NCT03925064

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 23, 2019

Completed
Last Updated

December 10, 2019

Status Verified

April 1, 2019

Enrollment Period

8 months

First QC Date

April 19, 2019

Last Update Submit

December 7, 2019

Conditions

Gestational DiabetesMyocardial Dysfunction

Outcome Measures

Primary Outcomes (1)

  • ultrasonographic myocardial performance index values

    cardiac contractility will be measured with Doppler ultrasonography

    during procedure

Study Arms (2)

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

myocardial performance indexOTHER

fetal right ventricular myocardial performance index measured with tissue doppler

Diabetic pregnanciesnon-diabetic pregnancies

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

18-40 years old pregestational or gestational diabetic women

You may qualify if:

  • years old pregnant women

You may not qualify if:

  • fetal cardiac anomalies
  • multiple gestations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni SSRTH

Istanbul, 34303, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Md, ObGYN, Principal Investigator

Study Record Dates

First Submitted

April 19, 2019

First Posted

April 23, 2019

Study Start

August 1, 2018

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

December 10, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)