The Relationship of Fetal Lung Elastography Values With the Development of Respiratory Distress in Cases of Preterm Labor
NCT ID: NCT06168149
Last Updated: 2023-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
80 participants
OBSERVATIONAL
2023-09-06
2024-03-06
Brief Summary
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Detailed Description
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The advantages of FAE are:
It is a non-invasive method: FAE is performed using ultrasound technology and has no known maternal or fetal harm. It stands as a potentially safe method compared to current invasive tests.
It is cost-effective and easy to perform: FAE is a procedure performed using existing ultrasound equipment at no separate cost. Therefore, it can be easily implemented and repeated in clinical settings.
Fast results: FAE provides fast results by acquiring images in real time. This indicates that FAE can be a valuable diagnostic tool in emergency situations or when rapid decision-making is required.
A potential predictive tool: The results of this study may indicate that FAE values are a potential tool for predicting the risk of developing RDS. This could be an important step to develop early diagnosis and treatment strategies to improve the respiratory health of preterm newborns.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Neonates with respiratory distress syndrome
A total of 80 patients with no systemic maternal disease findings and diagnoses, without chronic drug use, who were measured at least 24 hours after antenatal corticosteroids were administered during pregnancy, and whose delivery occurred within a maximum of 72 hours, will be included in our study as two case groups with and without RDS diagnosis in neonatal follow-up.
fetal lung elastography measurement
Elastography measurements are planned to be performed as in the studies "Feasibility of two-dimensional ultrasound shear wave elastography of human fetal lungs and liver: A pilot study" and "Feasibility of 2-D ultrasound shear wave elastography of fetal lungs in case of threatened preterm labour: a study protocol" in the literature examples section of the file.
Neonates who do not develop respiratory distress syndrome
A total of 80 patients with no systemic maternal disease findings and diagnoses, without chronic drug use, who were measured at least 24 hours after antenatal corticosteroids were administered during pregnancy, and whose delivery occurred within a maximum of 72 hours, will be included in our study as two case groups with and without RDS diagnosis in neonatal follow-up.
fetal lung elastography measurement
Elastography measurements are planned to be performed as in the studies "Feasibility of two-dimensional ultrasound shear wave elastography of human fetal lungs and liver: A pilot study" and "Feasibility of 2-D ultrasound shear wave elastography of fetal lungs in case of threatened preterm labour: a study protocol" in the literature examples section of the file.
Interventions
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fetal lung elastography measurement
Elastography measurements are planned to be performed as in the studies "Feasibility of two-dimensional ultrasound shear wave elastography of human fetal lungs and liver: A pilot study" and "Feasibility of 2-D ultrasound shear wave elastography of fetal lungs in case of threatened preterm labour: a study protocol" in the literature examples section of the file.
Eligibility Criteria
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Inclusion Criteria
* Single pregnant women who were followed up with a diagnosis of preterm labor between 24-33 weeks and who volunteered and consented to the study
* Measured at least 24 hours after antenatal corticosteroid and delivered within a maximum of 72 hours after measurement
Exclusion Criteria
* Amniotic fluid pathologies
* Fetal lung and liver diseases
* Fetal genetic and structural anomalies
* Signs and diagnoses of systemic maternal diseases
* Advanced maternal obesity preventing measurement
* Patients hospitalized with a diagnosis of preterm labor and discharged before delivery
* Presence of comorbid diseases of pregnancy (GDM, hypertensive diseases of pregnancy, PPROM, chorioamnionitis etc.)
* Pregnant women over 45 years of age, systemic conditions (history of chronic, mental, physical illness, severe renal, hepatic, gastrointestinal acute/chronic inflammatory disease, hyperthyroidism, hypothyroidism, hypertension, type 1/2 DM, history of malignancy, smoking, alcohol use)
24 Weeks
34 Weeks
ALL
Yes
Sponsors
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Ankara Etlik City Hospital
OTHER_GOV
Responsible Party
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Ahmet Kurt
Resident Physician- Obstetric and Gynecology Department
Principal Investigators
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Ahmet Kurt, 1
Role: PRINCIPAL_INVESTIGATOR
Ankara Etlik City Hospital
Locations
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Etlik City Hospital
Ankara, Yenimahalle, Turkey (Türkiye)
Countries
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Other Identifiers
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AEŞH-EK1-2023-516
Identifier Type: -
Identifier Source: org_study_id