RecruitingNCT07376616

Cardiovascular Research in EMbarazo and MAternity (EMMA). Study on Heart Rate Variability and Hemodynamic Adaptations During Pregnancy and Postpartum.


Sponsor

Fundacin Biomedica Galicia Sur

Enrollment

242 participants

Start Date

May 19, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Heart rate variability (HRV) provides a non-invasive assessment of autonomic control of the nervous system over the heart. During pregnancy, the cardiovascular system adapts significantly, affecting HRV and hemodynamics. Studying the relationship between HRV and hemodynamic changes is critical to understanding and monitoring cardiovascular health during pregnancy and postpartum, and predicting potential complications.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • Over 18 years of age
  • Pregnancy from the third month of gestation
  • No pre-existing cardiovascular disease
  • Good cognitive level
  • Sign informed consent

Exclusion Criteria22

  • Diabetes mellitus
  • Hyperthyroidism
  • Hypothyroidism
  • Chronic hypertension diagnosed before pregnancy
  • Heart failure
  • Ischemic heart disease or malignant ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia, grade 2 or 3 AV block, atrial fibrillation in patients with Wolff-Parkinson- White syndrome, paroxysmal fibrillation or flutter with rapid ventricular response and hemodynamic deterioration, uncontrolled supraventricular tachycardia)
  • Exercise-induced ischaemia
  • Unstable angina
  • Disease not susceptible to revascularization
  • Associated valvular heart disease
  • Chronic kidney disease
  • Degenerative neurological condition
  • Brain aneurysms
  • Arteriovenous malformations
  • History of transient cerebral infarction (ICTUS)
  • Migraines diagnosed
  • Epilepsy
  • Brain or spinal cord injury
  • Tumors
  • Diseases of the respiratory tract
  • Diseases of lung tissue
  • Diseases of pulmonary circulation

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Interventions

OTHERAssessment of HRV and blood pressure

Assessment of Heart Rate Variation (HRV) and blood pressure


Locations(1)

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, Spain

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NCT07376616


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