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NCT01845324 Clinical Trial

Fetal Heart Interventricular Septum in Fetuses of Diabetic Mothers

Diabetes Mellitus Clinical Trial

Official title:
Relation Between Fetal Heart Interventricular Septum Size and Gestational Diabetes Mellitus Control. a Prospective Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01845324
Other study ID # 0011-13
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 9, 2013
Last updated April 30, 2013
Start date May 2013
Est. completion date June 2014

Study information
Verified date April 2013
Source Hillel Yaffe Medical Center
Contact Alon Shrim, MD
Phone +972-4-6188224
Email alon.shrim@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date June 2014
Est. primary completion date May 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- All consequtive pregnant women

- with Diabetes Mellitus - Gestational and non Gestational

Exclusion Criteria:

.No willing to participate.

- Suspected Heart anomaly

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary width of fetal interventricula heart septum The investigator will assess the width of the fetal interventricular septum in patients with diabetes. 2 years No
Secondary 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 No
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