Dietary Salt During Pregnancy and Maternal Vascular Function

• Conditions: Pregnancy Related; Salt; Excess

• Registration Number: NCT05048225
• Lead Sponsor: Josip Juraj Strossmayer University of Osijek

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

Study Timeline

• Study First Submitted: 2021-06-08
• Status Verified: 2021-09
• Study Start: 2021-09-01
• Study First Submitted QC: 2021-09-08
• Study First Posted: 2021-09-17
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-27
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal uteroplacental function	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
Maternal systemic microvascular function	at 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 systemic macrovascular function	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)

Secondary Outcome Measures

Name	Time	Method
Pregnancy outcome - birth length	at one time point immediately after childbirth	Birth length (in cm)
Pregnancy outcome - Apgar score	at one time point immediately after childbirth	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)
Endocan	at 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
Pregnancy outcome - duration	the 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)
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.
Matrix metalloproteinase 9	at 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 - birth weight	at one time point immediately after childbirth	Birth weight (in grams)

Trial Locations

Locations (1)

Osijek University Hospital; 🇭🇷 Osijek, Croatia