Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06239363 |
| Other study ID # |
34/2023 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 8, 2024 |
| Est. completion date |
September 30, 2027 |
Study information
| Verified date |
February 2024 |
| Source |
Poznan University of Life Sciences |
| Contact |
Joanna Suliburska, Professor |
| Phone |
+48 61 8487260 |
| Email |
joanna.suliburska[@]up.poznan.pl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
