PreeclampsiaNCT06099275
Evaluation of Hemodynamics in People With Untreated Preeclampsia Using Echocardiography
An observational study of Preeclampsia, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Transthoracic Echocardiography
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2026to 11 Oct 2027
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 80 pregnant people will be recruited; 40 with preeclampsia, and 40 healthy normotensive pregnant people.
Who may be able to join
- 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,
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- 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
- No uterine abnormalities
- No placentation abnormalities.
- Not receiving any vasoactive medication including salbutamol
- Not on thyroid replacement hormones
Who cannot join
- 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)
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- 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
- Known uterine abnormality, in labor or ruptured membranes
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Preeclampsia
- Being tested
- Transthoracic Echocardiography
- Keywords
- Preeclampsia, Transthoracic Echocardiography, Antihypertensive Agents, Pregnancy
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic EchocardiographyDiagnostic test
Cardiac output measured by transthoracic echocardiography (TTE)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Diagnostic Test: Transthoracic Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output measured by transthoracic echocardiography (TTE) at rest: CO mL/min.
Cardiac output measured by transthoracic echocardiography (TTE)
Measured: 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
Cardiac output measured by transthoracic echocardiography (TTE)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start25 Oct 2026 (estimated)
- Primary completion11 Oct 2027 (estimated)
- Study completion11 Oct 2027 (estimated)
Why it stopped: inadequate funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fulbright Foundation Scholar in Residence Program
- Responsible party
- Principal investigator, Michaela Kristina Farber, MD, Brigham and Women's Hospital
- Investigators
- Michaela Farber, MD, Principal investigator, BWHAlicia T Dennis, MBBS PhD MPH, Study director, University of Melbourne, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099275
- Sponsor's protocol ID
- 2023P002364
- Status last verified
- Jan 2026
- First submitted
- 11 Oct 2023
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Results may be the genesis of an international collaborative effort
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.
PubMed 24986564Dennis AT. Transthoracic echocardiography in women with preeclampsia. Curr Opin Anaesthesiol. 2015 Jun;28(3):254-60. doi: 10.1097/ACO.0000000000000182.
PubMed 25812006Dennis 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.
PubMed 24673113
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hemodynamics in People With Untreated Preeclampsia Using Echocardiography
- ClinicalTrials.gov ID
- NCT06099275
- Acronym / sponsor ID
- 2023P002364
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, Transthoracic Echocardiography, Antihypertensive Agents, Pregnancy
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: inadequate funding
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Fulbright Foundation Scholar in Residence Program
- Study start
- 25 Oct 2026 (estimated)
- Primary completion
- 11 Oct 2027 (estimated)
- Study completion
- 11 Oct 2027 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preeclampsia | – | Diagnostic Test: Transthoracic EchocardiographyPeople 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 |
| Healthy Normotensive | – | Diagnostic Test: Transthoracic EchocardiographyHealthy 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 80 pregnant people will be recruited; 40 with preeclampsia, and 40 healthy normotensive pregnant people.
Key inclusion criteria (19 listed)
- 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,
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transthoracic EchocardiographyCardiac output measured by transthoracic echocardiography (TTE) | Diagnostic test | Healthy Normotensive, Preeclampsia |
Primary outcome
Cardiac output measured by transthoracic echocardiography (TTE) at rest: CO mL/min.
Time frame: During gestation (8 wks to 42 wks, during clinic or hospital visits) with diagnosis of Preeclampsia
Cardiac output measured by transthoracic echocardiography (TTE)
1 secondary outcome
cardiac output measured by transthoracic echocardiography (TTE) after treatment with antihypertensive agents, and during CD and postpartum
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Background: PubMed 24986564Dennis 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.
- Results publication: PubMed 25812006Dennis AT. Transthoracic echocardiography in women with preeclampsia. Curr Opin Anaesthesiol. 2015 Jun;28(3):254-60. doi: 10.1097/ACO.0000000000000182.
- Results publication: PubMed 24673113Dennis 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.
- Individual participant dataSharing planned: Undecided. Results may be the genesis of an international collaborative effort
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michaela Farber, MD principal investigator
BWH
Alicia T Dennis, MBBS PhD MPH study director
University of Melbourne, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output measured by transthoracic echocardiography (TTE) at rest: CO mL/min. (time frame: During gestation (8 wks to 42 wks, during clinic or hospital visits) with diagnosis of Preeclampsia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06099275, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.