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

24 september 2026 bijgewerkt door: Angela Bianco, Icahn School of Medicine at Mount Sinai

TREMOFLO: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Studietype

Observationeel

Inschrijving (Geschat)

100

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • New York
      • New York, New York, Verenigde Staten, 10029
        • Icahn School of Medicine at Mount Sinai
        • Contact:
        • Hoofdonderzoeker:
          • Angela Bianco, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 50 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Stroke Volume
Tijdsspanne: 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.
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
Cardiac Output
Tijdsspanne: 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.
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
Systemic Vascular Resistance
Tijdsspanne: 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.
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
Cardiac Index
Tijdsspanne: 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.
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
R5
Tijdsspanne: 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.
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
R20
Tijdsspanne: 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.
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
X5
Tijdsspanne: 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.
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
Fres
Tijdsspanne: 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.
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
AX
Tijdsspanne: 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.
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
R5-R20
Tijdsspanne: 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.
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Gestational Hypertension
Tijdsspanne: 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.
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
Number of Preeclampsia
Tijdsspanne: 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.
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
Number of Fetal Growth Restriction
Tijdsspanne: 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).
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
Number of Spontaneous Preterm Birth
Tijdsspanne: 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.
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
Number of Placental Abruption
Tijdsspanne: 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.
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
Number of Intensive Care Unit (ICU) Admission
Tijdsspanne: 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.
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
Number of Adverse Neonatal Outcomes
Tijdsspanne: 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).
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Icahn School of Medicine at Mount Sinai

Onderzoekers

  • Hoofdonderzoeker: Angela Bianco, MD, Icahn School of Medicine at Mount Sinai

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 augustus 2028

Studie voltooiing (Geschat)

1 augustus 2028

Studieregistratiedata

Eerst ingediend

2 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 juli 2026

Eerst geplaatst (Werkelijk)

10 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 september 2026

Laatste update ingediend die voldeed aan QC-criteria

24 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STUDY-26-00575

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

All of the individual participant data collected during the trial after deidentification.

IPD-tijdsbestek voor delen

Immediately following publication with no end date.

IPD-toegangscriteria voor delen

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).

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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