Fetus FetusEFTNCT05948319
the Fetal Epicardial Thickness in Obese Pregnant Women (EFT)
A study testing Doppler ultrasonography in people with Fetus Fetus and Pregnancy Complications, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
the effects of fetal EFT on fetal cardiac function and fetal and maternal outcomes were investigated in obese pregnant women compared with normal-weight pregnant women. 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
- Fetus Fetus, Pregnancy Complications
- What is being tested?
- Doppler ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 30 Apr 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
Who may be able to join
- Obese pregnant women
- normal-weight pregnant women
- 24-40 gestational week
Who cannot join
- Twin pregnancies, structural and chromosomal abnormalities, fetal rhesus isoimmunization, fetal growth restriction, cases with infections detected by maternal serological tests, pregestational or gestational diabetes (All patients underwent a 75-gram glucose load test at 24 weeks to rule out diabetes), preeclampsia, premature rupture of membranes were excluded from the study -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Myocardial Performance Index and Fetal Epicardial Thickness on Perinatal Outcomes in Obese Pregnant Women
the effects of fetal EFT on fetal cardiac function and fetal and maternal outcomes were investigated in obese pregnant women compared with normal-weight pregnant women.
Read the detailed description
All pregnant women underwent a comprehensive fetal anomaly screening. One obstetrician (S.D.) assessed all of the measurements. Every measurement was performed using a convex 2-5 MHz Voluson E8 probe (GE Healthcare, Milwaukee, WI). Fetal biometry, UA, MCA Doppler, cerebroplacental ratio (CPR), modified MPI (mod-MPI), and EFT were assessed in accordance with the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) guidelines
- Conditions
- Fetus Fetus, Pregnancy Complications
- Being tested
- Doppler ultrasonography
- Keywords
- obesity,, fetal epicardial thickness, myocardial performance index, perinatal outcome
- Medical subject headings
- Fetus-in-Fetu, Pregnancy Complications, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasonographyDiagnostic test
Doppler study was performed in all cases. perinatal outcomes were evaluated.
| Study group | Role | What they receive |
|---|---|---|
| myocardial performance and epicard thickness in obese pregnant women | Active comparator | obese pregnant versus normal-weight pregnant women were evaluated for MPI and fetal epicardial thickness Receives: Diagnostic Test: Doppler ultrasonography |
| obese pregnant | Active comparator | obese pregnant versus normal-weight pregnant women were evaluated for MPI and fetal epicardial thickness Receives: Diagnostic Test: Doppler ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
birth weight (gram)
fetal outcome
Measured: birth 1 week
stillbirth rate (%)
fetal outcome
Measured: birth 1 week
NICU admission
fetal outcome
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start1 Oct 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fetus FetusStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- case control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 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
- Investigators
- şükran DR doğru, md, Study director, NECMETTİN ERBAKAN UNIVERCITYfatih dr akkuş, md, Principal investigator, NECMETTİN ERBAKAN UNIVERCITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948319
- Sponsor's protocol ID
- 14221/neu
- Acronym
- EFT
- Status last verified
- Jul 2023
- First submitted
- 27 May 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: provided by the responsible researgher if requested
Publications
Dogru S, Akkus F, Metin US, Acar A. Fetal Epicardial Fat Thickness in Obese Pregnant Women: Its Effect on Fetal Cardiac Function and Neonatal Outcomes. Z Geburtshilfe Neonatol. 2024 Oct;228(5):439-445. doi: 10.1055/a-2267-5478. Epub 2024 Mar 19.
PubMed 38503305
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Myocardial Performance Index and Fetal Epicardial Thickness on Perinatal Outcomes in Obese Pregnant Women
- ClinicalTrials.gov ID
- NCT05948319
- Acronym / sponsor ID
- EFT / 14221/neu
- Conditions
- Fetus Fetus, Pregnancy Complications
- Keywords
- obesity,, fetal epicardial thickness, myocardial performance index, perinatal outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 17 Jul 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.
the effects of fetal EFT on fetal cardiac function and fetal and maternal outcomes were investigated in obese pregnant women compared with normal-weight pregnant women.
Detailed description
All pregnant women underwent a comprehensive fetal anomaly screening. One obstetrician (S.D.) assessed all of the measurements. Every measurement was performed using a convex 2-5 MHz Voluson E8 probe (GE Healthcare, Milwaukee, WI). Fetal biometry, UA, MCA Doppler, cerebroplacental ratio (CPR), modified MPI (mod-MPI), and EFT were assessed in accordance with the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) guidelines
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- case control
| Arm | Type | Receives |
|---|---|---|
| myocardial performance and epicard thickness in obese pregnant women | Active comparator | Diagnostic Test: Doppler ultrasonographyobese pregnant versus normal-weight pregnant women were evaluated for MPI and fetal epicardial thickness |
| obese pregnant | Active comparator | Diagnostic Test: Doppler ultrasonographyobese pregnant versus normal-weight pregnant women were evaluated for MPI and fetal epicardial thickness |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Obese pregnant women
- normal-weight pregnant women
- 24-40 gestational week
Key exclusion criteria (1 listed)
- Twin pregnancies, structural and chromosomal abnormalities, fetal rhesus isoimmunization, fetal growth restriction, cases with infections detected by maternal serological tests, pregestational or gestational diabetes (All patients underwent a 75-gram glucose load test at 24 weeks to rule out diabetes), preeclampsia, premature rupture of membranes were excluded from the study -
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 |
|---|---|---|
| Doppler ultrasonographyDoppler study was performed in all cases. perinatal outcomes were evaluated. | Diagnostic test | myocardial performance and epicard thickness in obese pregnant women, obese pregnant |
Primary outcome
birth weight (gram)
Time frame: birth 1 week
fetal outcome
stillbirth rate (%)
Time frame: birth 1 week
fetal outcome
NICU admission
Time frame: 6 months
fetal outcome
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 17 Jul 2023.
- Derived from this study: PubMed 38503305Dogru S, Akkus F, Metin US, Acar A. Fetal Epicardial Fat Thickness in Obese Pregnant Women: Its Effect on Fetal Cardiac Function and Neonatal Outcomes. Z Geburtshilfe Neonatol. 2024 Oct;228(5):439-445. doi: 10.1055/a-2267-5478. Epub 2024 Mar 19.
- Individual participant dataSharing planned: Yes. provided by the responsible researgher if requested
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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.
şükran DR doğru, md study director
NECMETTİN ERBAKAN UNIVERCITY
fatih dr akkuş, md principal investigator
NECMETTİN ERBAKAN UNIVERCITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doppler ultrasonography in people with Fetus Fetus and Pregnancy Complications, 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?
The sponsor lists 3 inclusion and 1 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 17 Jul 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. 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?
birth weight (gram) (time frame: birth 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05948319, which also lists 1 linked publication.
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 17 Jul 2023.