The Relationship of Fetal Lung Elastography Values With the Development of Respiratory Distress in Cases of Preterm Labor

Active, not recruiting

• Conditions: Preterm Labor; Respiratory Distress Syndrome

• Registration Number: NCT06168149
• Lead Sponsor: Ankara Etlik City Hospital

Brief Summary

The aim of this study was to compare fetal lung elastography (FAE) values between groups with and without Respiratory Distress Syndrome (RDS) in preterm neonates and to evaluate the potential of FAE to predict the risk of developing RDS.

Detailed Description

The evaluate the potential of fetal lung elastography as a non-invasive method to predict and treatment respiratory complications in preterm neonates. FAE is an imaging method that measures the elasticity properties of fetal lung tissue using ultrasound technology. This method can be helpful in providing information about the development and respiratory function of the fetal lungs.

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.

Study Timeline

• Study Start: 2023-09-06
• Study First Submitted: 2023-11-17
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-04
• Last Update Submitted: 2023-12-04
• Study First Posted: 2023-12-13
• Last Update Posted: 2023-12-13
• Primary Completion: 2024-03-06
• Study Completion: 2024-03-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 18-45 years old
• 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

• Multiple pregnancies
• 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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fetal Lung Elastography Measurement	Prenatal (24-34 gestational weeks, before 72 hours to delivery)	Measurement of prenatal ultrasonographic shear wave elastographic values(kPa) of the fetus in cases of preterm labor

Trial Locations

Locations (1)

Etlik City Hospital; 🇹🇷 Ankara, Yenimahalle, Turkey