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the Fetal Epicardial Thickness in Obese Pregnant Women (EFT)

Sponsor
Necmettin Erbakan University (Other)
Overall Status
Completed
CT.gov ID
NCT05948319
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
6.9
Actual Duration (Months)
17.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Doppler ultrasonography
 N/A

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

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
case controlcase control
Masking:
Single (Participant)
Masking Description:
obese and non obese pregnant women
Primary Purpose:
Screening
Official Title:
The Effect of Myocardial Performance Index and Fetal Epicardial Thickness on Perinatal Outcomes in Obese Pregnant Women
Actual Study Start Date :
Oct 1, 2022
Actual Primary Completion Date :
Apr 30, 2023
Actual Study Completion Date :
Apr 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: myocardial performance and epicard thickness in obese pregnant women

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

Diagnostic Test: Doppler ultrasonography
Doppler study was performed in all cases. perinatal outcomes were evaluated.
Active Comparator: obese pregnant

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

Diagnostic Test: Doppler ultrasonography
Doppler study was performed in all cases. perinatal outcomes were evaluated.

Outcome Measures

Primary Outcome Measures

  1. birth weight (gram) [birth 1 week]

    fetal outcome

  2. stillbirth rate (%) [birth 1 week]

    fetal outcome

  3. NICU admission [6 months]

    fetal outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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 -

Contacts and Locations

Locations

Site City State Country Postal Code
1 Necmettin Erbakan University Konya Turkey 42140

Sponsors and Collaborators

  • Necmettin Erbakan University

Investigators

  • Study Director: şükran DR doğru, md, NECMETTİN ERBAKAN UNIVERCITY
  • Principal Investigator: fatih dr akkuş, md, NECMETTİN ERBAKAN UNIVERCITY

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
şükran doğru, medical director, Necmettin Erbakan University
ClinicalTrials.gov Identifier:
NCT05948319
Other Study ID Numbers:
  • 14221/neu
First Posted:
Jul 17, 2023
Last Update Posted:
Jul 17, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by şükran doğru, medical director, Necmettin Erbakan University
obesity,
fetal epicardial thickness
myocardial performance index
perinatal outcome
Additional relevant MeSH terms:
Pregnancy Complications

Study Results

No Results Posted as of Jul 17, 2023