Gestational DiabetesNCT03925064
Fetal Myocardial Performance Index in Diabetic Pregnancies
An observational study of Gestational Diabetes and Myocardial Dysfunction, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes, Myocardial Dysfunction
- What is being tested?
- myocardial performance index
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2018to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
Study population: 18-40 years old pregestational or gestational diabetic women
Who may be able to join
- 18-40 years old pregnant women
Who cannot join
- fetal cardiac anomalies
- multiple gestations
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Gestational Diabetes, Myocardial Dysfunction
- Being tested
- myocardial performance index
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myocardial performance indexOther
fetal right ventricular myocardial performance index measured with tissue doppler
| Study group | Role | What they receive |
|---|---|---|
| Diabetic pregnancies | Pregnant women with pregestational or gestational diabetes mellitus Receives: Other: myocardial performance index | |
| non-diabetic pregnancies | Pregnant women without pregestational or gestational diabetes mellitus Receives: Other: myocardial performance index |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasonographic myocardial performance index values
cardiac contractility will be measured with Doppler ultrasonography
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start1 Aug 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925064
- Sponsor's protocol ID
- 2018.7.06
- Status last verified
- Apr 2019
- First submitted
- 19 Apr 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Myocardial Performance Index in Diabetic Pregnancies
- ClinicalTrials.gov ID
- NCT03925064
- Acronym / sponsor ID
- 2018.7.06
- Conditions
- Gestational Diabetes, Myocardial Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic pregnancies | – | Other: myocardial performance indexPregnant women with pregestational or gestational diabetes mellitus |
| non-diabetic pregnancies | – | Other: myocardial performance indexPregnant women without pregestational or gestational diabetes mellitus |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 18-40 years old pregestational or gestational diabetic women
Key inclusion criteria (1 listed)
- 18-40 years old pregnant women
Key exclusion criteria (2 listed)
- fetal cardiac anomalies
- multiple gestations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| myocardial performance indexfetal right ventricular myocardial performance index measured with tissue doppler | Other | Diabetic pregnancies, non-diabetic pregnancies |
Primary outcome
ultrasonographic myocardial performance index values
Time frame: during procedure
cardiac contractility will be measured with Doppler ultrasonography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and Myocardial Dysfunction, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ultrasonographic myocardial performance index values (time frame: during procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2019.