Back to resultsThe Validity of Kleinhauer Betke in Women With Known Hemoglobinopathy for Fetal-maternal Hemorrhage
Primary Purpose
Fetal-Maternal Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Blood test
Sponsored by
About this trial
This is an interventional diagnostic trial for Fetal-Maternal Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- Pregnant with singleton fetus
- Gestational age 34-42
- With or without known hemoglobinopathy
Exclusion Criteria:
- Known risk factor for fetal maternal hemorrhage
Sites / Locations
- Hille Yaffe Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pregnant with hemoglobinopathy
Pregnant without known hemoglobinopathy
Arm Description
Standard of care with blood test before active labor
Standard of care with blood test before active labor
Outcomes
Primary Outcome Measures
Validity of Kleinhauer Betke test in Pregnant Women
Comparison of Kleinhauer Betke results with electrophoresis results to determine presence of F-hemoglobin. This would indicate the validity of the Kleinhauer Betke test in women with hemoglobinopathy
Secondary Outcome Measures
Full Information
NCT ID
NCT03591640
First Posted
July 9, 2018
Last Updated
June 22, 2022
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03591640
Brief Title
The Validity of Kleinhauer Betke in Women With Known Hemoglobinopathy for Fetal-maternal Hemorrhage
Official Title
The Validity of Kleinhauer Betke in Women With Known Hemoglobinopathy for Fetal-maternal Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 18, 2018 (Actual)
Primary Completion Date
April 28, 2021 (Actual)
Study Completion Date
April 28, 2021 (Actual)
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 determine the validity of Kleinhauer Betke in women with known hemoglobinopathy for fetal-maternal hemorrhage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal-Maternal Hemorrhage
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pregnant with hemoglobinopathy
Arm Type
Active Comparator
Arm Description
Standard of care with blood test before active labor
Arm Title
Pregnant without known hemoglobinopathy
Arm Type
Active Comparator
Arm Description
Standard of care with blood test before active labor
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood test
Intervention Description
Standard blood test
Primary Outcome Measure Information:
Title
Validity of Kleinhauer Betke test in Pregnant Women
Description
Comparison of Kleinhauer Betke results with electrophoresis results to determine presence of F-hemoglobin. This would indicate the validity of the Kleinhauer Betke test in women with hemoglobinopathy
Time Frame
24 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant with singleton fetus
Gestational age 34-42
With or without known hemoglobinopathy
Exclusion Criteria:
Known risk factor for fetal maternal hemorrhage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rinat Gabbay-Benziv, 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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Validity of Kleinhauer Betke in Women With Known Hemoglobinopathy for Fetal-maternal Hemorrhage
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