Clinical trial NCT07004283: Fetal Magnetic Resonance Imaging: Z-score Reference Ranges for a Large Patient Population in Normal Neuroimaging Measurement
Official title: Fetal Magnetic Resonance Imaging: Z-score Reference Ranges for a Large Patient Population in Normal Neuroimaging Measurement
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Fetal Growth Retardation
Fetal Neurodevelopmental Disorder
Keywords: z-score
healthy reference range
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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 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).


Eligibility criteria: Inclusion Criteria:

* The pregnant women in Born in Guangzhou Cohort Study

Exclusion Criteria:

* 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);

Primary outcomes:
measure: Birth
timeFrame: 20 weeks follow up
Secondary outcomes:
measure: low birth weight
timeFrame: 20 weeks follow up
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Siemens Skyra 3.0T MRI
state: Guangdong
Study officials:
References: