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Dietary Salt During Pregnancy and Maternal Vascular Function

Influence of Dietary Salt Intake During Pregnancy on Maternal Systemic and Uteroplacental Vascular Function

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05048225
Enrollment
80
Registered
2021-09-17
Start date
2021-09-01
Completion date
2023-12-31
Last updated
2021-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Related, Salt; Excess

Keywords

salt intake, microcirculation, macrocirculation, endothelium, uteroplacental function, pregnancy, oxidative stress

Brief summary

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.

Detailed description

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

Interventions

None listed

Sponsors

Josip Juraj Strossmayer University of Osijek
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Maternal systemic microvascular functionat one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)Skin microvascular reactivity assessed by Laser Doppler flowmetry (post-occlusive reactive hyperemia, iontophoresis of acetylcholine and sodium nitroprusside) - measured in perfusion units (PU)
Maternal uteroplacental functionat 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
Maternal systemic macrovascular functionat one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)Vascular ultrasound measurement of brachial artery flow mediated dilation (FMD)

Secondary

MeasureTime frameDescription
Endocanat one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)ELISA measurement of serum endocan level - proteoglycan associated with endothelium activation
Matrix metalloproteinase 9at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy) (serum) and immediately after childbirth (placental tissue sample)ELISA measurement of serum matrix metalloproteinase 9 level in mother serum and placental tissue sample (taken after childbirth)
Pregnancy outcome - durationthe outcome measure will be assessed at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)Duration of pregnancy (weeks and days)
Pregnancy outcome - birth weightat one time point immediately after childbirthBirth weight (in grams)
Pregnancy outcome - birth lengthat one time point immediately after childbirthBirth length (in cm)
Pregnancy outcome - Apgar scoreat one time point immediately after childbirthApgar score (in Apgar score scale, a total score of 1 to 10; the higher the score, the better the baby is doing after birth)
Oxidative stress - thiobarbituric acid reactive substances (TBARS)at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)Measurement of biomarkers of oxidative stress level. Thiobarbituric acid reactive substances (TBARS) - biomarker of lipid peroxidation.

Other

MeasureTime frameDescription
Body fluid statusat one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)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).
Body compositionat one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)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).
Body mass indexat one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)Measurement of BMI (kg/m2)
Blood pressureat 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)
Heart rateat one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)Automatic oscillometric measurement of heart rate (bpm)

Countries

Croatia

Contacts

Primary ContactMartina Vulin, MD
martina.vulin@gmail.com+38531512300

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026