NCT01845324

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 3, 2013

Status Verified

April 1, 2013

Enrollment Period

1 year

First QC Date

April 9, 2013

Last Update Submit

April 30, 2013

Conditions

PregnancyDiabetes Mellitus

Keywords

PregnancyDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • glucose control in patients with normal and abnormal interventricular septal width

    2 years

Study Arms (1)

Diabetes Mellitus in pregnancy

Our cohort will include all consequtive women with Diabetes Mellitus atending our clinic

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • No willing to participate.
  • Suspected Heart anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Alon Shrim, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alon Shrim, MD

CONTACT

+972-4-6188224alon.shrim@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2013

First Posted

May 3, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

May 3, 2013

Record last verified: 2013-04

Locations

IL(1)