NCT03822143

Brief Summary

The aim of this study is to diagnose anemia in fetuses through the use of ultrasound.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

February 15, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

January 28, 2019

Last Update Submit

February 13, 2019

Conditions

Anemia in Fetus

Outcome Measures

Primary Outcomes (1)

  • Anemia diagnosis in fetus

    Data collection from use of ultrasound will be analyzed through a laboratory algorithm to determine whether a fetus has anemia

    One week

Study Arms (1)

Fetus anemia diagnosis

EXPERIMENTAL

Diagnosis of anemia in the fetus through use of ultrasound data collection

Diagnostic Test: Ultrasound

Interventions

UltrasoundDIAGNOSTIC_TEST

Use of ultrasound device to diagnosis anemia in a fetus

Fetus anemia diagnosis

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women from 16th week to 41st week +6 days
  • Singleton fetus

You may not qualify if:

  • All others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hille Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Alon Shrim, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hadil Melhem, BA

CONTACT

972-54-8863143hadilm@hy.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2019

First Posted

January 30, 2019

Study Start

February 1, 2019

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

February 15, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)