NCT05487014

Brief Summary

A total of eight quadrants of standard lung US examination was performed to all pregnant women with preeclampsia within the scope of the study by the same anesthesiologist, dividing each hemithorax into four regions through the parasternal, anterior axillary, posterior axillary vertical lines, and the horizontal line assumed to pass under the nipple. The resulting images were stored in digital media. A Lung US examination was performed once for an average of 5-10 minutes. The presence of B lines was investigated in the examination. The case was defined as interstitial edema when the B lines, which are defined as vertical linear hyperechoic reverberation artifacts representing the edematous interlobular septa/alveoli, extend posteriorly from below the pleural line and moving in sync with lung movements, are found in two or more lung areas. B-lines were determined for each case and reported in standard form in terms of number and morphology. The diagnostic accuracy of B lines was determined with the artificial intelligence supported SmartAlpha Rievi 1300 software program. B-lines validated by artificial intelligence assisted algorithm in all stored digital images were reported blindly by another anesthesiologist experienced in lung US. The clinical features, laboratory parameters, and intraoperative hemodynamic data of the cases were recorded to be evaluated in terms of relationship with lung US data. We predict that the application of lung US with artificial intelligence software will provide an opportunity to quickly evaluate the clinic of preeclamptic pregnant women who are frequently operated on in emergency conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

August 2, 2022

Last Update Submit

August 8, 2022

Conditions

Keywords

preeclampsialung ultrasoundartificial intelligence

Outcome Measures

Primary Outcomes (1)

  • For comparison, artificial intelligence assisted ultrasound and standard ultrasound in the follow-up of 35 preeclamptic parturients will be performed.

    If present, pulmonary edema will be diagnosed by visualising 3 B lines at least 2 or more regions

    Lung ultrasound application once in the preoperative period

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

35 parturients who diagnosed with preeclampsia

You may qualify if:

  • Pregnant women who underwent cesarean section with a diagnosis of preeclampsia

You may not qualify if:

  • Preeclamptic parturients who have another lung disease
  • Preeclamptic parturients whose optimal lung US image could not be obtained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selin Bağcaz

Çankaya, Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pre-EclampsiaPulmonary Edema

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesLung DiseasesRespiratory Tract Diseases

Study Officials

  • D.Berrin Gunaydin, Prof.

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor doctor

Study Record Dates

First Submitted

August 2, 2022

First Posted

August 4, 2022

Study Start

July 1, 2021

Primary Completion

July 1, 2022

Study Completion

July 26, 2022

Last Updated

August 10, 2022

Record last verified: 2022-08

Locations