Fetal Clavicle LengthNCT07018362
Ultrasound Assessment of Fetal Growth Parameters
An observational study of Fetal Clavicle Length and Fetal Scapular Width, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Clavicle Length, Fetal Scapular Width, Fetal Sternal Length
- What is being tested?
- restricted fetal growth
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 30 Nov 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women with singleton pregnancies at 12 to 40 weeks of gestation
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
EPIQ 7 (Philips Healthcare, Bothell, WA) 和 Voluson E10 (GE Healthcare, Milwaukee, WI)
Xiamen, Fujian, 361003
About this study
Official title: Research on the Application of Ultrasonography in Fetal Growth Parameters
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?
Read more
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
- Being tested
- restricted fetal growth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
restricted fetal growthOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
fetal clavicle length
By sliding the probe at the fetal thoracic inlet, the clavicle can be visualized. Continuously adjust the probe orientation during scanning to ensure the clavicle is displayed at its maximum length. Place the electronic calipers at the midpoint of the sternal end and the acromial end of the clavicle, respectively. The measured distance represents the clavicular length, expressed in centimeters (cm).
Measured: gestational weeks 12 to 40
scapular width and scapular length
Identify the fetal spine in the longitudinal plane. Align the probe parallel to this plane and move it laterally, continuously adjusting and slightly rotating the probe until the acoustic window simultaneously displays both the acromion and inferior angle of the scapula. The maximum distance between these two landmarks represents the scapular length.
For scapular width measurement: Based on the scapular length view, further rotate the probe centered on the acromion to approximate a transverse fetal plane until the scapular spine is fully visualized at its maximal length. The longest distance between the acromion and medial border of the scapular spine is defined as the scapular width. All measurements are expressed in centimeters (cm).
Measured: gestational weeks 12 to 40
sternal length
On the coronal or sagittal plane of the fetal chest region, continuously adjust the probe until the full length of the fetal sternum is visualized. Place the electronic calipers at the cephalic end of the first ossification center and the caudal end of the last ossification center, respectively. The measured distance represents the sternal length, expressed in centimeters (cm).
Measured: gestational weeks 12 to 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Jul 2025
- Primary completion1 Jan 2032 (estimated)
- Study completion30 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Clavicle LengthStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YiMing Su, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018362
- Sponsor's protocol ID
- FirstAHXiamenUsym
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Application of Ultrasonography in Fetal Growth Parameters
- ClinicalTrials.gov ID
- NCT07018362
- Acronym / sponsor ID
- FirstAHXiamenUsym
- Conditions
- Fetal Clavicle Length, Fetal Scapular Width, Fetal Sternal Length, Fetal Scapular Length, Perinatal Outcomes of the Mother and Fetus
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jan 2032 (estimated)
- Study completion
- 30 Nov 2032 (estimated)
- First posted
- 12 Jun 2025 (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 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women with singleton pregnancies at 12 to 40 weeks of gestation
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| restricted fetal growthThe 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. | Other | – |
Primary outcome
fetal clavicle length
Time frame: gestational weeks 12 to 40
By sliding the probe at the fetal thoracic inlet, the clavicle can be visualized. Continuously adjust the probe orientation during scanning to ensure the clavicle is displayed at its maximum length. Place the electronic calipers at the midpoint of the sternal end and the acromial end of the clavicle, respectively. The measured distance represents the clavicular length, expressed in centimeters (cm).
scapular width and scapular length
Time frame: gestational weeks 12 to 40
Identify the fetal spine in the longitudinal plane. Align the probe parallel to this plane and move it laterally, continuously adjusting and slightly rotating the probe until the acoustic window simultaneously displays both the acromion and inferior angle of the scapula. The maximum distance between these two landmarks represents the scapular length. For scapular width measurement: Based on the scapular length view, further rotate the probe centered on the acromion to approximate a transverse fetal plane until the scapular spine is fully visualized at its maximal length. The longest distance between the acromion and medial border of the scapular spine is defined as the scapular width. All measurements are expressed in centimeters (cm).
sternal length
Time frame: gestational weeks 12 to 40
On the coronal or sagittal plane of the fetal chest region, continuously adjust the probe until the full length of the fetal sternum is visualized. Place the electronic calipers at the cephalic end of the first ossification center and the caudal end of the last ossification center, respectively. The measured distance represents the sternal length, expressed in centimeters (cm).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fetal Clavicle Length and Fetal Scapular Width, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 5 Aug 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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 clavicle length (time frame: gestational weeks 12 to 40). The study lists 3 primary outcomes in all. 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 5 Aug 2025.