Thoracic Ultrasonography for Pulmonary Edema in Patients With Pre-Eclampsia

NCT02357264 | Completed Results

• 1 other identifier: 2014-11-25
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pre-eclampsia

Outcome Measures

Primary Outcomes (1)

• Detection of Fluid in the Lungs

  Detection of Fluid in the lungs in patients with pre-eclampsia vs. pregnant patients without pre-eclampsia

  24-36 weeks

Study Arms (2)

pre-eclampsia

Ultrasound of Pregnant Females 18+ with pre-Eclampsia

Device: Ultrasound

No pre-eclampsia.

Ultrasound of Pregnant Females 18+ with no pre-eclampsia

Device: Ultrasound

Interventions

Ultrasound DEVICE

Ultrasound of the chest for the detection of fluid in the lung

No pre-eclampsia.; pre-eclampsia

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant Females

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (8)

• Hutcheon JA, Lisonkova S, Joseph KS. Epidemiology of pre-eclampsia and the other hypertensive disorders of pregnancy. Best Pract Res Clin Obstet Gynaecol. 2011 Aug;25(4):391-403. doi: 10.1016/j.bpobgyn.2011.01.006. Epub 2011 Feb 18.

  PMID: 21333604 BACKGROUND

• Dennis AT, Solnordal CB. Acute pulmonary oedema in pregnant women. Anaesthesia. 2012 Jun;67(6):646-59. doi: 10.1111/j.1365-2044.2012.07055.x. Epub 2012 Mar 15.

  PMID: 22420683 BACKGROUND

• Sciscione AC, Ivester T, Largoza M, Manley J, Shlossman P, Colmorgen GH. Acute pulmonary edema in pregnancy. Obstet Gynecol. 2003 Mar;101(3):511-5. doi: 10.1016/s0029-7844(02)02733-3.

  PMID: 12636955 BACKGROUND

• Bamfo JE, Kametas NA, Nicolaides KH, Chambers JB. Maternal left ventricular diastolic and systolic long-axis function during normal pregnancy. Eur J Echocardiogr. 2007 Oct;8(5):360-8. doi: 10.1016/j.euje.2006.12.004. Epub 2007 Feb 23.

  PMID: 17321800 BACKGROUND

• Young P, Johanson R. Haemodynamic, invasive and echocardiographic monitoring in the hypertensive parturient. Best Pract Res Clin Obstet Gynaecol. 2001 Aug;15(4):605-22. doi: 10.1053/beog.2001.0203.

  PMID: 11478818 BACKGROUND

• Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.

  PMID: 22392031 BACKGROUND

• Lichtenstein D, Goldstein I, Mourgeon E, Cluzel P, Grenier P, Rouby JJ. Comparative diagnostic performances of auscultation, chest radiography, and lung ultrasonography in acute respiratory distress syndrome. Anesthesiology. 2004 Jan;100(1):9-15. doi: 10.1097/00000542-200401000-00006.

  PMID: 14695718 BACKGROUND

• Lichtenstein D, Meziere G, Biderman P, Gepner A, Barre O. The comet-tail artifact. An ultrasound sign of alveolar-interstitial syndrome. Am J Respir Crit Care Med. 1997 Nov;156(5):1640-6. doi: 10.1164/ajrccm.156.5.96-07096.

  PMID: 9372688 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Eitan Dickman, MD
• Organization: Maimonides Medical Center

edickman@maimonidesmed.org

718-283-6057

Study Officials

• Eitan Dickman, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: January 31, 2015
• First Posted: February 6, 2015
• Study Start: February 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: May 15, 2017
• Results First Posted: May 15, 2017

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)