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

Fetal-Maternal Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03591640
• Other study ID #: HYMC-0057-18
• Status: Completed
• Phase: N/A
• Start date: July 18, 2018
• Est. completion date: April 28, 2021

Study information

• Verified date: June 2022
• Source: Hillel Yaffe Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 28, 2021
• Est. primary completion date: April 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant with singleton fetus
• Gestational age 34-42
• With or without known hemoglobinopathy

Exclusion Criteria:

• Known risk factor for fetal maternal hemorrhage

Related Conditions & MeSH terms

• Fetal-Maternal Hemorrhage
• Fetomaternal Transfusion
• Hemoglobinopathies
• Hemorrhage

Intervention

Diagnostic Test:
• Blood test
Standard blood test

Locations

Country	Name	City	State
Israel	Hille Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours