Clinical trial NCT05048225: Dietary Salt During Pregnancy and Maternal Vascular Function
Official title: Influence of Dietary Salt Intake During Pregnancy on Maternal Systemic and Uteroplacental Vascular Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Salt; Excess
Pregnancy Related
Keywords: salt intake
microcirculation
macrocirculation
endothelium
uteroplacental function
pregnancy
oxidative stress
Lead sponsor: Josip Juraj Strossmayer University of Osijek
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: healthy pregnant women in the third trimester of pregnancy (37-38 weeks of pregnancy)

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

Eligibility criteria: 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

Primary outcomes:
measure: Maternal systemic microvascular function
timeFrame: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
measure: Maternal systemic macrovascular function
timeFrame: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
measure: Maternal uteroplacental function
timeFrame: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Secondary outcomes:
measure: Oxidative stress - thiobarbituric acid reactive substances (TBARS)
timeFrame: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
measure: Matrix metalloproteinase 9
timeFrame: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy) (serum) and immediately after childbirth (placental tissue sample)
measure: Endocan
timeFrame: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
measure: Pregnancy outcome - duration
timeFrame: the outcome measure will be assessed at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
measure: Pregnancy outcome - birth weight
timeFrame: at one time point immediately after childbirth
measure: Pregnancy outcome - birth length
timeFrame: at one time point immediately after childbirth
measure: Pregnancy outcome - Apgar score
timeFrame: at one time point immediately after childbirth
Other outcomes:
measure: Blood pressure
timeFrame: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
measure: Heart rate
timeFrame: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
measure: Body mass index
timeFrame: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
measure: Body composition
timeFrame: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
measure: Body fluid status
timeFrame: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Locations:
city: Osijek
country: Croatia
facility: Osijek University Hospital
Study officials:
affiliation: Faculty of Medicine Josip Juraj Strossmayer University of Osijek
name: Ines Drenjancevic, MD, PhD
role: STUDY_CHAIR
References: