Preterm LaborNCT06168149
The Relationship of Fetal Lung Elastography Values With the Development of Respiratory Distress in Cases of Preterm Labor
An observational study of Preterm Labor and Respiratory Distress Syndrome, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 24 to 34 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor, Respiratory Distress Syndrome
- What is being tested?
- fetal lung elastography measurement
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Sep 2023to 6 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 34 weeks
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Etlik City Hospital
Ankara, Yenimahalle, 06000
About this study
Official title: Preterm Eylem Olgularında; Fetal Akciğer Elastografi Değerlerinin Respiratuvar Distres Gelişimi Ile İlişkisi
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.
- Conditions
- Preterm Labor, Respiratory Distress Syndrome
- Being tested
- fetal lung elastography measurement
- Keywords
- Preterm Labor, Respiratory Distress Syndrome, Fetal Lung Elastography, Elastography
- Medical subject headings
- Obstetric Labor, Premature, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fetal lung elastography measurementDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: fetal lung elastography measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal Lung Elastography Measurement
Measurement of prenatal ultrasonographic shear wave elastographic values(kPa) of the fetus in cases of preterm labor
Measured: Prenatal (24-34 gestational weeks, before 72 hours to delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start6 Sep 2023
- Primary completion15 May 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmet Kurt, Ankara Etlik City Hospital
- Investigators
- Ahmet Kurt, 1, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168149
- Sponsor's protocol ID
- AEŞH-EK1-2023-516
- Status last verified
- Mar 2026
- First submitted
- 17 Nov 2023
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data is not open to sharing due to hospital policy. however, if necessary, the principal investigator can be reached via e-mail.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preterm Eylem Olgularında; Fetal Akciğer Elastografi Değerlerinin Respiratuvar Distres Gelişimi Ile İlişkisi
- ClinicalTrials.gov ID
- NCT06168149
- Acronym / sponsor ID
- AEŞH-EK1-2023-516
- Conditions
- Preterm Labor, Respiratory Distress Syndrome
- Keywords
- Preterm Labor, Respiratory Distress Syndrome, Fetal Lung Elastography, Elastography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neonates with respiratory distress syndrome | – | Diagnostic Test: fetal lung elastography measurementA 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. |
| Neonates who do not develop respiratory distress syndrome | – | Diagnostic Test: fetal lung elastography measurementA 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. |
Who may qualify
- Ages
- 24 to 34 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- Multiple pregnancies
- Amniotic fluid pathologies
- Fetal lung and liver diseases
- Fetal genetic and structural anomalies
- Signs and diagnoses of systemic maternal diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fetal lung elastography measurementElastography 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. | Diagnostic test | Neonates who do not develop respiratory distress syndrome, Neonates with respiratory distress syndrome |
Primary outcome
Fetal Lung Elastography Measurement
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No. Patient data is not open to sharing due to hospital policy. however, if necessary, the principal investigator can be reached via e-mail.
Related trials for Preterm Labor
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The Periviable GOALS Decision Support Tool
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Kurt, 1 principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Labor and Respiratory Distress Syndrome, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal Lung Elastography Measurement (time frame: Prenatal (24-34 gestational weeks, before 72 hours to delivery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.