Status:
SUSPENDED
Evaluation of Hemodynamics in People With Untreated Preeclampsia Using Echocardiography
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Fulbright Foundation Scholar in Residence Program
Conditions:
Preeclampsia
Eligibility:
FEMALE
18-55 years
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 healt...
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 t...
Eligibility Criteria
Inclusion
- 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
- No uterine abnormalities
- No placentation abnormalities.
- Not receiving any vasoactive medication including salbutamol
- Not on thyroid replacement hormones
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
October 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 11 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06099275
Start Date
October 25 2023
End Date
October 11 2025
Last Update
October 16 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115