Back to resultsthe Fetal Epicardial Thickness in Obese Pregnant Women (EFT) (EFT)
Primary Purpose
Fetus Fetus, Pregnancy Complications
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Doppler ultrasonography
Sponsored by
About this trial
This is an interventional screening trial for Fetus Fetus focused on measuring obesity,, fetal epicardial thickness, myocardial performance index, perinatal outcome
Eligibility Criteria
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 -
Sites / Locations
- Necmettin Erbakan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
myocardial performance and epicard thickness in obese pregnant women
obese pregnant
Arm Description
obese pregnant versus normal-weight pregnant women were evaluated for MPI and fetal epicardial thickness
obese pregnant versus normal-weight pregnant women were evaluated for MPI and fetal epicardial thickness
Outcomes
Primary Outcome Measures
birth weight (gram)
fetal outcome
stillbirth rate (%)
fetal outcome
NICU admission
fetal outcome
Secondary Outcome Measures
Full Information
NCT ID
NCT05948319
First Posted
May 27, 2023
Last Updated
July 14, 2023
Sponsor
Necmettin Erbakan University
1. Study Identification
Unique Protocol Identification Number
NCT05948319
Brief Title
the Fetal Epicardial Thickness in Obese Pregnant Women (EFT)
Acronym
EFT
Official Title
The Effect of Myocardial Performance Index and Fetal Epicardial Thickness on Perinatal Outcomes in Obese Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Necmettin Erbakan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetus Fetus, Pregnancy Complications
Keywords
obesity,, fetal epicardial thickness, myocardial performance index, perinatal outcome
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
case control
Masking
Participant
Masking Description
obese and non obese pregnant women
Allocation
Non-Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
myocardial performance and epicard thickness in obese pregnant women
Arm Type
Active Comparator
Arm Description
obese pregnant versus normal-weight pregnant women were evaluated for MPI and fetal epicardial thickness
Arm Title
obese pregnant
Arm Type
Active Comparator
Arm Description
obese pregnant versus normal-weight pregnant women were evaluated for MPI and fetal epicardial thickness
Intervention Type
Diagnostic Test
Intervention Name(s)
Doppler ultrasonography
Intervention Description
Doppler study was performed in all cases. perinatal outcomes were evaluated.
Primary Outcome Measure Information:
Title
birth weight (gram)
Description
fetal outcome
Time Frame
birth 1 week
Title
stillbirth rate (%)
Description
fetal outcome
Time Frame
birth 1 week
Title
NICU admission
Description
fetal outcome
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
şükran DR doğru, md
Organizational Affiliation
NECMETTİN ERBAKAN UNIVERCITY
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
fatih dr akkuş, md
Organizational Affiliation
NECMETTİN ERBAKAN UNIVERCITY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Necmettin Erbakan University
City
Konya
ZIP/Postal Code
42140
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
provided by the responsible researgher if requested
IPD Sharing Time Frame
2 MONTHS
IPD Sharing Access Criteria
VİA MAİL ADDRESS
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the Fetal Epicardial Thickness in Obese Pregnant Women (EFT)
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