Interventricular Cardiac Septal Thickness in Fetus of Dia... | NCT02136602

Studies
Interventricular Cardiac Septal Thickness in Fetus of Diabetic Mother Correlated to Postnatal Outcome

NCT02136602

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

May 13, 2014Estimated

Enrollment

120Actual

Phase

Not provided

Conditions

Maternal Diabetes Mellites Effect on Fetus

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

May 2014

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

Jan 2012

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Nov 6, 2013

First Submission Date that Met QC Criteria

May 9, 2014

First Posted Date

May 13, 2014Estimated

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

May 9, 2014

Last Update Posted Date

May 13, 2014Estimated

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

Good glycemic control is superior to poor glycemic control in reducing risk of interventricular septal thickness among fetuses of diabetic mothers.

Detailed Description

Thick Interventricular septum is thought to be related to poor glycemic control during pregnancy, and it causes variable degree of left ventricular outflow obstruction and hypertrophic cardiomyopathy.

Hypertrophic cardiomyopathy requires specific management as digoxin and inotropic agents usually used in heart failure are contraindicated.

So high index of suspicion is required in fetus of diabetic mother having thick Inter ventricular septum.

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

2 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

120Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To study interventricular septal thickness in fetus of diabetic mother and correlate it with good glycemic control.		6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

above 35 weeks pregnancy
diabetic mothers
single intrauterine pregnancy

Exclusion Criteria:

any other medical disorder

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

pregnant women with diabetes mellites

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohammed M Elsafty, obs&gyn lecturer.	Ain Shames university	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AinShamsU		Cairo		3285	Egypt