NCT06410391

Brief Summary

The aim of our study is to determine the range of frontal horn sizes (both upside and downside) in healthy fetuses over gestation and to determine how far FHs are from the midline . Also to determine the range of cavum septi pellucidi and Corpus callosum sizes . Also, to determine whether the maternal body mass index (BMI) affects rates of visualized and non-visualized CSP and CC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 3, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 13, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

June 15, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2024

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2024

Completed
Last Updated

December 18, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

May 3, 2024

Last Update Submit

December 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Determine the range of lateral ventricles diameter in healthy fetuses at different gestational ages.,

    Diameter of Lateral ventricles measured by ultrasound in millimeters

    5 months

Secondary Outcomes (1)

  • measurement of Cavum septum and Corpus callosum

    5 months

Interventions

UltrasoundRADIATION

Gestational age, biparietal diameter and head circumference are measured. then 2 techniques are used according to the 2007 International Society of Ultrasound in Obstetrics and Gynecology guidelines for a US evaluation of the fetal central nervous system (CNS) (10) : 1- the axial transventricular technique including the posterior portions of the lateral ventricles, falx, CSP, and Frontal horn 2- the trans-cerebellar technique, including the cerebellum, cisternal magna, cerebellar peduncles, CSP, and FHs. CSP visualization and width, FH width, anterior horn width (AHW), center from the horn distance (CFHD), upside and downside measurement. The corpus callosum is identified in the midsagittal plane. The image selected for CC measurement in addition to cerebellar vermis and cisterna magna

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All healthy pregnant women came to fetal medicine unit at 15 to 36 weeks

You may qualify if:

  • pregnant woman 15 weeks to 36 weeks

You may not qualify if:

  • congenital malformations
  • Multiple pregnancy
  • intrauterine infection
  • fetuses with Fetal growth restriction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women Health Hospital

Asyut, Egypt

Location

MeSH Terms

Conditions

Congenital Abnormalities

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obs& Gyn. Specialist of Urogynecology

Study Record Dates

First Submitted

May 3, 2024

First Posted

May 13, 2024

Study Start

June 15, 2024

Primary Completion

December 2, 2024

Study Completion

December 11, 2024

Last Updated

December 18, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations