- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03591640
The Validity of Kleinhauer Betke in Women With Known Hemoglobinopathy for Fetal-maternal Hemorrhage
June 22, 2022 updated by: Hillel Yaffe Medical Center
The aim of this study is to determine the validity of Kleinhauer Betke in women with known hemoglobinopathy for fetal-maternal hemorrhage.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hadera, Israel, 38100
- Hille Yaffe medical center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Pregnant with singleton fetus
- Gestational age 34-42
- With or without known hemoglobinopathy
Exclusion Criteria:
- Known risk factor for fetal maternal hemorrhage
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pregnant with hemoglobinopathy
Standard of care with blood test before active labor
|
Standard blood test
|
Active Comparator: Pregnant without known hemoglobinopathy
Standard of care with blood test before active labor
|
Standard blood test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rinat Gabbay-Benziv, MD, Hillel Yaffe Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 18, 2018
Primary Completion (Actual)
April 28, 2021
Study Completion (Actual)
April 28, 2021
Study Registration Dates
First Submitted
July 9, 2018
First Submitted That Met QC Criteria
July 9, 2018
First Posted (Actual)
July 19, 2018
Study Record Updates
Last Update Posted (Actual)
June 28, 2022
Last Update Submitted That Met QC Criteria
June 22, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HYMC-0057-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fetal-Maternal Hemorrhage
-
Creighton UniversityRecruitingMaternal-Fetal Relations | Maternal BehaviorUnited States
-
KTO Karatay UniversityKAMİLE ALTUNTUĞRecruitingMaternal-Fetal Relations | Maternal BehaviorTurkey
-
Creighton UniversityRecruiting
-
Creighton UniversityJohn CoteCompletedMaternal-Fetal RelationsUnited States
-
Duzce UniversityCompleted
-
Heidemarie LaurentUniversity of Wisconsin, Madison; Mind and Life Institute, Hadley, MassachusettsRecruitingNeurobehavioral Effects of Prenatal Mindfulness Training on Maternal Presence and Compassionate LoveMaternal-Fetal Relations | Mother-Child Relations | Maternal BehaviorUnited States
-
Çankırı Karatekin UniversityNot yet recruitingMaternal-Fetal Relations
-
Obstetrix Medical GroupCompleted
-
Assiut UniversityCompletedMaternal-Fetal RelationsEgypt
-
Unity Health TorontoCompletedPregnancy | Epigenetics | Maternal Nutrition | Fetal Health | Maternal B VitaminsCanada
Clinical Trials on Blood test
-
French National Agency for Research on AIDS and...Completed
-
Pascual Gregori RoigHospital Universitario de la Plana; FUNDACIÓN DAVALOS FLETCHERCompletedHyperbilirubinemia, Neonatal | Anemia Neonatal | Polycythemia SecondarySpain
-
Wingate InstituteTel Aviv UniversityCompleted
-
University Hospital, ToursCompleted
-
Cairo UniversityUnknownClass III Malocclusion | Class II Malocclusion
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Imperial College LondonCompletedHereditary Hemorrhagic Telangiectasia | Pulmonary Arteriovenous MalformationsUnited Kingdom
-
Minovia Therapeutics Ltd.RecruitingMyelodysplastic SyndromesIsrael
-
Centre Hospitalier Universitaire de NīmesRecruitingNeoplasm Metastasis | Colorectal Cancer | Disseminated CancerFrance
-
University Hospital, GenevaHospices Civils de LyonNot yet recruitingAbuse, Child | Protein Disorder, BloodFrance, Switzerland