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The Validity of Kleinhauer Betke in Women With Known Hemoglobinopathy for Fetal-maternal Hemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03591640
Recruitment Status : Unknown
Verified July 2018 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Study Description
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Brief Summary:
The aim of this study is to determine the validity of Kleinhauer Betke in women with known hemoglobinopathy for fetal-maternal hemorrhage.

Condition or disease Intervention/treatment Phase
Fetal-Maternal Hemorrhage Diagnostic Test: Blood test Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Validity of Kleinhauer Betke in Women With Known Hemoglobinopathy for Fetal-maternal Hemorrhage
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Pregnant with hemoglobinopathy
Standard of care with blood test before active labor
 Diagnostic Test: Blood test
Standard blood test
Active Comparator: Pregnant without known hemoglobinopathy
Standard of care with blood test before active labor
 Diagnostic Test: Blood test
Standard blood test


Outcome Measures
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Primary Outcome Measures :
  1. Validity of Kleinhauer Betke test in Pregnant Women [ Time Frame: 24 hours ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591640


Contacts
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Contact: Genya Peisahov, BSc 972-54-8886349 genyap@hymc.gov.il

Locations
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Israel
Hille Yaffe Medical Center
Hadera, Israel, 38100
Contact: Genya Peisahov, BSc         
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
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Principal Investigator: Rinat Gabbay-Benziv, MD Hillel Yaffe Medical Center
More Information
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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT03591640    
Other Study ID Numbers: HYMC-0057-18
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemoglobinopathies
Fetomaternal Transfusion
Hemorrhage
Pathologic Processes
Hematologic Diseases
 Genetic Diseases, Inborn
Anemia, Neonatal
Anemia
Infant, Newborn, Diseases