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

ConditionsPregnancy RelatedHeart Rate Variation (HRV)Hemodynamics
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFundacin Biomedica Galicia Sur

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Over 18 years of age

Pregnancy from the third month of gestation

No pre-existing cardiovascular disease

Good cognitive level

Disqualifiers

Diabetes mellitus

Hyperthyroidism

Hypothyroidism

Chronic hypertension diagnosed before pregnancy

Trial population

Women pregnant from the first trimester of gestation over 18 years.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Assessment of HRV and blood pressure

    Other intervention

    Assessment of Heart Rate Variation (HRV) and blood pressure

Treatment groups

242 Participants
are divided into 1 treatment group
Group A: Unic group1 intervention

Trial outcomes

Primary outcomes

1

RR (R-R range)

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.

Time frame
Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
2

RMSSD (Root Mean Square of Successive Differences)

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.

Time frame
Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
3

pNN50 (Percentage of successive RR intervals differing by more than 50 ms)

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.

Time frame
Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.
4

HF (High Frecuency)

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).

Time frame
Pregnancy weeks 13, 27 and 41. Postpartum month, 3, 6 and 12 months.

Secondary outcomes

1

Age

Age expressed in years

Time frame
Basal assessment
2

Race

Caucasian, Black or of African descent, Arab or North African, Asian, Native American, Latin American, Other

Time frame
Basal assessment
3

Births

Nulliparous, primiparous, multiparous

Time frame
Basal assessment
4

Fertilization

Spontaneous, Conventional IVF, ICSI, FET (frozen embryos), Mini IVF, Ovodonation, ROPA Method

Time frame
Basal assessment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundacin Biomedica Galicia Sur

Lead sponsor

Source ClinicalTrials.gov
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