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

NCT07695909 | Not Yet Recruiting

• 1 other identifier: STUDY-26-00575
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-eclampsia; Pregnancy; Post Partum

Outcome Measures

Primary Outcomes (10)

• Stroke Volume

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

Secondary Outcomes (7)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Angela Bianco, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola F Tavella, MPH

CONTACT

212-241-3888; nicola.tavella@mssm.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Maternal-Fetal Medicine

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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).

Locations

US (1)