Dietary Salt During Pregnancy and Maternal Vascular Function

NCT05048225 | Unknown

• 1 other identifier: 602-04/21-08/07
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Salt; Excess; Pregnancy Related

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (7)

• Oxidative stress - thiobarbituric acid reactive substances (TBARS)

  at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)

• 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)

• Endocan

  at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)

• Pregnancy outcome - duration

  the outcome measure will be assessed at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)

• Pregnancy outcome - birth weight

  at one time point immediately after childbirth

Other Outcomes (5)

• Blood pressure

  at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)

• Heart rate

  at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)

• Body mass index

  at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)

Study Arms (4)

Low-salt (LS) group

intake of \< 5 g of salt per day

Normal-salt (NS) group

intake of 5 - 7.5 g of salt per day

High-salt (HS) group

intake of 7.5 - 10 g of salt per day

Very high-salt (VHS) group

intake of \> 10 g of salt per day

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

healthy pregnant women in the third trimester of pregnancy (37-38 weeks of pregnancy)

You may qualify if:

• healthy pregnant women in the third trimester of pregnancy (37-38 weeks of pregnancy)

You may not qualify if:

• 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

Sponsors & Collaborators

• Josip Juraj Strossmayer University of Osijek: lead

Study Sites (1)

Osijek University Hospital

Osijek, 31000, Croatia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum, placental tissue

Study Officials

• Ines Drenjancevic, MD, PhD

  Faculty of Medicine Josip Juraj Strossmayer University of Osijek

  STUDY CHAIR

Central Study Contacts

Martina Vulin, MD

CONTACT

+38531512300; martina.vulin@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Physiology and Immunology Faculty of Medicine Osijek

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: September 17, 2021
• Study Start: September 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)