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

NCT06168149 | Completed

• 1 other identifier: AEŞH-EK1-2023-516
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Labor; Respiratory Distress Syndrome

Keywords

Preterm Labor; Respiratory Distress Syndrome; Fetal Lung Elastography; Elastography

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

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.

Diagnostic Test: fetal lung elastography measurement

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.

Diagnostic Test: fetal lung elastography measurement

Interventions

fetal lung elastography measurement DIAGNOSTIC_TEST

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; Neonates with respiratory distress syndrome

Eligibility Criteria

• Age: 24 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study will include single pregnant women with maternal age of 18-45 years, gestational age between 24-34 weeks, diagnosed with preterm labor, amniotic fluid pathology, fetal congenital and chromosomal anomalies, and fetuses without fetal congenital and chromosomal anomalies, who were hospitalized in the ward after the application to the Perinatology Clinic of Etlik City Hospital. A total of 80 patients without systemic maternal disease findings and diagnoses, without chronic drug use, who were measured at least 24 hours after antenatal corticosteroids were administered and delivered 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Etlik City Hospital

Ankara, Yenimahalle, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obstetric Labor, Premature; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Ahmet Kurt, 1

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician- Obstetric and Gynecology Department

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: December 13, 2023
• Study Start: September 6, 2023
• Primary Completion: May 15, 2024
• Study Completion: September 6, 2024
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)