- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03925064
Fetal Myocardial Performance Index in Diabetic Pregnancies
December 7, 2019 updated by: Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
130
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey, 34303
- Kanuni SSRTH
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
18-40 years old pregestational or gestational diabetic women
Description
Inclusion Criteria:
- 18-40 years old pregnant women
Exclusion Criteria:
- fetal cardiac anomalies
- multiple gestations
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Diabetic pregnancies
Pregnant women with pregestational or gestational diabetes mellitus
|
fetal right ventricular myocardial performance index measured with tissue doppler
|
non-diabetic pregnancies
Pregnant women without pregestational or gestational diabetes mellitus
|
fetal right ventricular myocardial performance index measured with tissue doppler
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ultrasonographic myocardial performance index values
Time Frame: during procedure
|
cardiac contractility will be measured with Doppler ultrasonography
|
during procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2018
Primary Completion (Actual)
March 31, 2019
Study Completion (Actual)
March 31, 2019
Study Registration Dates
First Submitted
April 19, 2019
First Submitted That Met QC Criteria
April 19, 2019
First Posted (Actual)
April 23, 2019
Study Record Updates
Last Update Posted (Actual)
December 10, 2019
Last Update Submitted That Met QC Criteria
December 7, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018.7.06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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