Evaluation of Hemodynamics in People With Untreated Preeclampsia Using Echocardiography

NCT06099275 | Suspended FDA Device

• 1 other identifier: 2023P002364
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preeclampsia

Keywords

Preeclampsia; Transthoracic Echocardiography; Antihypertensive Agents; Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• cardiac output measured by transthoracic echocardiography (TTE) after treatment with antihypertensive agents, and during CD and postpartum

  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)

Study Arms (2)

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

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

Interventions

Transthoracic Echocardiography DIAGNOSTIC_TEST

Cardiac output measured by transthoracic echocardiography (TTE)

Healthy Normotensive; Preeclampsia

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Pregnant People
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Preeclampsia Participant.
• 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.
• 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,
• Not with prior to treatment for preeclampsia,
• Body mass index ≤ 40 kg/m2, age 18 to 50 years.
• Healthy Participant:
• 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 week's gestation)
• Non-smokers, singleton pregnancy
• Not having ruptured membranes

You may not qualify if:

• Preeclampsia Participant:
• Multiparous, multiple pregnancy,
• Previous cardiovascular, hepatic or respiratory problems
• Gestational diabetes,
• Hemodynamic or neurologically unstable patient
• Unable to tolerate a 30-minute ultrasound examination (TTE)
• Age less than 18 or greater than 50 years
• BMI \> 40 kg/m2,
• Gestation \< 20 weeks.
• Healthy Participant:
• Current administration of vasoactive drugs including salbutamol
• Current administration of thyroxine
• Pre-existing or gestational diabetes
• Tobacco use
• Pre-existing or gestational hypertension or preeclampsia

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Fulbright Foundation Scholar in Residence Program: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

• 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.

  PMID: 24986564 BACKGROUND

• Dennis AT. Transthoracic echocardiography in women with preeclampsia. Curr Opin Anaesthesiol. 2015 Jun;28(3):254-60. doi: 10.1097/ACO.0000000000000182.

  PMID: 25812006 RESULT

• 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.

  PMID: 24673113 RESULT

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Michaela Farber, MD

  BWH

  PRINCIPAL INVESTIGATOR

• Alicia T Dennis, MBBS PhD MPH

  University of Melbourne, Australia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Harvard Medical School

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 25, 2023
• Study Start (Estimated): October 25, 2026
• Primary Completion (Estimated): October 11, 2027
• Study Completion (Estimated): October 11, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)