NCT07169929

Brief Summary

The thalamus is a nuclear complex which located in the diencephalon of the brain. Its main function is to relay messages which affect the sensory and motor functions in the body. A lot of behavioral functions are accredited to it such as memory, learning, attention and language. (Sridar P,et al 2020) There is an automatic thalamic diameter measurement to estimate the thalamic diameter, with the measurement accuracy as good as the clinical assessment.( Sridar P,et al 2016) Transverse thalamic diameter increased significantly with increasing gestational age, head circumference, and trans-cerebellar diameter linearly, and normal range thalamic charts are presented. The guitar shape provided good reproducibility of thalamic diameter measures. (Sridar P,et al 2020) Also the evaluation of echogenic thalamus is beneficial, and can be considered as a new marker of fetal lung maturity. ( Rasheed FA, et al 2012). Maternal hyperglycemia was significantly associated with an increase in the widths of fetal posterior lateral ventricles, cavum septum pellucidi, and cisterna magna and a decrease in fetal trans-cerebellar diameter with no difference was found between three groups in terms of fetal thalamus size (Ekin A. et al 2023). However, little is known about the growth pattern of thalami during fetal life, and virtually nothing is known about the possible association of deviations from the normal growth pattern with the abnormal conditions. There is a study published on fetal thalami which compare the volumes of cerebral structures, including thalami, between two group's normally growing and growth-restricted fetuses and reported lack of significant difference in thalamic volumes between the two groups. (Elshal RS.etal 2023). During fetal life, the thalamus increases in size between the ages of 20 to 43 weeks of gestation (Tutunji R et al 2018 ) The development of the thalamus is not a unified progress as it shows remarkable dynamism and heterogeneity ( Zheng et al., 2023) For example, before 35 weeks post-menstrual age ,morphological changes were relatively uniform across the thalamus, and after 35 weeks post menstrual age, deformation was more obvious at the rim than in the central part of the thalamus (Liu et al., 2021). Prospective research ensures focused attention to the structures to be measured, with more clearly imaged by the operator and using variable contrast resolution to ensuring clarity of the measured structure and prevent any artefacts which prevent visualization. .( Sridar P etal 2020) While Ultrasound allows the measurement of the fetal brain in real time and has fewer artefacts from the movement of the fetus, it is operator dependent. (Bookstein S etal 2024).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

September 20, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

March 3, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

September 5, 2025

Last Update Submit

March 2, 2026

Conditions

Keywords

Transverse thalamic diameter - fetal growth - 2Dultrasound

Outcome Measures

Primary Outcomes (1)

  • Realibity of transverse thalamic diameter as a parameter for fetal growth

    Correlation of measuring the transverse thalamic diameter in determining the gestational age between 18 weeks and 36 weeks according to this equation (Transverse thalamic Diameter( in mm)=0.912 x Gestational age in weeks -1.134) ( Sridar P, et al 2020)

    6months

Study Arms (1)

Healthy pregnant women who will meet the inclusion criteria and attend the feto-maternal unit

Other: Measurement of fetal transverse thalamic diameter by 2dimensional abdominal ultrasound

Interventions

All pregnant women attending the feto-maternal unit with gestational age from 18 weeks to 36 weeks in the obstetrics and gynecology department in the faculty of medicine Cairo university Using curvilinear 2D transabdominal ultrasound probe of ultrasound machine either Voluson E10 GE or Nuewa I9 Elite Mindray. The investigators will take all the biometry (Biparietal diameter, head circumference, abdominal circumference, femur length and trans-cerebellar diameter) and exclude any congenital anomalies in the scan. Transverse thalamic diameter is to be measured by 2D ultrasound at the standard axial trans-cerebellar plane. A guitar shape representative structure is presented to demarcate the thalamic diameter. Calculate the gestational age using transverse thalamic diameter from this equation Transverse thalamic Diameter( in mm)=0.912 x Gestational age in weeks -1.134) ( Sridar P, et al 2020)

Healthy pregnant women who will meet the inclusion criteria and attend the feto-maternal unit

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy pregnant women who will meet the inclusion criteria and attend the feto-maternal unit in the department of obstetrics and gynecology faculty of medicine Cairo university consent to participate in the research study

You may qualify if:

  • All pregnant women with singleton pregnancy with gestational age between 18 to 36 weeks

You may not qualify if:

  • Women who are not sure of dates and don't have an US report with CRL measured in the first trimester
  • Maternal obesity (BMI\>35) as abdominal fat cause restriction in taking measurement
  • Known case of DM or Hypertension or SLE
  • Any fetal head or CNS anomalies
  • Any maternal opiates and CNS drugs (methadone) IUGR
  • Twins or multiple pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaimaa El Shemy

Giza, Cairo Governorate, 4240310, Egypt

RECRUITING

Central Study Contacts

Shaimaa El Shemy, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

September 5, 2025

First Posted

September 12, 2025

Study Start

September 20, 2025

Primary Completion

March 20, 2026

Study Completion

March 30, 2026

Last Updated

March 3, 2026

Record last verified: 2026-03

Locations