Fetal Myocardial Performance Index in Diabetic Pregnancies

Completed

• Conditions: Gestational Diabetes; Myocardial Dysfunction
• Interventions: Other: myocardial performance index

• Registration Number: NCT03925064
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-08-01
• Primary Completion: 2019-03-31
• Study Completion: 2019-03-31
• Status Verified: 2019-04
• Study First Submitted: 2019-04-19
• Study First Submitted QC: 2019-04-19
• Study First Posted: 2019-04-23
• Last Update Submitted: 2019-12-07
• Last Update Posted: 2019-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

• 18-40 years old pregnant women

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Exclusion Criteria

• fetal cardiac anomalies
• multiple gestations

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic pregnancies	myocardial performance index	Pregnant women with pregestational or gestational diabetes mellitus
non-diabetic pregnancies	myocardial performance index	Pregnant women without pregestational or gestational diabetes mellitus

Primary Outcome Measures

Name	Time	Method
ultrasonographic myocardial performance index values	during procedure	cardiac contractility will be measured with Doppler ultrasonography

Trial Locations

Locations (1)

Kanuni SSRTH; 🇹🇷 Istanbul, Turkey