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CompletedNCT06168149Updated Mar 17, 2026

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

An observational study in Preterm Labor and Respiratory Distress Syndrome, sponsored by Ankara Etlik City Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 24 Weeks to 34 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-17.

Sponsored by Ankara Etlik City Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
80
Ages
24 Weeks to 34 Weeks
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Preterm Labor
  • Respiratory Distress Syndrome

Keywords

  • Preterm Labor
  • Respiratory Distress Syndrome
  • Fetal Lung Elastography
  • Elastography
03

In context

Obstetric Labor, Premature

255 studies on the registry are indexed under Obstetric Labor, Premature; 38 are open to participants now.

This study's enrollment of 80 is below the median of 125 across 85 observational studies indexed under Obstetric Labor, Premature.

Browse Obstetric Labor, Premature studies →

Lead sponsor

Ankara Etlik City Hospital is the lead sponsor of 166 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Weeks to 34 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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)
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testfetal 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.

06

What researchers measure

Primary outcomes

  1. Fetal Lung Elastography Measurement

    Measurement of prenatal ultrasonographic shear wave elastographic values(kPa) of the fetus in cases of preterm labor

    Time frame: Prenatal (24-34 gestational weeks, before 72 hours to delivery)

07

Study locations

1 site
  • Etlik City Hospital
    Ankara, Yenimahalle 06000, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — Patient data is not open to sharing due to hospital policy. however, if necessary, the principal investigator can be reached via e-mail.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06168149
Lead sponsor
Ankara Etlik City Hospital
Responsible party
Ahmet Kurt (Resident Physician- Obstetric and Gynecology Department, Ankara Etlik City Hospital) — Principal investigator
First posted
Dec 13, 2023
Start date
Sep 6, 2023
Primary completion
May 15, 2024
Completion
Sep 6, 2024
Last update
Mar 17, 2026

Study contacts

Ahmet Kurt, 1
principal investigator · Ankara Etlik City Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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