RECRUITING

Evaluation of Hemodynamics in People With Untreated Preeclampsia Using Echocardiography

Conditions

Preeclampsia Transthoracic Echocardiography Antihypertensive Agents Pregnancy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluation of Hemodynamics in People With Untreated Preeclampsia Using Echocardiography

Quick Facts

Study Start:2023-10-25

Study Completion:2025-10-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06099275

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
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. 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	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. 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.

Inclusion Criteria

Exclusion Criteria

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.
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

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.
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.

Contacts and Locations

Study Contact

Michaela Farber, MD

CONTACT

6177328216

mfarber@bwh.harvard.edu

Principal Investigator

Michaela Farber, MD

PRINCIPAL_INVESTIGATOR

BWH

Alicia T Dennis, MBBS PhD MPH

STUDY_DIRECTOR

University of Melbourne, Australia

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Michaela Farber, MD, PRINCIPAL_INVESTIGATOR, BWH
Alicia T Dennis, MBBS PhD MPH, STUDY_DIRECTOR, University of Melbourne, Australia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-25

Study Completion Date2025-10-11

Study Record Updates

Study Start Date2023-10-25

Study Completion Date2025-10-11

Terms related to this study

Keywords Provided by Researchers

Preeclampsia
Transthoracic Echocardiography
Antihypertensive Agents
Pregnancy

Additional Relevant MeSH Terms

Preeclampsia