Evaluation of Hemodynamics in People With Untreated Preeclampsia Using Echocardiography

The goal of this observational trial is to determine the resting cardiac output (CO) using transthoracic echocardiography (TTE) in a cohort of people with untreated preeclampsia, and a cohort of healthy normotensive pregnant people.

Study Overview

• Status: Suspended
• Conditions: Preeclampsia
• Intervention / Treatment: Diagnostic test: Transthoracic Echocardiography

Detailed Description

This study seeks to evaluate cardiac output in people with untreated preeclampsia in a tertiary referral centre in the US. In doing so the investigators hope to better understand the underpinning of the pathophysiology of this condition and provide evidence for (or against) the new theory of the development of preeclampsia. The investigators also seek to examine CO changes at birth during cesarean delivery (CD) comparing healthy pregnant people with people with preeclampsia and further understand the changes in cardiac output (CO) after treatment with antihypertensive agents for preeclamptic patients so that the investigators may better rationale treatment with these agents and evaluate the changes that may occur at the time of CD and after cesarean birth in people with preeclampsia using TTE so that fluid therapy and blood pressure treatment can be prescribed based on hemodynamic findings. Further the investigators aim to imbed echocardiography into the management of people with preeclampsia and to determine the feasibility and long-term sustainability of conducting echocardiography studies in pregnant people with a multidisciplinary group at the Brigham and Women's Hospital Boston.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

80 pregnant people will be recruited; 40 with preeclampsia, and 40 healthy normotensive pregnant people.

Description

Inclusion Criteria:

Preeclampsia Participant.

1. Preclampsia definition: People with preeclampsia will be recruited at the time of diagnosis or suspected diagnosis of preeclampsia, according to accepted definitions of preeclampsia. Preeclampsia with severe features will be defined using the American College of Obstetrics and Gynecology definition.
2. Nulliparous, singleton pregnancy,
3. ≥20 weeks gestation
4. without any preexisting cardiovascular, hepatic, or respiratory problems,
5. No preexisting uterine abnormality including benign tumors, or placental adhesive disorder,
6. Not in labor,
7. Not with prior to treatment for preeclampsia,
8. Body mass index ≤ 40 kg/m2, age 18 to 50 years.

Healthy Participant:

Healthy pregnant people will be defined as

1. American Society of Anesthesiologists (ASA) Classification II with no significant medical or surgical illness,
2. Nulliparous (first pregnancy beyond 20 week's gestation)
3. Non-smokers, singleton pregnancy
4. Not having ruptured membranes
5. No uterine abnormalities
6. No placentation abnormalities.
7. Not receiving any vasoactive medication including salbutamol
8. Not on thyroid replacement hormones

Exclusion Criteria:

Preeclampsia Participant:

1. Multiparous, multiple pregnancy,
2. Previous cardiovascular, hepatic or respiratory problems
3. Gestational diabetes,
4. Hemodynamic or neurologically unstable patient
5. Unable to tolerate a 30-minute ultrasound examination (TTE)
6. Age less than 18 or greater than 50 years
7. BMI > 40 kg/m2,
8. Gestation < 20 weeks.

Healthy Participant:

1. Current administration of vasoactive drugs including salbutamol
2. Current administration of thyroxine
3. Pre-existing or gestational diabetes
4. Tobacco use
5. Pre-existing or gestational hypertension or preeclampsia
6. Known uterine abnormality, in labor or ruptured membranes
7. Unable to tolerate a 30-minute ultrasound examination (TTE)
8. Age less than 18 or greater than 50 years
9. BMI > 40 kg/m2,
10. Gestation < 20 weeks.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preeclampsia; People with preeclampsia will be recruited at the time of diagnosis or suspected diagnosis of preeclampsia, according to accepted definitions of preeclampsia,2 nulliparous, singleton pregnancy, ≥ 20 weeks' gestation, without any preexisting cardiovascular, hepatic, or respiratory problems, no preexisting uterine abnormality including benign tumors, or placental adhesive disorder, not in labor, prior to treatment for preeclampsia, body mass index ≤ 40 kg/m2, age 18 to 50 years. Preeclampsia with severe features will be defined using the American College of Obstetrics and Gynecology definition	Diagnostic test: Transthoracic Echocardiography; Cardiac output measured by transthoracic echocardiography (TTE)
Healthy Normotensive; Healthy pregnant people will be defined as American Society of Anesthesiologists (ASA) Classification II with no significant medical or surgical illness, nulliparous (first pregnancy beyond 20 weeks' gestation), non-smokers, singleton pregnancy with no uterine abnormalities and normally defined placentation. They will not be receiving any vasoactive medication including salbutamol or thyroid replacement hormones or have ruptured membranes.	Diagnostic test: Transthoracic Echocardiography; Cardiac output measured by transthoracic echocardiography (TTE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac output measured by transthoracic echocardiography (TTE) at rest: CO mL/min.	Cardiac output measured by transthoracic echocardiography (TTE)	During gestation (8 wks to 42 wks, during clinic or hospital visits) with diagnosis of Preeclampsia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac output measured by transthoracic echocardiography (TTE) after treatment with antihypertensive agents, and during CD and postpartum	Cardiac output measured by transthoracic echocardiography (TTE)	Post-treatment with antihypertensive (<60 min; during clinic or hospital ), Postpartum (cesarean or vaginal delivery; <60 min; immediately after to up to 6 hrs after delivery)

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Fulbright Foundation Scholar in Residence Program
• Investigators: Study Director: Alicia T Dennis, MBBS PhD MPH, University of Melbourne, Australia; Principal Investigator: Michaela Farber, MD, BWH

Publications and helpful links

General Publications

• Dennis AT, Castro JM. Echocardiographic differences between preeclampsia and peripartum cardiomyopathy. Int J Obstet Anesth. 2014 Aug;23(3):260-6. doi: 10.1016/j.ijoa.2014.05.002. Epub 2014 May 29.
• Dennis AT. Transthoracic echocardiography in women with preeclampsia. Curr Opin Anaesthesiol. 2015 Jun;28(3):254-60. doi: 10.1097/ACO.0000000000000182.
• Dennis AT, Castro JM. Transthoracic echocardiography in women with treated severe pre-eclampsia. Anaesthesia. 2014 May;69(5):436-44. doi: 10.1111/anae.12623. Epub 2014 Mar 27.

Study record dates

Study Major Dates

• Study Start (Estimated): October 25, 2026
• Primary Completion (Estimated): October 11, 2027
• Study Completion (Estimated): October 11, 2027

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; Preeclampsia; Antihypertensive Agents; Transthoracic Echocardiography
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Cardiac Imaging Techniques; Ultrasonography; Echocardiography
• Other Study ID Numbers: 2023P002364

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Results may be the genesis of an international collaborative effort

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No