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Recruiting NCT07376616

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

— Observational Pregnancy Related Heart Rate Variation (HRV) Hemodynamics

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Assessment of HRV and blood pressure.
Who it may be relevant to
Registry conditions: Pregnancy Related, Heart Rate Variation (HRV), Hemodynamics. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Assessment of HRV and blood pressure
    Assessment of Heart Rate Variation (HRV) and blood pressure

Primary outcome measures

  • RR (R-R range) [Time frame: Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.]
  • RMSSD (Root Mean Square of Successive Differences) [Time frame: Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.]
  • pNN50 (Percentage of successive RR intervals differing by more than 50 ms) [Time frame: Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.]
  • HF (High Frecuency) [Time frame: Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.]
  • LF (low frequency) [Time frame: Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.]
  • SD1 (standard deviation 1) [Time frame: Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.]
  • SD2 (standard deviation 2) [Time frame: Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.]
  • DFAa1 (Trend Flotation Analysis, alpha-1) [Time frame: Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.]
  • DFAa2 (Trend Flotation Analysis, alpha-2) [Time frame: Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.]
  • SampEn (Sample Entropy) [Time frame: Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.]
Secondary outcome measures (12)
  • Age [Time frame: Basal assessment]
  • Race [Time frame: Basal assessment]
  • Births [Time frame: Basal assessment]
  • Fertilization [Time frame: Basal assessment]
  • Risk of pre-eclampsia [Time frame: Basal assessment]
  • Previous pregnancies [Time frame: Basal assessment]
  • Previous spontaneous abortions [Time frame: Basal assessment]
  • Type of childbirth [Time frame: Basal assessment]
  • Time of childbirth [Time frame: Basal assessment]
  • Level of education [Time frame: Basal assessment]
  • Employment status [Time frame: Basal assessment]
  • Concomitant medication [Time frame: Basal assessment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

Spain · 1 center
  • Hospital Alvaro Cunqueiro — Vigo

Identifiers

NCT: NCT07376616 · EMMA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗