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

Cardiology in Fetus of Diabetic Mother Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01599026
• Other study ID #: dhvf 7531
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 14, 2012
• Last updated: May 14, 2012
• Start date: April 2012
• Est. completion date: March 2013

Study information

• Verified date: May 2012
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt:AinShamsMH
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• singleton pregnancy

• gestational age 36 weeks

Exclusion Criteria:

• congenital anomalies

• obstetric complications

• medical disorders other than diabetes

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cardiology in Fetus of Diabetic Mother
• Hypertrophy

Locations

Country	Name	City	State
Egypt	AinShamsMH	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study interventricular septum thickness in fetus of diabetic mother and correlate it with good glycemic control.	To study interventricular septum thickness in fetus of diabetic mother and correlate it with good glycemic control during third trimester of pregnancy.	one year	No
Secondary	cardiac function in infant of diabetic mother	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.	one year	No