Dietary Salt During Pregnancy and Maternal Vascular Function
20 september 2021 bijgewerkt door: Ines Drenjancevic, Josip Juraj Strossmayer University of Osijek
Influence of Dietary Salt Intake During Pregnancy on Maternal Systemic and Uteroplacental Vascular Function
The main goal of this study is to investigate the association of dietary salt intake during pregnancy with systemic micro- and macrovascular reactivity and uteroplacental vascular function of the mother, and to examine the potential impact of elevated oxidative stress on this association.
Also, the aim is to investigate whether there is an association between excessive salt intake during pregnancy and the outcome of pregnancy.
Studie Overzicht
Toestand
Werving
Conditie
Gedetailleerde beschrijving
During the study pregnant women at the third trimester of pregnancy (37-38 weeks of pregnancy) will have one study visit during which following procedures will be done:
- measurement of maternal systemic microvascular function by Laser Doppler flowmetry (post-occlusive reactive hyperemia, iontophoresis of acetylcholine and sodium nitroprusside)
- measurement of maternal systemic macrovascular function by vascular ultrasound measurement of brachial artery flow mediated dilation (FMD)
- measurement of maternal uteroplacental function by ultrasound color Doppler measurement of umbilical artery and fetal middle cerebral artery blood flow
- venous blood sampling; serum will be stored for measurement of oxidative stress, matrix metalloproteinase 9 and endocan level
- 24-hour urine natriuresis (to estimate daily salt intake)
- measurement of blood pressure, heart rate, height and weight, body composition
Immediately after the childbirth following procedures will be done:
- assessment of pregnancy outcome (duration of pregnancy, child birth weight, child birth length and Apgar score)
- placental tissue will be taken and stored for measurement of matrix metalloproteinase 9
Studietype
Observationeel
Inschrijving (Verwacht)
80
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Martina Vulin, MD
- Telefoonnummer: +38531512300
- E-mail: martina.vulin@gmail.com
Studie Locaties
-
-
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Osijek, Kroatië, 31000
- Werving
- Osijek University Hospital
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Contact:
- Martina Vulin, MD
- Telefoonnummer: +385 31 512 300
- E-mail: martina.vulin@gmail.com
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Vrouw
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
healthy pregnant women in the third trimester of pregnancy (37-38 weeks of pregnancy)
Beschrijving
Inclusion Criteria:
- healthy pregnant women in the third trimester of pregnancy (37-38 weeks of pregnancy)
Exclusion Criteria:
- smoking
- prenatal hypertension
- thrombophilia
- low molecular weight heparin use
- coronary heart disease
- preconception diabetes
- gestational diabetes
- renal impairment
- cerebrovascular and peripheral artery disease
- any other preconception disease that could affect vascular and endothelial function
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
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Low-salt (LS) group
intake of < 5 g of salt per day
|
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Normal-salt (NS) group
intake of 5 - 7.5 g of salt per day
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High-salt (HS) group
intake of 7.5 - 10 g of salt per day
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Very high-salt (VHS) group
intake of > 10 g of salt per day
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Maternal systemic microvascular function
Tijdsspanne: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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Skin microvascular reactivity assessed by Laser Doppler flowmetry (post-occlusive reactive hyperemia, iontophoresis of acetylcholine and sodium nitroprusside) - measured in perfusion units (PU)
|
at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
|
Maternal systemic macrovascular function
Tijdsspanne: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
Vascular ultrasound measurement of brachial artery flow mediated dilation (FMD)
|
at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
|
Maternal uteroplacental function
Tijdsspanne: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
Ultrasound color Doppler measurement of umbilical artery and fetal middle cerebral artery blood flow
|
at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Oxidative stress - thiobarbituric acid reactive substances (TBARS)
Tijdsspanne: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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Measurement of biomarkers of oxidative stress level.
Thiobarbituric acid reactive substances (TBARS) - biomarker of lipid peroxidation.
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
|
Matrix metalloproteinase 9
Tijdsspanne: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy) (serum) and immediately after childbirth (placental tissue sample)
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ELISA measurement of serum matrix metalloproteinase 9 level in mother serum and placental tissue sample (taken after childbirth)
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy) (serum) and immediately after childbirth (placental tissue sample)
|
|
Endocan
Tijdsspanne: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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ELISA measurement of serum endocan level - proteoglycan associated with endothelium activation
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
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Pregnancy outcome - duration
Tijdsspanne: the outcome measure will be assessed at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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Duration of pregnancy (weeks and days)
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the outcome measure will be assessed at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
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Pregnancy outcome - birth weight
Tijdsspanne: at one time point immediately after childbirth
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Birth weight (in grams)
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at one time point immediately after childbirth
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Pregnancy outcome - birth length
Tijdsspanne: at one time point immediately after childbirth
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Birth length (in cm)
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at one time point immediately after childbirth
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Pregnancy outcome - Apgar score
Tijdsspanne: at one time point immediately after childbirth
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Apgar score (in Apgar score scale, a total score of 1 to 10; the higher the score, the better the baby is doing after birth)
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at one time point immediately after childbirth
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Blood pressure
Tijdsspanne: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
Automatic oscillometric measurement of systolic and diastolic blood pressure (in mmHg)
|
at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
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Heart rate
Tijdsspanne: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
Automatic oscillometric measurement of heart rate (bpm)
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
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Body mass index
Tijdsspanne: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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Measurement of BMI (kg/m2)
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
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Body composition
Tijdsspanne: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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Body composition and body fluid status measurement by a four-terminal portable impedance analyzer.
Based on the value of skin resistance (Ohm) empirically derived formulas (the original manufacturer's software) will be used to calculate the estimated Fat Free Mass (FFM kg) and Fat (Fat Mass kg).
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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Body fluid status
Tijdsspanne: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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Body fluid status measurement by a four-terminal portable impedance analyzer.
Based on the value of skin resistance (Ohm) empirically derived formulas (the original manufacturer's software) will be used to calculate the estimated Total Body Water (TBW L), Extracellular Water (ECW L), Intracellular Water (ICW L), Plasma Fluid (PF L) and Interstitial Fluid (IF L).
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Studie stoel: Ines Drenjančević, MD, PhD, Faculty of Medicine Josip Juraj Strossmayer University of Osijek
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 september 2021
Primaire voltooiing (Verwacht)
31 december 2022
Studie voltooiing (Verwacht)
31 december 2023
Studieregistratiedata
Eerst ingediend
8 juni 2021
Eerst ingediend dat voldeed aan de QC-criteria
8 september 2021
Eerst geplaatst (Werkelijk)
17 september 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
27 september 2021
Laatste update ingediend die voldeed aan QC-criteria
20 september 2021
Laatst geverifieerd
1 september 2021
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 602-04/21-08/07
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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