Gestational Changes in Hemodynamics and Respiratory Mechanics in Association With Pre-Eclampsia (TREMOFLO)
8 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
De observación
Inscripción (Estimado)
100
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Nicola F Tavella, MPH
- Número de teléfono: 212-241-3888
- Correo electrónico: nicola.tavella@mssm.edu
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10029
- Icahn School of Medicine at Mount Sinai
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Contacto:
- Nicola F Tavella, MPH
- Número de teléfono: 212-241-3888
- Correo electrónico: nicola.tavella@mssm.edu
-
Investigador principal:
- Angela Bianco, MD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Patients attending prenatal visits at Mount Sinai will be screened for eligibility by study staff.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Stroke Volume
Periodo de tiempo: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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The volume of blood pumped out of the left ventricle of the heart with each heartbeat.
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1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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Cardiac Output
Periodo de tiempo: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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The total volume of blood pumped out of the heart and into the rest of the body with each heartbeat.
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1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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Systemic Vascular Resistance
Periodo de tiempo: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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The level of force (or resistance) against which the heart must work to pump blood into the circulatory system.
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1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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Cardiac Index
Periodo de tiempo: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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A measure of the pumping capacity of the heart, calculated by dividing one's cardiac output by their body surface area.
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1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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R5
Periodo de tiempo: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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A respiratory measure of the resistance across all airways, both large and small, using 5Hz soundwaves.
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1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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R20
Periodo de tiempo: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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A respiratory measure of the resistance across central/large airways only, using 20Hz soundwaves.
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1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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X5
Periodo de tiempo: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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A respiratory measure of the elasticity of airways using 5Hz soundwaves to calculate the difference in energy to and from lung tissue.
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1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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Fres
Periodo de tiempo: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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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.
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1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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AX
Periodo de tiempo: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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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.
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1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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R5-R20
Periodo de tiempo: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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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.
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1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Gestational Hypertension
Periodo de tiempo: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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A state of high blood pressure triggered by the physiological changes specific to pregnancy.
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1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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Number of Preeclampsia
Periodo de tiempo: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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A pregnancy-related complication characterized by high blood pressure and systemic organ dysfunction that can be life-threatening.
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1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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Number of Fetal Growth Restriction
Periodo de tiempo: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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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).
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1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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Number of Spontaneous Preterm Birth
Periodo de tiempo: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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The spontaneous (labor not induced) delivery of a pregnancy before 37.0 weeks of gestation.
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1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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Number of Placental Abruption
Periodo de tiempo: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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A serious complication where the placenta detaches from the inside of the uterus prior to the delivery of the baby.
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1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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Number of Intensive Care Unit (ICU) Admission
Periodo de tiempo: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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Admission to the Intensive Care Unit (ICU) wherein a greater level of clinical surveillance and intervention is administered for higher severity cases.
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1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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Number of Adverse Neonatal Outcomes
Periodo de tiempo: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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Any adverse health outcomes experienced by the neonate following delivery (i.e., hypoglycemia, tachypnea, respiratory distress, acidemia).
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1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Angela Bianco, MD, Icahn School of Medicine at Mount Sinai
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de agosto de 2028
Finalización del estudio (Estimado)
1 de agosto de 2028
Fechas de registro del estudio
Enviado por primera vez
2 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de julio de 2026
Publicado por primera vez (Actual)
10 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY-26-00575
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
All of the individual participant data collected during the trial after deidentification.
Marco de tiempo para compartir IPD
Immediately following publication with no end date.
Criterios de acceso compartido de IPD
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).
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .