Back to resultsFetus Anemia Diagnosis by Ultrasound Data Collection
Primary Purpose
Anemia in Fetus
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Anemia in Fetus
Eligibility Criteria
Inclusion Criteria:
- Pregnant women from 16th week to 41st week +6 days
- Singleton fetus
Exclusion Criteria:
- All others
Sites / Locations
- Hille Yaffe Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fetus anemia diagnosis
Arm Description
Diagnosis of anemia in the fetus through use of ultrasound data collection
Outcomes
Primary Outcome Measures
Anemia diagnosis in fetus
Data collection from use of ultrasound will be analyzed through a laboratory algorithm to determine whether a fetus has anemia
Secondary Outcome Measures
Full Information
NCT ID
NCT03822143
First Posted
January 28, 2019
Last Updated
February 13, 2019
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03822143
Brief Title
Fetus Anemia Diagnosis by Ultrasound Data Collection
Official Title
Fetus Anemia Diagnosis by Ultrasound Data Collection
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2019 (Anticipated)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to diagnose anemia in fetuses through the use of ultrasound.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia in Fetus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fetus anemia diagnosis
Arm Type
Experimental
Arm Description
Diagnosis of anemia in the fetus through use of ultrasound data collection
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound
Intervention Description
Use of ultrasound device to diagnosis anemia in a fetus
Primary Outcome Measure Information:
Title
Anemia diagnosis in fetus
Description
Data collection from use of ultrasound will be analyzed through a laboratory algorithm to determine whether a fetus has anemia
Time Frame
One week
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant women from 16th week to 41st week +6 days
Singleton fetus
Exclusion Criteria:
All others
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hadil Melhem, BA
Phone
972-54-8863143
Email
hadilm@hy.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alon Shrim, MD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hille Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hadil Melhem, BA
Phone
972-54-8863143
Email
hadilm@hy.health.gov.il
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fetus Anemia Diagnosis by Ultrasound Data Collection
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