Fetal Growth RetardationFMZSCORENCT07004283
Fetal Magnetic Resonance Imaging: Z-score Reference Ranges for a Large Patient Population in Normal Neuroimaging Measurement
An observational study of Fetal Growth Retardation and Fetal Neurodevelopmental Disorder, run by Guangzhou Women and Children's Medical Center at 1 site in China.
Trial summary
This study aims to establish the z score reference ranges of fetal head circumference and other measurement of fetal measurements including biparietal diameter, fronto-occipital diameter, length of the corpus callosum, lateral ventricle, transverse cerebellar diameter, height of the vermis, anteroposterior diameter of… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Growth Retardation, Fetal Neurodevelopmental Disorder
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Dec 2030
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study was based on the Born in Guangzhou Cohort Study (BIGCS), a prospective cohort study conducted in Guangzhou, China. The protocol of BIGCS was described in detail previously [20]. In brief, women who planned to give birth at the Guangzhou Women and Children's Medical Center and live in Guangzhou for at least 3 years after delivery were invited to participate in the BIGCS at their first antenatal visit (< 20 weeks' gestation). The study was approved by the Institutional Ethics Committee of the Guangzhou Women and Children's Medical Center. Before recruitment, written informed consent was obtained from all participants. Inclusion criteria for the current study were (1) pregnant women aged 18 years or above, (2) singleton pregnancies and (3) pre-pregnancy BMI < 18.5 kg/m2. The exclusion criteria were as follows: (1) withdrew before delivery, (2) diagnosed with diabetes, hypertension, and heart disease before pregnancy, (3) terminations of pregnancy or stillbirths, (4) multiple g
Who may be able to join
- The pregnant women in Born in Guangzhou Cohort Study
Who cannot join
- The fetuses with prenatal diagnosis of congenital heart disease or other congenital diseases.
- The fetuses who are high-risk neonates at the delivery.1) preterm infants; (2) infants with extremely low birth weight (ELBW) or who are small for gestational age (SGA);
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to establish the z score reference ranges of fetal head circumference and other measurement of fetal measurements including biparietal diameter, fronto-occipital diameter, length of the corpus callosum, lateral ventricle, transverse cerebellar diameter, height of the vermis, anteroposterior diameter of the vermis，height and width of normal fetuses from 18 to 40 weeks' gestation.
Method-A cohort-based study was conducted on low-risk singleton pregnancies with healthy fetuses. The measurement was performed using simple 2-dimensional MRI on the typical fetal standard view. The reference ranges were constructed according to gestational age (GA), biparietal diameter (BPD), as independent variables based on the best-fit models, both mean and standard deviation (SD).
- Keywords
- z-score, healthy reference range
- Medical subject headings
- Fetal Growth Retardation
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth
Healthy birth
Measured: 20 weeks follow up
Secondary outcomes (1)
low birth weight
Healthy birth
Measured: 20 weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Jan 2024
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RetardationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004283
- Sponsor's protocol ID
- 2025282B00
- Acronym
- FMZSCORE
- Status last verified
- May 2025
- First submitted
- 27 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Magnetic Resonance Imaging: Z-score Reference Ranges for a Large Patient Population in Normal Neuroimaging Measurement
- ClinicalTrials.gov ID
- NCT07004283
- Acronym / sponsor ID
- FMZSCORE / 2025282B00
- Keywords
- z-score, healthy reference range
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 4 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.
This study aims to establish the z score reference ranges of fetal head circumference and other measurement of fetal measurements including biparietal diameter, fronto-occipital diameter, length of the corpus callosum, lateral ventricle, transverse cerebellar diameter, height of the vermis, anteroposterior diameter of the vermis，height and width of normal fetuses from 18 to 40 weeks' gestation.
Method-A cohort-based study was conducted on low-risk singleton pregnancies with healthy fetuses. The measurement was performed using simple 2-dimensional MRI on the typical fetal standard view. The reference ranges were constructed according to gestational age (GA), biparietal diameter (BPD), as independent variables based on the best-fit models, both mean and standard deviation (SD).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study was based on the Born in Guangzhou Cohort Study (BIGCS), a prospective cohort study conducted in Guangzhou, China. The protocol of BIGCS was described in detail previously [20]. In brief, women who planned to give birth at the Guangzhou Women and Children's Medical Center and live in Guangzhou for at least 3 years after delivery were invited to participate in the BIGCS at their first antenatal visit (< 20 weeks' gestation). The study was approved by the Institutional Ethics Committee of the Guangzhou Women and Children's Medical Center. Before recruitment, written informed consent was obtained from all participants. Inclusion criteria for the current study were (1) pregnant women aged 18 years or above, (2) singleton pregnancies and (3) pre-pregnancy BMI < 18.5 kg/m2. The exclusion criteria were as follows: (1) withdrew before delivery, (2) diagnosed with diabetes, hypertension, and heart disease before pregnancy, (3) terminations of pregnancy or stillbirths, (4) multiple g
Key inclusion criteria (1 listed)
- The pregnant women in Born in Guangzhou Cohort Study
Key exclusion criteria (2 listed)
- The fetuses with prenatal diagnosis of congenital heart disease or other congenital diseases.
- The fetuses who are high-risk neonates at the delivery.1) preterm infants; (2) infants with extremely low birth weight (ELBW) or who are small for gestational age (SGA);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Birth
Time frame: 20 weeks follow up
Healthy birth
1 secondary outcome
low birth weight
Time frame: 20 weeks follow up
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 4 Jun 2025.
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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 Growth Retardation and Fetal Neurodevelopmental Disorder, run by Guangzhou Women and Children's Medical Center 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 2 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 4 Jun 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?
Birth (time frame: 20 weeks follow up). 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 4 Jun 2025.