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Fetal Myocardial Performance Index in Diabetic Pregnancies

NCT ID: NCT03925064

Last Updated: 2019-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-03-31

Brief Summary

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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

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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.

Conditions

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Gestational Diabetes Myocardial Dysfunction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetic pregnancies

Pregnant women with pregestational or gestational diabetes mellitus

myocardial performance index

Intervention Type OTHER

fetal right ventricular myocardial performance index measured with tissue doppler

non-diabetic pregnancies

Pregnant women without pregestational or gestational diabetes mellitus

myocardial performance index

Intervention Type OTHER

fetal right ventricular myocardial performance index measured with tissue doppler

Interventions

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myocardial performance index

fetal right ventricular myocardial performance index measured with tissue doppler

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18-40 years old pregnant women

Exclusion Criteria

* fetal cardiac anomalies
* multiple gestations
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Berna Aslan Cetin

Md, ObGYN, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kanuni SSRTH

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2018.7.06

Identifier Type: -

Identifier Source: org_study_id