NCT03576092

Brief Summary

Evaluation of lung ultrasound as a diagnostic tool in pregnant patients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 3, 2018

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

1.8 years

First QC Date

May 29, 2018

Last Update Submit

May 30, 2023

Conditions

Pregnancy ComplicationsUltrasound Therapy; ComplicationsPulmonary DiseasePulmonary Edema

Outcome Measures

Primary Outcomes (1)

  • Positive Lung Ultrasound Study

    ultrasound finding of three or more B-lines in an interstitial space in two or more lung regions.

    At time of lung ultrasound study, through study completion from August 2016 - May 2018.

Study Arms (2)

Normal Pregnancy

Healthy gestational age-matched pregnant patients from 32 - 41 weeks without a diagnosis of preeclampsia.

Diagnostic Test: Lung Ultrasound

Preeclampsia Pregnancy

Pregnant patients from 32 - 41 weeks with a diagnosis of preeclampsia based on standard criteria as outlined by the American Congress of Obstetrics and Gynecology (ACOG).

Diagnostic Test: Lung Ultrasound

Interventions

Lung UltrasoundDIAGNOSTIC_TEST

Lung sonography will be performed on a SonoSite portable ultrasound machine with a C60e 5 - 2 MHx 30cm probe using a modified standard technique examining four lung regions; anterior mid-clavicular high and low on left and right sides, and one on each side posteriorly) in the semi-recumbent position.

Normal PregnancyPreeclampsia Pregnancy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The subject population is 262 pregnant female participants between ages 18 to approximately 49 years old. Pregnant patients must be used in the study population because the objective is to evaluate lung ultrasound as a tool in the pregnant population.

You may qualify if:

  • ≥ 18 years old
  • Singleton pregnancy
  • /7 weeks - 41 6/7 weeks gestational age

You may not qualify if:

  • Inability to provide informed consent
  • Refusal to participate
  • Already treated for acute lung pathology prior to enrollment
  • Cognitive impairment that precluded understanding of research procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Blanco PA, Cianciulli TF. Pulmonary Edema Assessed by Ultrasound: Impact in Cardiology and Intensive Care Practice. Echocardiography. 2016 May;33(5):778-87. doi: 10.1111/echo.13182. Epub 2016 Feb 3.

    PMID: 26841270BACKGROUND

  • Pachtman S, Koenig S, Meirowitz N. Detecting Pulmonary Edema in Obstetric Patients Through Point-of-Care Lung Ultrasonography. Obstet Gynecol. 2017 Mar;129(3):525-529. doi: 10.1097/AOG.0000000000001909.

    PMID: 28178063BACKGROUND

  • 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: 22420683BACKGROUND

  • Inchingolo R, Smargiassi A, Mormile F, Marra R, De Carolis S, Lanzone A, Valente S, Corbo GM. Look at the lung: can chest ultrasonography be useful in pregnancy? Multidiscip Respir Med. 2014 Jun 6;9(1):32. doi: 10.1186/2049-6958-9-32. eCollection 2014.

    PMID: 24936303BACKGROUND

  • Malek G, Drygalska A, Kober J, Wawrzynska L, Debski R, Dabrowski M, Torbicki A. [Chest ultrasound in the diagnosis of pulmonary embolism in a pregnant patient - a case report]. Pneumonol Alergol Pol. 2009;77(6):560-4. Polish.

    PMID: 20013708BACKGROUND

  • Samol JM, Lambers DS. Magnesium sulfate tocolysis and pulmonary edema: the drug or the vehicle? Am J Obstet Gynecol. 2005 May;192(5):1430-2. doi: 10.1016/j.ajog.2005.02.093.

    PMID: 15902128BACKGROUND

  • Sibai BM, Mabie BC, Harvey CJ, Gonzalez AR. Pulmonary edema in severe preeclampsia-eclampsia: analysis of thirty-seven consecutive cases. Am J Obstet Gynecol. 1987 May;156(5):1174-9. doi: 10.1016/0002-9378(87)90135-9.

    PMID: 3578433BACKGROUND

  • Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. doi: 10.1016/j.ajem.2006.02.013.

    PMID: 16984837BACKGROUND

MeSH Terms

Conditions

Pregnancy ComplicationsLung DiseasesPulmonary Edema

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2018

First Posted

July 3, 2018

Study Start

August 15, 2016

Primary Completion

May 20, 2018

Study Completion

May 20, 2018

Last Updated

June 1, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share