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

Condition(s) studied

Investigational drug(s) / intervention(s)

Assessment of HRV and blood pressure: Assessment of Heart Rate Variation (HRV) and blood pressure

Study 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

Primary outcome measure(s)

• RR (R-R range) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  The RR interval is the time between successive R-waves of the QRS complex now electrocardiogram (ECG) expressed in milliseconds (ms). It is a fundamental unit in HRV analysis and represents the time between two consecutive heartbeats.
• RMSSD (Root Mean Square of Successive Differences) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  RMSSD is a measure in the tempo domain that quantifies variability in the length of consecutive RR intervals expressed in milliseconds (ms). It reflects short-term HRV and is influenced by the parasympathetic nervous system.
• pNN50 (Percentage of successive RR intervals differing by more than 50 ms) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  pNN50 is another measure in the time domain that represents a percentage (%) of RR intervals that differ by more than 50 ms. It is also indicative of short-term HRV and is related to parasympathetic activity.
• HF (High Frecuency) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  HF is a measurement in the frequency domain that represents the power of heart rate variability in the high frequency range (typically 0.15 to 0.4 Hz). It is associated with parasympathetic (vagal) activity and is often analyzed by spectral analysis of the HRV signal. Expressed in milliseconds squared (ms\^2).
• LF (low frequency) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  LF is a measurement in the frequency domain that represents the power of heart rate variability at low frequencies (usually from 0.04 to 0.15 Hz). The LF is influenced by sympathetic and parasympathetic activity and the child analyzase xunto coa IC. Expressed in milliseconds to frame (ms\^2).
• SD1 (standard deviation 1) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  SD1 is xeometric measures derived from Poincaré graphs, which are graphical representations of RR intervals. SD1 represents the short-term variability perpendicular to the identity line in the Poincaré graphic and is influenced by parasympathetic activity.
• SD2 (standard deviation 2) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  SD2 is a xeometric measure derived from Poincaré graphs, which are graphical representations of RR intervals. SD2 represents long-term variability along the identity line and is influenced by sympathetic and parasympathetic activity.
• DFAa1 (Trend Flotation Analysis, alpha-1) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  DFA is a mathematical method used to evaluate fractal properties in time series, such as the HRV. DFAa1 centrase specifically in short-term floatation (alpha-1) in the HRV signal. It offers information about the properties of autosemellanza or long-range correlation of the signal.
• DFAa2 (Trend Flotation Analysis, alpha-2) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  DFA is a mathematical method used to evaluate the fractal properties of time series, such as HRV. DFAa2 céntrase especially in long-term flotation (alpha-2) in the HRV signal.
• SampEn (Sample Entropy) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  The show entropy is a modified algorithm less dependent on the duration of the time series. Used to evaluate the complexity of R-R intervals. A higher entropy value represents more complex dynamics and greater ability of the cardiovascular system to adapt to changes, which is associated with lower cardiovascular health.
• ApEn (approximate entropy) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  ApEn is a measure used to evaluate the regularity and complexity of time series, such as HRV. ApEn quantifies the degree of unpredictability in the time series fluctuations, providing information about the structure of the signal and its irregularity. A lower value of ApEn indicates a more regular and predictable series, whereas a higher value reflects greater complexity and irregularity.
• MSE (Multiscale entropy) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  MSE is an extension of SampEn that analyzes the complexity of time series on multiple time scales. The MSE allows to evaluate the structure of the signal at different levels of detail, providing a more complete view of its complexity.
• D2 (Correlation dimension) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  The correlation dimension is a measure that estimates the minimum number of variables needed to build a model of the dynamics of a system. The greater the number of variables required to predict a time series, the greater its complexity. This measure provides information about the subcomplex and dynamic characteristics of the system.
• Heart rate turbulence (HRT) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  The cardiac frequency turbulence and a baroreflex-mediated axus of the cardiac frequency that acts as a countermechanism for premature ventricular contraction. It consists of no brief acceleration of the heart rate, followed by a slow decrease at the reference rate.
• Heart rate (HR) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  Number of heartbeats per minute during treatments performed during different trimesters of pregnancy and not postpartum (Lat/min).
• Systolic blood pressure (PAS) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  Perform a systolic blood pressure record expressed in mmHg and measured in different locations.
• Diastolic blood pressure (DBP) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  Perform a diastolic blood pressure record expressed in mmHg and measured in different locations.
• Mean arterial pressure (MAP) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  MAP is the constant blood pressure value that, wedge same peripheral resistance would produce the same flow rate (minute cardiac volume) as xera a variable blood pressure (systolic and diastolic pressure) expressed in mmHg.
• Pulse pressure (BP) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  BP is an index of arterial distensibility expressed in mmHg obtained from the difference between systolic and diastolic blood pressure and measured in different locations.
• O2 saturation — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  Oxygen saturation measures, in different locations, the percentage of hemoglobin in red blood cells currently transporting oxygen, indicating how well the lungs and heart are oxygenating body tissues. The following are measured: Regional O2 saturation (StO2) using near-infrared spectroscopy (NIRS), Arterial O2 saturation (SpO2) uses standard pulse oximetry, Venous O2 saturation (SjvO2) requires invasive catheterization.
• Cardiac output (CO) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  Cardiac output is the total volume of blood pumped by the heart's left ventricle in one minute, serving as a critical indicator of cardiovascular health and tissue perfusion. It is measured in L/min multiplying the stroke volume (blood ejected per beat) by the heart rate (beats per minute) using an echocardiogram.
• Stroke volume (SV) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  Stroke volume is the volume of blood pumped from the left ventricle per beat. It is measured in mL using a volumetric formula whose values are obtained from cardiac imaging and hemodynamic monitoring techniques, such as echocardiography.
• Systemic vascular resistance (SRV) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  Systemic vascular resistance is measured by calculating the opposition to blood flow in the left ventricle using a formula. The essential values are mean arterial pressure (MAP), central venous pressure (CVP), and cardiac output (CO), usually obtained through invasive catheterization (Swan-Ganz catheter) or advanced hemodynamic monitoring methods. It is measured in dyn\*s/cm\^5
• Vasodilation / Constriction (VDCx) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  Vasodilation (widening) and vasoconstriction (narrowing) of blood vessels (VDCx), which reflect vascular function and muscle tone, are measured in mm using non-invasive techniques that assess how an artery reacts to a stimulus. The standard method is Flow-Mediated Dilation (FMD) using ultrasound.
• Cerebral vascular flow (CBF) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  Cerebral blood flow is the net amount of blood delivered to the brain's capillary bed per unit of time and tissue mass, typically measured in mL/min/100g using various imaging and functional monitoring techniques, mainly classified into non-invasive methods (ultrasound, MRI) and perfusion techniques by tomography or nuclear medicine, intended to assess the amount and speed of blood reaching brain tissue.
• Cardiac Index (CI) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  The Cardiac Index is a hemodynamic parameter representing the heart's pumping efficiency, calculated as the cardiac output divided by the body surface area. It measures blood flow (liters per minute) relative to a person's size L/min/m\^2 using Doppler Echocardiography.
• Central Venous Pressure (CVP) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  Central Venous Pressure is measured by connecting a central venous catheter to a manometer or electronic transducer, aligning the equipment with the phlebostatic point (level of the right atrium), and reading the fluid column (cm H2O) or the figure in mmHg that indicates the hydroelectrolytic balance and function of the right side of the heart, reflecting intravascular volume and cardiac preload.
• Jugular venous distensibility (JVDx/JYI-DI) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  Jugular venous distensibility is an index given by a formula whose data is obtained from ultrasound measurement to evaluate the response in the change of diameter of the veins to fluids and the volemia status.
• The Ankle-Brachial Index with Doppler (ABI-D or ITB) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  The Ankle-Brachial Index with Doppler is a non-invasive diagnostic test used to evaluate peripheral arterial disease (PAD) by comparing systolic blood pressure at the ankle with that in the arm. It is measured by dividing the highest systolic pressure obtained at the ankle by the highest systolic pressure in the arms.
• The Cardio-Ankle Vascular Index (CAVI) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  The Cardio-Ankle Vascular Index is measured non-invasively using a specialized device, commonly the VaSera (Fukuda Denshi, Japan), which automatically calculates stiffness from the origin of the aorta to the ankle. The procedure is based on pulse wave velocity (PWV) and blood pressure.
• The Acoustic Index Derived (AI-D) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  The Acoustic Index Derived is a new metric in cardiology that is measured using AI-assisted automated echocardiography to assess cardiac function in real time. It is calculated by automatically analyzing ultrasound images to provide a comprehensive view of heart health.
• PEP (Pre-Ejection Period) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  The PEP (Pre-Ejection Period) in hemodynamics is a parameter measured in milliseconds (ms) that evaluates the time that elapses from the beginning of the electrical activation of the ventricle until the beginning of the ejection of blood towards the aorta. It is measured by calculating the time interval between the start of ventricular depolarization (Q wave of the ECG) and the beginning of aortic blood ejection (point B of impedance cardiography).
• Ejection Time (ET) — Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
  Ejection Time (ET) is the duration of systolic flow, measuring (in milliseconds) the time interval from aortic valve opening to closure when the left ventricle ejects blood into the aorta. Using Spectral Doppler (Pulsed or Continuous Wave) the time is measured from the start of the flow (valve opening) to the end of the aortic flow (valve closing).

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