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Assessment of fetal lung maturity by two-dimensional shear wave elastography and its clinical application

Assessment of fetal lung maturity by two-dimensional shear wave elastography and its pathological characteristics

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300077320
Enrollment
Unknown
Registered
2023-11-06
Start date
2022-09-11
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital heart disease, CHD

Interventions

Normal group:None
Congenital heart disease group:None
Follow up group:None
Pathology group:None

Sponsors

Second Affiliated Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 41 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for the follow-up group: ? 20-24 gestational weeks of singleton pregnancy; ? Regular and normal menstruation in ordinary life, early pregnancy ultrasound measurements consistent with the gestational week; ? Routine prenatal ultrasound screening for malformations did not reveal any abnormality; ? The pregnant woman agrees to have monthly follow-up examinations on the specified dates; ? Normal newborn follow-up. Inclusion criteria for congenital heart disease group: ? 20-40 gestational weeks of singleton pregnancy; ? Regular and normal menstruation in ordinary life, early pregnancy ultrasound measurements consistent with the gestational week; ? Routine prenatal ultrasound screening for malformations did not reveal any abnormality other than congenital heart disease; ? The fetus was diagnosed with congenital heart disease in our hospital. Inclusion criteria of normal group: ? 20-40 gestational weeks of singleton pregnancy; ? Regular and normal menstruation, early pregnancy ultrasound measurements consistent with the gestational week; ? Routine prenatal ultrasound screening for malformations did not find any abnormality; Pathology group inclusion criteria: ? Pregnant women whose gestational age is within 16~28 weeks who decide to induce labor for various reasons; ? Pregnant women who decide to induce labor within 28~40 weeks of gestational age with a certificate of induction of labor.

Exclusion criteria

Exclusion criteria: Follow-up group discharge criteria: ? Twin or multiple pregnancies; ? Pregnant women suffering from gestational diabetes, hyperemesis gravidarum and other systemic diseases; ? Diseases affecting fetal growth and development such as intrauterine growth restriction or preterm labor; ? The fetus has pathological changes in lungs or liver; ? The presence of fetal malformation in prenatal ultrasound examination; ? Failure to complete regular follow-up visits due to various reasons. Exclusion criteria for congenital heart disease group: ? twin or multiple births. ? Twin or multiple pregnancies; ? Pregnant women with systemic diseases such as systemic lupus erythematosus, gestational diabetes mellitus, gestational hypertension and other systemic diseases; ? Diseases affecting the growth and development of the fetus such as placental abruption, preterm labor, intrauterine growth retardation; ? Presence of pathological changes in the lungs or liver of the fetus; ? Presence of malformations other than congenital heart disease in the fetus by prenatal ultrasonography. Normal group discharge criteria: ? Twin or multiple pregnancies; ? Pregnant women with gestational diabetes, systemic lupus erythematosus, hyperemesis gravidarum and other systemic diseases; ? Suffering from intrauterine growth restriction, placental abruption, preterm labor and other diseases that affect fetal growth and development; ? Presence of pathological changes in the lungs or liver of the fetus; ? The presence of fetal malformation in prenatal ultrasound examination. Pathologic group discharge criteria: ? Pregnant women whose gestational age is within 28~40 but without certificate of induced labor; ? The patient does not agree to perform lung tissue autopsy on the induced abortion fetus; ? Pregnant women who did not undergo shear wave elastography within 3 days before induction of labor.

Design outcomes

Primary

MeasureTime frame
Fetal lung elasticity value;Fetal liver elasticity value;

Secondary

MeasureTime frame
Measuring depth;Reliability index;

Countries

China

Contacts

Public ContactLiya Li

Second Affiliated Hospital of Fujian Medical University

lgr_feus@sina.com+86 189 6552 5702

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026