Ultrasound Assessment of Fetal Growth Parameters

NCT ID: NCT07018362

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2032-11-30

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.

Conditions

Fetal Clavicle Length; Fetal Scapular Width; Fetal Sternal Length; Fetal Scapular Length; Perinatal Outcomes of the Mother and Fetus

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Interventions

restricted fetal growth

The fetus is of abnormal size and has not reached its genetic growth potential in utero. Fetal birth weight is less than two standard deviations from the average weight for the same gestational age, or less than the 10th percentile of normal weight for the same age.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role: lead

Responsible Party

YiMing Su

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

EPIQ 7 (Philips Healthcare, Bothell, WA) 和 Voluson E10 (GE Healthcare, Milwaukee, WI)

Xiamen, Fujian, China

Countries

China

Other Identifiers

FirstAHXiamenUsym

Identifier Type: -

Identifier Source: org_study_id