| NCT ID | NCT06239363 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Poznan University of Life Sciences |
| Condition | Pregnancy Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-01-08 |
| Primary Completion | 2027-09-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2024-01-08 with a primary completion date of 2027-09-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06239363 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Pregnancy Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06239363 currently recruiting?
Yes, NCT06239363 is actively recruiting participants. Contact the research team at joanna.suliburska@up.poznan.pl for enrollment information.
Where is the NCT06239363 trial being conducted?
This trial is being conducted at Poznan, Poland.
Who is sponsoring the NCT06239363 clinical trial?
NCT06239363 is sponsored by Poznan University of Life Sciences. The trial plans to enroll 500 participants.