Evaluation of Hemodynamics in People With Untreated Preeclampsia Using Echocardiography

Last updated: February 20, 2024
Sponsor: Brigham and Women's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Preeclampsia

Pregnancy Complications

Treatment

Transthoracic Echocardiography

Clinical Study ID

NCT06099275
2023P002364
  • Ages 18-55
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Preeclampsia Participant.

  1. Preclampsia definition: People with preeclampsia will be recruited at the time ofdiagnosis or suspected diagnosis of preeclampsia, according to accepted definitions ofpreeclampsia. Preeclampsia with severe features will be defined using the AmericanCollege 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 adhesivedisorder,
  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
  9. American Society of Anesthesiologists (ASA) Classification II with no significantmedical or surgical illness,
  10. Nulliparous (first pregnancy beyond 20 week's gestation)
  11. Non-smokers, singleton pregnancy
  12. Not having ruptured membranes
  13. No uterine abnormalities
  14. No placentation abnormalities.
  15. Not receiving any vasoactive medication including salbutamol
  16. Not on thyroid replacement hormones

Exclusion

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:
  9. Current administration of vasoactive drugs including salbutamol
  10. Current administration of thyroxine
  11. Pre-existing or gestational diabetes
  12. Tobacco use
  13. Pre-existing or gestational hypertension or preeclampsia
  14. Known uterine abnormality, in labor or ruptured membranes
  15. Unable to tolerate a 30-minute ultrasound examination (TTE)
  16. Age less than 18 or greater than 50 years
  17. BMI > 40 kg/m2,
  18. Gestation < 20 weeks.

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Transthoracic Echocardiography
Phase:
Study Start date:
October 25, 2023
Estimated Completion Date:
October 11, 2025

Study 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.

Connect with a study center

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

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