Fetal Heart Interventricular Septum in Fetuses of Diabeti... | NCT01845324

Studies
Fetal Heart Interventricular Septum in Fetuses of Diabetic Mothers

NCT01845324

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

May 3, 2013Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Pregnancy
Diabetes Mellitus

Interventions

Not provided

Countries

Israel

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

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

May 2014Estimated

Completion Date

Jun 2014Estimated

First Submitted Date

Apr 9, 2013

First Submission Date that Met QC Criteria

Apr 30, 2013

First Posted Date

May 3, 2013Estimated

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

Apr 30, 2013

Last Update Posted Date

May 3, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The investigators asume that the measurement of the fetal heart interventricular septum can serve as a good tool to predict glucose control in pregnant patients with diabetes mellitus. The investigators will measure the septum width in patients with Diabetes and will correlate to standard measurements of the glucuse levels.

Detailed Description

In this study the investigators will follow patients with Diabetes Mellitus - mainly gestational. the investigators will measure the width of the interventricular septum and correlate with conventional measures of blood glucose measurements in this population.

The investigators will try to assess whether measurement of the septum can be an earlier and better predictor of glucose control in this population.

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

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diabetes Mellitus in pregnancy		Our cohort will include all consequtive women with Diabetes Mellitus atending our clinic

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
width of fetal interventricula heart septum	The investigator will assess the width of the fetal interventricular septum in patients with diabetes.	2 years

Secondary Outcomes

Measure	Description	Time Frame
glucose control in patients with normal and abnormal interventricular septal width	The investigators will try to show that small interventricular septal width glucose correlates with good glucose control	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All consequtive pregnant women
with Diabetes Mellitus - Gestational and non Gestational

Exclusion Criteria:

.No willing to participate.

Suspected Heart anomaly

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

All consequtive pregnant women with Diabetes Mellitus - Gestational and non Gestational

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alon Shrim, MD	Contact	+972-4-6188224		alon.shrim@gmail.com

Overall Officials

Name	Affiliation	Role
Alon Shrim, MD	Hillel Yaffe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera		38100	Israel

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