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临床试验/NCT06168149
NCT06168149已完成不适用

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

Ankara Etlik City Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年9月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Fetal Lung Elastography Measurement

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
24 Weeks 至 34 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

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.

干预措施: fetal lung elastography measurement (Diagnostic Test)

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.

干预措施: fetal lung elastography measurement (Diagnostic Test)

结局指标

主要结局

Fetal Lung Elastography Measurement

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Ankara Etlik City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ahmet Kurt

Resident Physician- Obstetric and Gynecology Department

Ankara Etlik City Hospital

研究点 (1)

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