the Fetal Epicardial Thickness in Obese Pregnant Women (EFT)

Not Applicable

Completed

• Conditions: Pregnancy Complications; Fetus Fetus
• Interventions: Diagnostic Test: Doppler ultrasonography

• Registration Number: NCT05948319
• Lead Sponsor: Necmettin Erbakan University

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.

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 Timeline

• Study Start: 2022-10-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Study First Submitted: 2023-05-27
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-14
• Last Update Submitted: 2023-07-14
• Study First Posted: 2023-07-17
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
myocardial performance and epicard thickness in obese pregnant women	Doppler ultrasonography	obese pregnant versus normal-weight pregnant women were evaluated for MPI and fetal epicardial thickness
obese pregnant	Doppler ultrasonography	obese pregnant versus normal-weight pregnant women were evaluated for MPI and fetal epicardial thickness

Primary Outcome Measures

Name	Time	Method
birth weight (gram)	birth 1 week	fetal outcome
stillbirth rate (%)	birth 1 week	fetal outcome
NICU admission	6 months	fetal outcome

Trial Locations

Locations (1)

Necmettin Erbakan University; 🇹🇷 Konya, Turkey