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Dietary Salt During Pregnancy and Maternal Vascular Function

J

Josip Juraj Strossmayer University of Osijek

Status

Unknown

Conditions

Pregnancy Related
Salt; Excess

Study type

Observational

Funder types

Other

Identifiers

NCT05048225
602-04/21-08/07

Details and patient eligibility

About

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.

Full 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

Enrollment

80 estimated patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

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

Trial design

80 participants in 4 patient groups

Low-salt (LS) group
Description:
intake of \< 5 g of salt per day
Normal-salt (NS) group
Description:
intake of 5 - 7.5 g of salt per day
High-salt (HS) group
Description:
intake of 7.5 - 10 g of salt per day
Very high-salt (VHS) group
Description:
intake of \> 10 g of salt per day

Trial contacts and locations

1

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Central trial contact

Martina Vulin, MD

Data sourced from clinicaltrials.gov

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