NCT05737043

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 22, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

February 12, 2023

Last Update Submit

February 12, 2023

Conditions

Fetal DiagnoseFetal Cardiac Disorder

Keywords

polyhidramnios, epicard, myocardial performance index

Outcome Measures

Primary Outcomes (1)

  • neonatal and fetal outcome

    Do epicardial thickness and myocardial performance index determine fetal outcome in cases with polyhdramnios?

    1 year

Study Arms (2)

myocardial performance and epicard thickness in case with polyhidramnios

PLACEBO COMPARATOR

we will do a fetal echo, and fetal screening with ultrasonography

Diagnostic Test: prenatal diagnose

pregnant women with polyhidramios

ACTIVE COMPARATOR
Diagnostic Test: prenatal diagnose

Interventions

prenatal diagnoseDIAGNOSTIC_TEST

we will do a fetal echo in pregnant women with polyhidramnios

myocardial performance and epicard thickness in case with polyhidramniospregnant women with polyhidramios

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, 42140, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
md

Study Record Dates

First Submitted

February 12, 2023

First Posted

February 21, 2023

Study Start

July 22, 2022

Primary Completion

February 12, 2023

Study Completion

February 12, 2023

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations

TU(1)