Screening Hepatitis Positive Women for Congenital Anomalies | NCT03980301

Studies
Screening Hepatitis Positive Women for Congenital Anomalies

NCT03980301

Sponsor

Aljazeera Hospital

Status

Completed

Last Update Posted

Nov 3, 2020Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Hepatitis C

Interventions

ultrasound

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

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 11, 2018Actual

Primary Completion Date

Jun 15, 2020Actual

Completion Date

Oct 20, 2020Actual

First Submitted Date

Jun 6, 2019

First Submission Date that Met QC Criteria

Jun 6, 2019

First Posted Date

Jun 10, 2019Actual

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

Oct 31, 2020

Last Update Posted Date

Nov 3, 2020Actual

Name	Class
National Research Centre, Egypt	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasound	Diagnostic Test	screening of pregnant women with hepatitis c virus received treatment in first trimester for congenital anomalies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the number of pregnant women who will be diagnosed to have fetuses with congenital anomalies	the number of pregnant women who will be diagnosed to have fetuses with congenital anomalies by us	within 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women with hepatitis C virus received treatment during first trimester

Exclusion Criteria:

pregnant women with hepatitis C virus who didnot receive treatment during first trimester

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnant women with hepatitis C virus

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Pregnant women with hepatitis C virus received treatment during first trimester

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mahmoud Alalfy	Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Algazeerah		Giza			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014463	Ultrasonography

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided