the Fetal Epicardial Thickness in Obese Pregnant Women (EFT)

NCT05948319 | Completed

• 1 other identifier: 14221/neu
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fetus Fetus; Pregnancy Complications

Keywords

obesity,; fetal epicardial thickness; myocardial performance index; perinatal outcome

Outcome Measures

Primary Outcomes (3)

• birth weight (gram)

  fetal outcome

  birth 1 week

• stillbirth rate (%)

  fetal outcome

  birth 1 week

• NICU admission

  fetal outcome

  6 months

Study Arms (2)

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

Diagnostic Test: Doppler ultrasonography

obese pregnant

ACTIVE COMPARATOR

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

Diagnostic Test: Doppler ultrasonography

Interventions

Doppler ultrasonography DIAGNOSTIC_TEST

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

myocardial performance and epicard thickness in obese pregnant women; obese pregnant

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Obese pregnant women
• normal-weight pregnant women
• gestational week

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University

Konya, 42140, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 38503305 DERIVED

MeSH Terms

Conditions

Fetus-in-Fetu; Pregnancy Complications; Obesity

Interventions

Ultrasonography, Doppler

Condition Hierarchy (Ancestors)

Twins, Conjoined; Abnormalities, Severe Teratoid; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• şükran DR doğru, md

  NECMETTİN ERBAKAN UNIVERCITY

  STUDY DIRECTOR

• fatih dr akkuş, md

  NECMETTİN ERBAKAN UNIVERCITY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: obese and non obese pregnant women
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical director

Model Details: case control

Study Record Dates

• First Submitted: May 27, 2023
• First Posted: July 17, 2023
• Study Start: October 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 2 MONTHS
• Access Criteria: VİA MAİL ADDRESS

Locations

TU (1)