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Not yet recruitingNCT07695909TREMOFLOUpdated Sep 28, 2026

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

An observational study in Pre-eclampsia, Pregnancy and Post Partum, sponsored by Icahn School of Medicine at Mount Sinai. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Icahn School of Medicine at Mount Sinai · Observational

Updated Sep 28, 2026Start date movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 50 Years
Sex
Female
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Study summary

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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Conditions studied

  • Pre-eclampsia
  • Pregnancy
  • Post Partum

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03

In context

Pre-Eclampsia

916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.

This study's planned enrollment of 100 is below the median of 165 across 397 observational studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.

Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients attending prenatal visits at Mount Sinai will be screened for eligibility by study staff.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Multiple gestation (i.e., twins)
  • Known fetal anomalies or genetic abnormalities
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Observational Group

    During pregnancy and the post-partum period, participants enrolled in this study will have observational hemodynamic and oscillometer measurements taken which will be analyzed alongside individuals' pregnancy outcomes as they relate to hypertensive disorders of pregnancy and, specifically, pre-eclampsia.

06

What researchers measure

Primary outcomes

  1. Stroke Volume

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

    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

  2. Cardiac Output

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

    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

  3. Systemic Vascular Resistance

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

    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

  4. Cardiac Index

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

    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

  5. R5

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

    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

  6. R20

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

    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

  7. X5

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

    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

  8. Fres

    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.

    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

  9. AX

    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.

    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

  10. R5-R20

    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.

    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

Secondary outcomes

  1. Number of Gestational Hypertension

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

    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

  2. Number of Preeclampsia

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

    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

  3. Number of Fetal Growth Restriction

    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).

    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

  4. Number of Spontaneous Preterm Birth

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

    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

  5. Number of Placental Abruption

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

    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

  6. Number of Intensive Care Unit (ICU) Admission

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

    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

  7. Number of Adverse Neonatal Outcomes

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

    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

07

Study locations

1 site
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References and documents

Individual participant data

Plan to share: Yes — All of the individual participant data collected during the trial after deidentification.

Supporting information: Study protocol, Informed consent form

Time frame: Immediately following publication with no end date.

Access criteria: Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link tbd).

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Start date
Sep 2026→Oct 2026
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Start date Sep 2026→Oct 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07695909
Responsible party
Angela Bianco (Director, Division of Maternal-Fetal Medicine, Icahn School of Medicine at Mount Sinai) — Principal investigator
First posted
Jul 10, 2026
Start date
Oct 2026 (estimated)
Primary completion
Aug 2028 (estimated)
Completion
Aug 2028 (estimated)
Last update
Sep 28, 2026

Study contacts

Nicola F Tavella, MPH
Contact
nicola.tavella@mssm.edu
212-241-3888
Angela Bianco, MD
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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