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N/A N=186

Thoracic Ultrasonography for Pulmonary Edema in Patients With Pre-Eclampsia

Pre-eclampsia

Enrolled (actual)
186
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Detection of Fluid in the Lungs — 2; 3 Participants — p=.162

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Ultrasound (Device)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Antonios Likourezos
Primary completion
Jan 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Detection of Fluid in the Lungs
2; 3 .162

Summary

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.

Eligibility 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

  • Other cardiovascular or pulmonary problems
  • Other obstetrical or uteroplacental problems - abruption placenta, coagulopathy, immunological disorders.
  • Patients who are in labor or are received induction medications such as Pitocin.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02357264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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