Differences Between Male and Femal Fetal Brain Biometry b... | NCT06544967

Studies
Differences Between Male and Femal Fetal Brain Biometry by Ultrasound

NCT06544967

Sponsor

Sohag University

Status

Recruiting

Last Update Posted

Aug 9, 2024Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Fetal Brain Biometry by Ultrasound

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2024Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Jun 1, 2025Estimated

First Submitted Date

Aug 6, 2024

First Submission Date that Met QC Criteria

Aug 6, 2024

First Posted Date

Aug 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2024

Last Update Posted Date

Aug 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Differences of fetal brain biometry as Biparietal diameter,Head circumference,Transcerebellar diameter, Cavum septum pellucidum as regard to fetal gender by ultrasound

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Male fetuses between 18 to 36 weeks		Ultrasound biometry
Female fetuses between 18 to 36 weeks		Ultrasound biometry

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fetal brain biometry	In male and female fetuses	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy women from 18 to 36 weeks gestation of pregnant cases aged from 18 to 40 years normal body mass index range from 18 to 25

Exclusion Criteria:

Pregnant women with any chronic or systemic disease and fetuses with chromosome anomalies or developmental retardation were not included in the study

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

healthy women from 18 to 36 weeks gestation of pregnant cases aged from 18 to 40 years normal body mass index range from 18 to 25

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abdelrhman F Mahmoud	Contact	01141243928		abdelrahman_fathy_post@med.sohag.edu.eg
Allam M Abdelmonem, Professor	Contact

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag university hospital	Recruiting	Sohag			Egypt