Modified Myocardial Performance Index and Epicardial Thickness in Cases With Idiopathic Polyhydramnios

Comparison of the Modified Myocardial Performance Index and Epicardial Thickness in Cases With Idiopathic Polyhydramnios and in Healthy Normal Pregnancies

In cases diagnosed as idiopathic polyhydramnios and healthy pregnancy between 24-40 weeks (total number of cases (100-120)), prospective fetal echocardiography will be performed to evaluate MPI and EFT.

Study Overview

• Status: Completed
• Conditions: Fetal Cardiac Disorder; Fetal Diagnose
• Intervention / Treatment: Diagnostic test: prenatal diagnose

Detailed Description

: gestational week, maternal age, amniotic fluid index measurement, modified myocardial performance in fetal echo and epicardial thickness of all cases will be evaluated. week of pregnancy, body mass index, fetal biometry, umbilical artery doppler, middle cerebral artery doppler measurements will be taken. Birth weight and fetal intensive care hospitalizations at the birth week of all cases will be recorded. All data will be evaluated with the appropriate statistical method.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey, 42140
    • Necmettin Erbakan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria: 24-40 weeks gestational age, polyhydramnios and healthy pregnancy -

Exclusion Criteria: multıpl pregnancy, fetal anomaly, growth restriction, maternal chronic disease

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: myocardial performance and epicard thickness in case with polyhidramnios; we will do a fetal echo, and fetal screening with ultrasonography	Diagnostic test: prenatal diagnose; we will do a fetal echo in pregnant women with polyhidramnios
Active Comparator: pregnant women with polyhidramios	Diagnostic test: prenatal diagnose; we will do a fetal echo in pregnant women with polyhidramnios

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neonatal and fetal outcome	Do epicardial thickness and myocardial performance index determine fetal outcome in cases with polyhdramnios?	1 year

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2022
• Primary Completion (Actual): February 12, 2023
• Study Completion (Actual): February 12, 2023

Study Registration Dates

• First Submitted: February 12, 2023
• First Submitted That Met QC Criteria: February 12, 2023
• First Posted (Estimate): February 21, 2023

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 12, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: polyhidramnios, epicard, myocardial performance index
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pregnancy Complications; Heart Diseases; Polyhydramnios
• Other Study ID Numbers: 2023/4145(10675: neu)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: I want to share it as an article when the results are collected

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No