Evaluation of Hemodynamics in People With Untreated Preeclampsia Using Echocardiography

Overseen By Michaela Farber, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Vasoactive drugs, Thyroxine

Disqualifiers: Diabetes, Hypertension, Tobacco use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Alicia T Dennis, MBBS PhD MPH

Principal Investigator

University of Melbourne, Australia

Michaela Farber, MD

Principal Investigator

BWH

Eligibility Criteria

Inclusion Criteria

Not in labor

You are currently diagnosed with Preeclampsia.

Individuals who have been diagnosed or are suspected of having preeclampsia, including those with severe features as defined by the American College of Obstetrics and Gynecology, will be recruited for this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Cardiac output is measured using transthoracic echocardiography (TTE) in participants with untreated preeclampsia and healthy normotensive pregnant people

8-42 weeks

During clinic or hospital visits

Treatment Observation

Cardiac output is measured by TTE after treatment with antihypertensive agents and during cesarean delivery

<60 min

During clinic or hospital visits

Postpartum Observation

Cardiac output is measured by TTE immediately after delivery up to 6 hours postpartum

<6 hours

Immediately after delivery

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Participant Groups

Group I: Preeclampsia Experimental Treatment 1 Intervention

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

Group II: Healthy Normotensive Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Fulbright Foundation Scholar in Residence Program

Collaborator

Trials

1

Recruited

80+