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Fetal Myocardial Performance Index in Diabetic Pregnancies

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ClinicalTrials.gov Identifier: NCT03925064
Recruitment Status : Completed
First Posted : April 23, 2019
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Gestational Diabetes Myocardial Dysfunction Other: myocardial performance index

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 Design
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Study Type : Observational
Actual Enrollment : 130 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Fetal Myocardial Performance Index in Diabetic Pregnancies
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2019

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Diabetic pregnancies
Pregnant women with pregestational or gestational diabetes mellitus
 Other: myocardial performance index
fetal right ventricular myocardial performance index measured with tissue doppler
non-diabetic pregnancies
Pregnant women without pregestational or gestational diabetes mellitus
 Other: myocardial performance index
fetal right ventricular myocardial performance index measured with tissue doppler


Outcome Measures
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Primary Outcome Measures :
  1. ultrasonographic myocardial performance index values [ Time Frame: during procedure ]
    cardiac contractility will be measured with Doppler ultrasonography


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
18-40 years old pregestational or gestational diabetic women
Criteria

Inclusion Criteria:

  • 18-40 years old pregnant women

Exclusion Criteria:

  • fetal cardiac anomalies
  • multiple gestations
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925064


Locations
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Turkey
Kanuni SSRTH
Istanbul, Turkey, 34303
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
More Information
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Responsible Party: Berna Aslan Cetin, Md, ObGYN, Principal Investigator, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03925064    
Other Study ID Numbers: 2018.7.06
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy in Diabetics
Pregnancy Complications
Diabetes Mellitus
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases