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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
heba mohamed, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier:
NCT01599026
First received: May 14, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599026

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

No publications provided

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
Study First Received: May 14, 2012
Last Updated: May 14, 2012
Health Authority: Egypt:AinShamsMH

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

Additional relevant MeSH terms:
Hypertrophy
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 26, 2014