Brooklyn, New York 11219


Purpose:

This project will study the use of ultrasound of the chest for the detection of fluid in the lungs in patients with pre-eclampsia vs pregnant patients without pre-eclampsia. Pre-eclampsia is a syndrome usually diagnosed in the second half of pregnancy in which patients develop elevated blood pressure and may develop protein in their urine, neurologic abnormalities, fluid in the lungs, and abnormal blood tests associated with the liver and kidney. Pulmonary edema (fluid in the lungs) in pre-eclampsia can lead to patient discomfort and significant morbidity and mortality. It can be detected using chest x-ray, although this type of imaging offers significant disadvantages, including radiation, which is of particular concern in pregnant patients. In addition, previous studies have demonstrated that chest x-ray is not very accurate in the detection of fluid in the lungs. Multiple previous studies have demonstrated the utility of chest ultrasonography in detecting fluid in the chest, although the vast majority of these studies involved patients with acute decompensated heart failure. Our goal is to evaluate bedside ultrasound of the chest in patients with pre-eclampsia in comparison to normal pregnant patients to determine whether these patients have abnormal fluid in the chest. The investigators will divide our patients into two groups. In the study group, the investigators will include patients with pre-eclampsia with or without shortness of breath, and in the control group, the investigators will include pregnant patients without pre-eclampsia. Informed consent will be obtained from all patients enrolled in the study. These patients will then undergo an ultrasound of the chest, performed by a member of the Emergency Medicine Ultrasound Division. The images will be transmitted wirelessly from the ultrasound machine to a secure web based cloud (Q-path) and will be subsequently reviewed by expert reviewers.


Study summary:

This project will compare the use of ultrasound of the chest for the detection of fluid in the lungs in patients with pre-eclampsia vs pregnant patients without pre-eclampsia. Patients admitted to the obstetrical service will be recruited for study enrollment. We will divide our patients into two groups. In the study group, we will include patients with pre-eclampsia with or without shortness of breath, and in the control group, we will include otherwise healthy pregnant patients. We will exclude patients who are in labor or who are undergoing induction. Informed consent will be obtained from all patients enrolled in the study. Study subjects will then undergo an ultrasound of the chest, performed by a member of the Emergency Medicine Ultrasound Division, who have experience in performing lung ultrasounds. Both hemithoraces will be divided into 4 zones: anterior inferior, anterior superior, lateral inferior, and lateral superior. Each zone will be assessed for the presence of B-lines. For a zone to be considered "positive" for pulmonary edema, there should to be a minimum of 3 B-lines. To diagnose a patient with pulmonary edema, at least two zones in both hemithoraces must be positive. The study investigator will document the presence of B-lines in each particular zone on the data collection sheet. Brief representative video clips will be recorded for each zone. After completing the sonographic examination, the images will be transmitted wirelessly from the ultrasound machine to a secure web based cloud (Q-path) and will be subsequently interpreted by expert reviewers who will be blinded to any clinical information about the patient. They will also document their findings on a separate data collection sheet.


Criteria:

Inclusion Criteria: - Age 18+ years of age - Met criteria for pre-eclampsia as per ACOG guidelines for the study group - Consent to participate in study - Single intrauterine pregnancy Exclusion Criteria: 1. Other cardiovascular or pulmonary problems 2. Other obstetrical or uteroplacental problems - abruption placenta, coagulopathy, immunological disorders. 3. Patients who are in labor or are received induction medications such as Pitocin.


NCT ID:

NCT02357264


Primary Contact:

Principal Investigator
Eitan Dickman, MD
Maimonides Medical Center

Antonios Likourezos, MA, MPH
Phone: 718-283-6896
Email: alikourezos@maimonidesmed.org


Backup Contact:

Email: ipushkar@maimonidesmed.org
Illya Pushkar, MPH
Phone: 718-283-6076


Location Contact:

Brooklyn, New York 11219
United States

Antonios Likourezos, MA, MPH
Phone: 718-283-6896
Email: alikourezos@maimonidesmed.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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