Clinical trial NCT07018362: Ultrasound Assessment of Fetal Growth Parameters
Official title: Research on the Application of Ultrasonography in Fetal Growth Parameters
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Fetal Clavicle Length
Fetal Scapular Width
Fetal Sternal Length
Fetal Scapular Length
Perinatal Outcomes of the Mother and Fetus
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women with singleton pregnancies at 12 to 40 weeks of gestation

Brief summary: The goal of this observational study is to establish reference value ranges for normal fetal biometric parameters at different gestational weeks for the domestic population, and evaluate their clinical application to predict perinatal outcomes. The main question it aims to answer is:

What is the relationship between fetal parameter measurements (such as clavicle length, scapular width, scapular length, sternum length, and cranial structure measurements) and gestational age as well as other growth parameters?

And how can these parameters be used in clinical applications such as predicting perinatal outcomes?

Researchers will observe the relationship between the measurement values of fetal clavicle length, scapular width, scapular length, sternum length, and cranial structure and gestational age as well as other growth parameters, and ultimately follow up on the perinatal outcomes of mother and fetus.


Eligibility criteria: Inclusion Criteria:

Singleton pregnancy; The date of the last menstrual period was determined for each pregnant woman, and a history of regular menstrual cycles was confirmed; Pregnant women had no maternal diseases that could affect fetal growth and development, such as diabetes, pregnancy-induced hypertension, or chronic infections; Fetuses had no chromosomal or structural abnormalities; Gestational age (calculated based on the last menstrual period) was within 7 days of the ultrasound biometric measurements; Good image quality.

Exclusion Criteria:

Multiple gestation, fetal demise, or stillbirth; Pregnancy complications or comorbidities affecting fetal growth; Clinically diagnosed fetal growth restriction (FGR); Confirmed pathogenic infections (serology-positive), including TORCH, HIV, RPR, or other infections; Prenatal ultrasound indicating fetal hydrops, structural anomalies, or chromosomal abnormalities; History of substance abuse (e.g., drugs, smoking, alcohol) or medication use in early pregnancy; Discrepancy between clinical gestational age and ultrasound-estimated gestational age; Lack of follow-up information.

Primary outcomes:
measure: fetal clavicle length
timeFrame: gestational weeks 12 to 40
measure: scapular width and scapular length
timeFrame: gestational weeks 12 to 40
measure: sternal length
timeFrame: gestational weeks 12 to 40
Secondary outcomes:
Other outcomes:
Locations:
city: Xiamen
country: China
facility: EPIQ 7 (Philips Healthcare, Bothell, WA) 和 Voluson E10 (GE Healthcare, Milwaukee, WI)
state: Fujian
Study officials:
References: