Placental Assessment in Diabetic Mothers | NCT04149548

Studies
Placental Assessment in Diabetic Mothers

NCT04149548

Sponsor

Aljazeera Hospital

Status

Unknown status

Last Update Posted

Feb 6, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Diabetes

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

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 5, 2019Actual

Primary Completion Date

Nov 6, 2020Estimated

Completion Date

Dec 1, 2020Estimated

First Submitted Date

Oct 31, 2019

First Submission Date that Met QC Criteria

Oct 31, 2019

First Posted Date

Nov 4, 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

Feb 4, 2020

Last Update Posted Date

Feb 6, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mahmoud Alalfy, Researcher ,National research centre and Algezeera hospital, Aljazeera HospitalPrincipal Investigator

Lead Sponsor

Aljazeera HospitalOTHER

Collaborators

Not provided

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

Description Module

Brief Summary

Diabetes mellitus is one of the major heath problems

Detailed Description

Maternal and fetal effects are edpected to be more than in diabetic mothers

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pregnant diabetic women		Fetal Ultrasound to diabetic pregnant women	Diagnostic Test: ultrasound
non diabetic pregnant women		Fetal ultrasound to non diabetic pregnant women	Diagnostic Test: ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasound	Diagnostic Test	Obstetric ultrasound to pregnant women	non diabetic pregnant women pregnant diabetic women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of diabetic fetuses who will have undesirable effects	Number of fetuses with macrosomia and other diabetes effects	within 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

in control group A non diabetic pregnant women

Exclusion Criteria:

Diabetic pregnant women

And the reverse in group B

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant women

Minimum Age

20 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

Diabetic and non diabetic pregnanrt women attending for ANC

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud Alalfy, PhD	Contact	01002611058		mahmoudalalfy@ymail.com

Overall Officials

Name	Affiliation	Role
Mahmoud Alalfy, PhD	Algezeera	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Algazeerah and Kasralainy hospital	Recruiting	Giza			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

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