the Fetal Epicardial Thickness in Obese Pregnant Women (EFT)

NCT ID: NCT05948319

Last Updated: 2023-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-04-30

Brief Summary

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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

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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

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Fetus Fetus Pregnancy Complications

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

case control
Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants
obese and non obese pregnant women

Study Groups

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myocardial performance and epicard thickness in obese pregnant women

obese pregnant versus normal-weight pregnant women were evaluated for MPI and fetal epicardial thickness

Group Type ACTIVE_COMPARATOR

Doppler ultrasonography

Intervention Type DIAGNOSTIC_TEST

Doppler study was performed in all cases. perinatal outcomes were evaluated.

obese pregnant

obese pregnant versus normal-weight pregnant women were evaluated for MPI and fetal epicardial thickness

Group Type ACTIVE_COMPARATOR

Doppler ultrasonography

Intervention Type DIAGNOSTIC_TEST

Doppler study was performed in all cases. perinatal outcomes were evaluated.

Interventions

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Doppler ultrasonography

Doppler study was performed in all cases. perinatal outcomes were evaluated.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Obese pregnant women
* normal-weight pregnant women
* 24-40 gestational week

Exclusion Criteria

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 -
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Necmettin Erbakan University

OTHER

Sponsor Role lead

Responsible Party

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şükran doğru

medical director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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şükran DR doğru, md

Role: STUDY_DIRECTOR

NECMETTİN ERBAKAN UNIVERCITY

fatih dr akkuş, md

Role: PRINCIPAL_INVESTIGATOR

NECMETTİN ERBAKAN UNIVERCITY

Locations

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Necmettin Erbakan University

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 38503305 (View on PubMed)

Other Identifiers

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14221/neu

Identifier Type: -

Identifier Source: org_study_id

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