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Cardiac Septal Hypertrophy in the Fetus of Diabetic Mother and Its Effect on Postnatal Cardiac Function

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by heba mohamed, Ain Shams Maternity Hospital.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01599026
First Posted: May 15, 2012
Last Update Posted: May 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
heba mohamed, Ain Shams Maternity Hospital
  Purpose
Good glycemic control is superior to poor glycemic control in reducing risk of interventricular septum thickness among fetuses of diabetic mothers

Condition
Cardiology in Fetus of Diabetic Mother

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Cardiac Septal Hypertrophy in the Fetus of Diabetic Mother and Its Effect on Postnatal Cardiac Function

Further study details as provided by heba mohamed, Ain Shams Maternity Hospital:

Primary Outcome Measures:
  • To study interventricular septum thickness in fetus of diabetic mother and correlate it with good glycemic control. [ Time Frame: one year ]
    To study interventricular septum thickness in fetus of diabetic mother and correlate it with good glycemic control during third trimester of pregnancy.


Secondary Outcome Measures:
  • cardiac function in infant of diabetic mother [ Time Frame: one year ]
    To correlate postnatal cardiac function to interventricular septum thickness to reach cut of value of septum thickness for prenatal prediction of symptomatic cardiomyopathy in infant of diabetic mother.


Estimated Enrollment: 120
Study Start Date: April 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Detailed Description:
Good glycemic control is superior to poor glycemic control in reducing risk of interventricular septum thickness among fetuses of diabetic mothers specially during third trimester of pregnancy
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
diabetic pregnant ladies gestational age more than 35 weeks
Criteria

Inclusion Criteria:

  • singleton pregnancy
  • gestational age 36 weeks

Exclusion Criteria:

  • congenital anomalies
  • obstetric complications
  • medical disorders other than diabetes
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599026


Locations
Egypt
AinShamsMH
Cairo, Egypt, 44511
Sponsors and Collaborators
Ain Shams Maternity Hospital
  More Information

Responsible Party: heba mohamed, Cardiac septal hypertrophy in the fetus of diabetic mother and its effect on postnatal cardiac function, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT01599026     History of Changes
Other Study ID Numbers: dhvf 7531
First Submitted: May 14, 2012
First Posted: May 15, 2012
Last Update Posted: May 15, 2012
Last Verified: May 2012

Keywords provided by heba mohamed, Ain Shams Maternity Hospital:
cardiology
fetus of diabetic mother

Additional relevant MeSH terms:
Hypertrophy
Pathological Conditions, Anatomical