Evaluating heart function in pregnant individuals with untreated preeclampsia

Evaluation of Hemodynamics in People With Untreated Preeclampsia Using Echocardiography

This study is testing how heart function is affected in pregnant people with untreated preeclampsia compared to healthy pregnant individuals, to help improve care for this condition.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years to 55 Years
• Sex: Female
• Sponsor: Brigham and Women's Hospital (other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT06099275 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess resting cardiac output in individuals diagnosed with untreated preeclampsia using transthoracic echocardiography (TTE). The research will compare these findings with a cohort of healthy normotensive pregnant individuals to enhance understanding of the condition's pathophysiology. Additionally, the study will investigate changes in cardiac output during cesarean delivery and after treatment with antihypertensive agents. The goal is to integrate echocardiography into the management of preeclampsia and evaluate its feasibility in a multidisciplinary setting at Brigham and Women's Hospital in Boston.

Who should consider this trial

Good fit: Ideal candidates include pregnant individuals diagnosed with preeclampsia who meet specific inclusion criteria.

Not a fit: Patients with preexisting cardiovascular, hepatic, or respiratory issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management and treatment strategies for patients with preeclampsia.

How similar studies have performed: While the approach of using echocardiography in this context is innovative, similar studies have shown promise in understanding cardiac function in pregnancy-related conditions.

Eligibility criteria

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.

Where this trial is running

Boston, Massachusetts

• Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Michaela Farber, MD — BWH
• Study coordinator: Michaela Farber, MD

Conditions: Preeclampsia, Transthoracic Echocardiography, Antihypertensive Agents, Pregnancy