Fetal Myocardial Performance Index in Diabetic Pregnancies | NCT03925064

Studies
Fetal Myocardial Performance Index in Diabetic Pregnancies

NCT03925064

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Status

Completed

Last Update Posted

Dec 10, 2019Actual

Enrollment

130Actual

Phase

Not provided

Conditions

Gestational Diabetes
Myocardial Dysfunction

Interventions

myocardial performance index

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2018Actual

Primary Completion Date

Mar 31, 2019Actual

Completion Date

Mar 31, 2019Actual

First Submitted Date

Apr 19, 2019

First Submission Date that Met QC Criteria

Apr 19, 2019

First Posted Date

Apr 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2019

Last Update Posted Date

Dec 10, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Berna Aslan Cetin, Md, ObGYN, Principal Investigator, Kanuni Sultan Suleyman Training and Research HospitalPrincipal Investigator

Lead Sponsor

Kanuni Sultan Suleyman Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diabetic pregnancies		Pregnant women with pregestational or gestational diabetes mellitus	Other: myocardial performance index
non-diabetic pregnancies		Pregnant women without pregestational or gestational diabetes mellitus	Other: myocardial performance index

Interventions

Name	Type	Description	Arm Group Labels	Other Names
myocardial performance index	Other	fetal right ventricular myocardial performance index measured with tissue doppler	Diabetic pregnancies non-diabetic pregnancies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ultrasonographic myocardial performance index values	cardiac contractility will be measured with Doppler ultrasonography	during procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-40 years old pregnant women

Exclusion Criteria:

fetal cardiac anomalies
multiple gestations

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

18-40 years old pregestational or gestational diabetic women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kanuni SSRTH		Istanbul		34303	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016640	Diabetes, Gestational

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003920	Diabetes Mellitus

Browse Leaves

Not provided

Browse Branches

Not provided