NCT07376616 Cardiovascular Research in EMbarazo and MAternity (EMMA). Study on Heart Rate Variability and Hemodynamic Adaptations During Pregnancy and Postpartum.
| NCT ID | NCT07376616 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundacin Biomedica Galicia Sur |
| Condition | Pregnancy Related |
| Study Type | OBSERVATIONAL |
| Enrollment | 242 participants |
| Start Date | 2025-05-19 |
| Primary Completion | 2027-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 242 participants in total. It began in 2025-05-19 with a primary completion date of 2027-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Over 18 years of age * Pregnancy from the third month of gestation * No pre-existing cardiovascular disease * Good cognitive level * Sign informed consent Exclusion Criteria: * 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
Contact & Investigator
Alicia González Represas
PRINCIPAL INVESTIGATOR
Instituto de Investigación Sanitaria Galicia Sur (IISGS)
Frequently Asked Questions
Who can join the NCT07376616 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pregnancy Related. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07376616 currently recruiting?
Yes, NCT07376616 is actively recruiting participants. Contact the research team at alicia@uvigo.gal for enrollment information.
Where is the NCT07376616 trial being conducted?
This trial is being conducted at Vigo, Spain.
Who is sponsoring the NCT07376616 clinical trial?
NCT07376616 is sponsored by Fundacin Biomedica Galicia Sur. The principal investigator is Alicia González Represas at Instituto de Investigación Sanitaria Galicia Sur (IISGS). The trial plans to enroll 242 participants.