Dietary Salt During Pregnancy and Maternal Vascular Function

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05048225
• Other study ID #: 602-04/21-08/07
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2021
• Source: Josip Juraj Strossmayer University of Osijek
• Contact: Martina Vulin, MD
• Phone: +38531512300
• Email: martina.vulin[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related
• Salt; Excess

Locations

Country	Name	City	State
Croatia	Osijek University Hospital	Osijek

Sponsors (1)

Lead Sponsor	Collaborator
Josip Juraj Strossmayer University of Osijek

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood pressure	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)
Other	Heart rate	Automatic oscillometric measurement of heart rate (bpm)	at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Other	Body mass index	Measurement of BMI (kg/m2)	at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Other	Body composition	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).	at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Other	Body fluid status	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).	at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Primary	Maternal systemic microvascular function	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)
Primary	Maternal systemic macrovascular function	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)
Primary	Maternal uteroplacental function	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)
Secondary	Oxidative stress - thiobarbituric acid reactive substances (TBARS)	Measurement of biomarkers of oxidative stress level. Thiobarbituric acid reactive substances (TBARS) - biomarker of lipid peroxidation.	at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Secondary	Matrix metalloproteinase 9	ELISA measurement of serum matrix metalloproteinase 9 level in mother serum and placental tissue sample (taken after childbirth)	at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy) (serum) and immediately after childbirth (placental tissue sample)
Secondary	Endocan	ELISA measurement of serum endocan level - proteoglycan associated with endothelium activation	at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Secondary	Pregnancy outcome - duration	Duration of pregnancy (weeks and days)	the outcome measure will be assessed at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Secondary	Pregnancy outcome - birth weight	Birth weight (in grams)	at one time point immediately after childbirth
Secondary	Pregnancy outcome - birth length	Birth length (in cm)	at one time point immediately after childbirth
Secondary	Pregnancy outcome - Apgar score	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)	at one time point immediately after childbirth