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

Respiratory Distress Syndrome Clinical Trial

Official title:

Preterm Eylem Olgularında; Fetal Akciğer Elastografi Değerlerinin Respiratuvar Distres Gelişimi Ile İlişkisi

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06168149
• Other study ID #: AESH-EK1-2023-516
• Status: Active, not recruiting
• Start date: September 6, 2023
• Est. completion date: March 6, 2024

Study information

• Verified date: December 2023
• Source: Ankara Etlik City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: March 6, 2024
• Est. primary completion date: March 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Weeks to 34 Weeks

Eligibility

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)

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Turkey	Etlik City Hospital	Ankara	Yenimahalle

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Etlik City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal Lung Elastography Measurement	Measurement of prenatal ultrasonographic shear wave elastographic values(kPa) of the fetus in cases of preterm labor	Prenatal (24-34 gestational weeks, before 72 hours to delivery)