Heart rhythm and blood flow changes during pregnancy and after birth
Cardiovascular Research in EMbarazo and MAternity (EMMA). Study on Heart Rate Variability and Hemodynamic Adaptations During Pregnancy and Postpartum.
Fundacin Biomedica Galicia Sur · NCT07376616
This project will test whether measuring heart rate variability and blood pressure can track heart and circulation changes in pregnant people from the third month through the postpartum period.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 242 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fundacin Biomedica Galicia Sur (other) |
| Locations | 1 site (Vigo, Pontevedra) |
| Trial ID | NCT07376616 on ClinicalTrials.gov |
What this trial studies
This is an observational study that uses non-invasive measurements of heart rate variability (HRV) and blood pressure to document cardiovascular and autonomic changes during pregnancy and after delivery. Participants are enrolled from the third month of gestation and followed through the postpartum period with periodic monitoring visits. The study will correlate HRV measures with hemodynamic data to characterize normal adaptation and to explore patterns linked to complications. No experimental treatments are given; the focus is on measurement and pattern recognition.
Who should consider this trial
Good fit: Adults aged 18 or older who are pregnant from at least the third month of gestation, have no pre-existing cardiovascular disease, and can give informed consent are ideal candidates.
Not a fit: People with exclusions such as diabetes, chronic hypertension before pregnancy, thyroid disease, significant cardiac conditions, chronic kidney disease, major neurological disorders, or other listed conditions are not eligible and would likely not benefit from this protocol.
Why it matters
Potential benefit: If successful, these measurements could provide a simple, non-invasive way to monitor maternal cardiovascular health and help identify pregnancies at higher risk of complications earlier.
How similar studies have performed: Previous observational studies have shown pregnancy-related shifts in HRV and hemodynamics, but using these measures to reliably predict complications remains limited and is still being researched.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vigo, Pontevedra
- Hospital Alvaro Cunqueiro — Vigo, Pontevedra, Spain (RECRUITING)
Study contacts
- Principal investigator: Alicia González Represas — Instituto de Investigación Sanitaria Galicia Sur (IISGS)
- Study coordinator: Alicia González Represas
- Email: alicia@uvigo.gal
- Phone: 616044977
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pregnancy Related, Heart Rate Variation, Hemodynamics