TREMOFLO: Gestational Changes in Hemodynamics and Respiratory Mechanics in Association With Pre-eclampsia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Stroke Volume
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
- Number of Gestational Hypertension(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(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(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(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(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(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(1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum)
Investigators
Angela Bianco
Director, Division of Maternal-Fetal Medicine
Icahn School of Medicine at Mount Sinai