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NCT03925064 Clinical Trial

Fetal Myocardial Performance Index in Diabetic Pregnancies

Gestational Diabetes Clinical Trial

Official title:
Fetal Myocardial Performance Index in Diabetic Pregnancies

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03925064
Other study ID # 2018.7.06
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2018
Est. completion date March 31, 2019

Study information
Verified date April 2019
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The myocardial tissue is the most likely structure affected by hyperglycemia. The myocardial performance index (MPI) is a pulsed wave Doppler-derived index of global myocardial function. It is defined as the sum of the isovolumetric contraction time (ICT) and isovolumetric relaxation time (IRT) divided by the ejection time (ET) The fetal right heart contributes more to the cardiac output than the left heart; therefore, it is important to assess the right ventricular function. The investigators will measure right ventricular MPI in diabetic and normal pregnancies.

Description:

Gestational diabetes mellitus (GDM) is the most common metabolic disorder in pregnancy, with an overall prevalence of 3-7 % during pregnancy. The myocardial tissue is the most likely structure affected by hyperglycemia. The myocardial performance index (MPI) is a pulsed wave Doppler-derived index of global myocardial function. It is defined as the sum of the isovolumetric contraction time (ICT) and isovolumetric relaxation time (IRT) divided by the ejection time (ET) The fetal right heart contributes more to the cardiac output than the left heart; therefore, it is important to assess the right ventricular function. The investigators will measure right ventricular MPI in diabetic and normal pregnancies.

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date March 31, 2019
Est. primary completion date March 31, 2019
Accepts healthy volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- 18-40 years old pregnant women

Exclusion Criteria:

- fetal cardiac anomalies

- multiple gestations

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• myocardial performance index
fetal right ventricular myocardial performance index measured with tissue doppler

Locations
Country Name City State
Turkey Kanuni SSRTH Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary ultrasonographic myocardial performance index values cardiac contractility will be measured with Doppler ultrasonography during procedure
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