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NCT Number: NCT07695909

Gestational Changes in Hemodynamics and Respiratory Mechanics in Association With Pre-Eclampsia

This study focuses on elucidating the changes of hemodynamics assessed by USCOM and respiratory mechanics assessed by impedance oscillometry (IOS) over the course of pregnancy and the postpartum period. Additionally, to understand how these changes over the course of gestation relate to the development of preeclampsia.

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Key information

Conditions

Pre-eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Post Partum Pregnancy Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Location contact

Angela Bianco, MD

PRINCIPAL_INVESTIGATOR

Nicola F Tavella, MPH

CONTACT

[email protected]

212-241-3888

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant patient
  • Aged 18-50 years old
  • Planning to deliver in Mount Sinai Health System

Exclusion criteria

  • Multiple gestation (i.e., twins)
  • Known fetal anomalies or genetic abnormalities

Treatment and study plan

Primary outcomes

  1. Stroke Volume

    Time frame: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

    The volume of blood pumped out of the left ventricle of the heart with each heartbeat.

  2. Cardiac Output

    Time frame: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

    The total volume of blood pumped out of the heart and into the rest of the body with each heartbeat.

  3. Systemic Vascular Resistance

    Time frame: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

    The level of force (or resistance) against which the heart must work to pump blood into the circulatory system.

  4. Cardiac Index

    Time frame: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

    A measure of the pumping capacity of the heart, calculated by dividing one's cardiac output by their body surface area.

  5. R5

    Time frame: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

    A respiratory measure of the resistance across all airways, both large and small, using 5Hz soundwaves.

  6. R20

    Time frame: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

    A respiratory measure of the resistance across central/large airways only, using 20Hz soundwaves.

  7. X5

    Time frame: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

    A respiratory measure of the elasticity of airways using 5Hz soundwaves to calculate the difference in energy to and from lung tissue.

  8. Fres

    Time frame: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

    This denotes the Resonant Frequency, which measures the frequency of soundwaves required to balance the internal forces of the lung tissue with its external capacity.

  9. AX

    Time frame: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

    Called the Area of Reactance, this is the measure of the area under the curve from the lowest measured frequency to the Resonant Frequency, and reflects the dysfunction of small airways.

  10. R5-R20

    Time frame: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

    A measure isolating the resistance of small airways, subtracting the R20 value from the R5 value to calculate the difference. Greater levels of this value correspond to greater small airway resistance.

Secondary outcomes

  1. Number of Gestational Hypertension

    Time frame: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

    A state of high blood pressure triggered by the physiological changes specific to pregnancy.

  2. Number of Preeclampsia

    Time frame: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

    A pregnancy-related complication characterized by high blood pressure and systemic organ dysfunction that can be life-threatening.

  3. Number of Fetal Growth Restriction

    Time frame: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

    A complication where the fetus is growing much less than expected for the gestational age of the pregnancy (i.e., estimated fetal weight and/or fetal abdominal circumstance less than the 10th percentile).

  4. Number of Spontaneous Preterm Birth

    Time frame: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

    The spontaneous (labor not induced) delivery of a pregnancy before 37.0 weeks of gestation.

  5. Number of Placental Abruption

    Time frame: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

    A serious complication where the placenta detaches from the inside of the uterus prior to the delivery of the baby.

  6. Number of Intensive Care Unit (ICU) Admission

    Time frame: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

    Admission to the Intensive Care Unit (ICU) wherein a greater level of clinical surveillance and intervention is administered for higher severity cases.

  7. Number of Adverse Neonatal Outcomes

    Time frame: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

    Any adverse health outcomes experienced by the neonate following delivery (i.e., hypoglycemia, tachypnea, respiratory distress, acidemia).

Study contacts

Contact information is provided by the study sponsor or research team.

Nicola F Tavella, MPH

CONTACT

[email protected]

212-241-3888

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

TREMOFLO: Gestational Changes in Hemodynamics and Respiratory Mechanics in Association With Pre-eclampsia

Acronym: TREMOFLO

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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