Dietary Salt During Pregnancy and Maternal Vascular Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dietary Salicylates and Preeclampsia

NCT06239363

Pregnancy Disease Preeclampsia Diet Habit

RECRUITING

Vascular Effects of High-Salt After Preeclampsia

NCT06749418

Preeclampsia Preeclampsia Postpartum

RECRUITING EARLY_PHASE1

Circulating Oxidative Stress and Gestational Hypertension. Study of the Evolution of Free-radical Markers of Oxidative Stress From Before to After Childbirth in Two Groups of Women: Normal Pregnancy and Pre-eclampsia.

NCT01907620

Pregnancy Complicated by Pre-eclampsia. Normal Pregnancy

COMPLETED NA

Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclampsia

NCT03482440

Preeclampsia

COMPLETED EARLY_PHASE1

Plasma Brain Natriuretic Peptide Levels in Pregnancy

NCT00324402

Cardiomyopathy Pregnancy

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Salt; Excess Pregnancy Related

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low-salt (LS) group

intake of \< 5 g of salt per day

No interventions assigned to this group

Normal-salt (NS) group

intake of 5 - 7.5 g of salt per day

No interventions assigned to this group

High-salt (HS) group

intake of 7.5 - 10 g of salt per day

No interventions assigned to this group

Very high-salt (VHS) group

intake of \> 10 g of salt per day

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes