
- First submitted
- 23 Jan 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Sources of Salicylates and Disorders of Placental Angiogenesis in Preeclampsia
- ClinicalTrials.gov ID
- NCT06239363
- Acronym / sponsor ID
- PreSal / 34/2023
- Conditions
- Pregnancy Disease, Preeclampsia, Diet Habit
- Keywords
- pregnancy, preeclampsia, angiogenesis, salicylates
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Poznan University of Life SciencesUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 28 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will be carried out in around 500 pregnant women (healthy and with preeclampsia) aged 18-45 years.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
daily intake using 24-hour Dietary Recall
Time frame: 3 years
evaluation of daily intake of nutrients (carbohydrate, fat, protein, vitamins, minerals, energy)
salicylates
Time frame: 3 years
measure in plasma and urine
angiogenesis biomarker: sFLT1
Time frame: 3 years
measure in plasma and placenta
angiogenesis biomarker: VEGF
Time frame: 3 years
measure in plasma and placenta
angiogenesis biomarker: PLGF
Time frame: 3 years
measure in plasma and placenta
STOX-1 protein
Time frame: 3 years
measure in placenta
inflammatory biomarker: TNFα
Time frame: 3 years
measure in plasma
inflammatory biomarker: hsCRP
Time frame: 3 years
measure in plasma
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Disease and Preeclampsia, run by Poznan University of Life Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joanna Suliburska, Professor (+48 61 8487260, joanna.suliburska@up.poznan.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
daily intake using 24-hour Dietary Recall (time frame: 3 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.