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Dietary Salt During Pregnancy and Maternal Vascular Function

20. september 2021 oppdatert av: Ines Drenjancevic, Josip Juraj Strossmayer University of Osijek

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

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.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

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

Studietype

Observasjonsmessig

Registrering (Forventet)

80

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kroatia
      • Osijek, Kroatia, 31000
        • Rekruttering
        • Osijek University Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maternal systemic microvascular function
Tidsramme: 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)
at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Maternal systemic macrovascular function
Tidsramme: 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)
at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Maternal uteroplacental function
Tidsramme: 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
at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Oxidative stress - thiobarbituric acid reactive substances (TBARS)
Tidsramme: 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.
at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Matrix metalloproteinase 9
Tidsramme: 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)
at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy) (serum) and immediately after childbirth (placental tissue sample)
Endocan
Tidsramme: 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
at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Pregnancy outcome - duration
Tidsramme: 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)
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
Tidsramme: at one time point immediately after childbirth
Birth weight (in grams)
at one time point immediately after childbirth
Pregnancy outcome - birth length
Tidsramme: at one time point immediately after childbirth
Birth length (in cm)
at one time point immediately after childbirth
Pregnancy outcome - Apgar score
Tidsramme: 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)
at one time point immediately after childbirth

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Blood pressure
Tidsramme: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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)
Heart rate
Tidsramme: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Automatic oscillometric measurement of heart rate (bpm)
at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Body mass index
Tidsramme: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Measurement of BMI (kg/m2)
at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Body composition
Tidsramme: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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)
Body fluid status
Tidsramme: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Josip Juraj Strossmayer University of Osijek

Etterforskere

  • Studiestol: Ines Drenjančević, MD, PhD, Faculty of Medicine Josip Juraj Strossmayer University of Osijek

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. september 2021

Primær fullføring (Forventet)

31. desember 2022

Studiet fullført (Forventet)

31. desember 2023

Datoer for studieregistrering

Først innsendt

8. juni 2021

Først innsendt som oppfylte QC-kriteriene

8. september 2021

Først lagt ut (Faktiske)

17. september 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. september 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. september 2021

Sist bekreftet

1. september 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 602-04/21-08/07

Plan for individuelle deltakerdata (IPD)

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NEI

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Nei

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