Fetal DiagnoseNCT05737043
Modified Myocardial Performance Index and Epicardial Thickness in Cases With Idiopathic Polyhydramnios
A study testing prenatal diagnose in people with Fetal Diagnose and Fetal Cardiac Disorder, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
In cases diagnosed as idiopathic polyhydramnios and healthy pregnancy between 24-40 weeks (total number of cases (100-120)), prospective fetal echocardiography will be performed to evaluate MPI and EFT. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Diagnose, Fetal Cardiac Disorder
- What is being tested?
- prenatal diagnose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jul 2022to 12 Feb 2023
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Inclusion Criteria: 24-40 weeks gestational age, polyhydramnios and healthy pregnancy -
Exclusion Criteria: multıpl pregnancy, fetal anomaly, growth restriction, maternal chronic disease
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Modified Myocardial Performance Index and Epicardial Thickness in Cases With Idiopathic Polyhydramnios and in Healthy Normal Pregnancies
In cases diagnosed as idiopathic polyhydramnios and healthy pregnancy between 24-40 weeks (total number of cases (100-120)), prospective fetal echocardiography will be performed to evaluate MPI and EFT.
Read the detailed description
: gestational week, maternal age, amniotic fluid index measurement, modified myocardial performance in fetal echo and epicardial thickness of all cases will be evaluated. week of pregnancy, body mass index, fetal biometry, umbilical artery doppler, middle cerebral artery doppler measurements will be taken. Birth weight and fetal intensive care hospitalizations at the birth week of all cases will be recorded. All data will be evaluated with the appropriate statistical method.
- Conditions
- Fetal Diagnose, Fetal Cardiac Disorder
- Being tested
- prenatal diagnose
- Keywords
- polyhidramnios, epicard, myocardial performance index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prenatal diagnoseDiagnostic test
we will do a fetal echo in pregnant women with polyhidramnios
| Study group | Role | What they receive |
|---|---|---|
| myocardial performance and epicard thickness in case with polyhidramnios | Placebo comparator | we will do a fetal echo, and fetal screening with ultrasonography Receives: Diagnostic Test: prenatal diagnose |
| pregnant women with polyhidramios | Active comparator | Not described Receives: Diagnostic Test: prenatal diagnose |
What is being measured
The primary outcome is the main question the study is designed to answer.
neonatal and fetal outcome
Do epicardial thickness and myocardial performance index determine fetal outcome in cases with polyhdramnios?
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start22 Jul 2022
- Primary completion12 Feb 2023
- Study completion12 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal DiagnoseStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, şükran doğru, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737043
- Sponsor's protocol ID
- 2023/4145(10675: neu)
- Status last verified
- Feb 2023
- First submitted
- 12 Feb 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I want to share it as an article when the results are collected
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Modified Myocardial Performance Index and Epicardial Thickness in Cases With Idiopathic Polyhydramnios and in Healthy Normal Pregnancies
- ClinicalTrials.gov ID
- NCT05737043
- Acronym / sponsor ID
- 2023/4145(10675: neu)
- Conditions
- Fetal Diagnose, Fetal Cardiac Disorder
- Keywords
- polyhidramnios, epicard, myocardial performance index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 12 Feb 2023 (actual)
- Study completion
- 12 Feb 2023 (actual)
- First posted
- 21 Feb 2023 (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.
In cases diagnosed as idiopathic polyhydramnios and healthy pregnancy between 24-40 weeks (total number of cases (100-120)), prospective fetal echocardiography will be performed to evaluate MPI and EFT.
Detailed description
: gestational week, maternal age, amniotic fluid index measurement, modified myocardial performance in fetal echo and epicardial thickness of all cases will be evaluated. week of pregnancy, body mass index, fetal biometry, umbilical artery doppler, middle cerebral artery doppler measurements will be taken. Birth weight and fetal intensive care hospitalizations at the birth week of all cases will be recorded. All data will be evaluated with the appropriate statistical method.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| myocardial performance and epicard thickness in case with polyhidramnios | Placebo comparator | Diagnostic Test: prenatal diagnosewe will do a fetal echo, and fetal screening with ultrasonography |
| pregnant women with polyhidramios | Active comparator | Diagnostic Test: prenatal diagnose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| prenatal diagnosewe will do a fetal echo in pregnant women with polyhidramnios | Diagnostic test | myocardial performance and epicard thickness in case with polyhidramnios, pregnant women with polyhidramios |
Primary outcome
neonatal and fetal outcome
Time frame: 1 year
Do epicardial thickness and myocardial performance index determine fetal outcome in cases with polyhdramnios?
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 21 Feb 2023.
- Individual participant dataSharing planned: Undecided. I want to share it as an article when the results are collected
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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?
A study testing prenatal diagnose in people with Fetal Diagnose and Fetal Cardiac Disorder, run by Necmettin Erbakan University 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?
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 21 Feb 2023. 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. Some participants in this study may receive a placebo. 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?
neonatal and fetal outcome (time frame: 1 year). 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 21 Feb 2023.