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CompletedNCT03591640Updated Jun 28, 2022

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

An interventional study of Blood test in Fetal-Maternal Hemorrhage, sponsored by Hillel Yaffe Medical Center. Completed at 1 site in Israel. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-28.

Sponsored by Hillel Yaffe Medical Center · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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

02

Conditions studied

  • Fetal-Maternal Hemorrhage
03

In context

Hemoglobinopathies

105 studies on the registry are indexed under Hemoglobinopathies; 28 are open to participants now.

This study's enrollment of 27 is below the median of 31 across 67 interventional studies indexed under Hemoglobinopathies.

Browse Hemoglobinopathies studies →

Lead sponsor

Hillel Yaffe Medical Center is the lead sponsor of 301 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Known risk factor for fetal maternal hemorrhage
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Active comparator
    Pregnant with hemoglobinopathy

    Standard of care with blood test before active labor

    Diagnostic Test: Blood test

  • Active comparator
    Pregnant without known hemoglobinopathy

    Standard of care with blood test before active labor

    Diagnostic Test: Blood test

Interventions

  • Diagnostic testBlood test

    Standard blood test

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 hours

07

Study locations

1 site
  • Hille Yaffe Medical Center
    Hadera, 38100, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03591640
Lead sponsor
Hillel Yaffe Medical Center
Responsible party
Sponsor
First posted
Jul 19, 2018
Start date
Jul 18, 2018
Primary completion
Apr 28, 2021
Completion
Apr 28, 2021
Last update
Jun 28, 2022

Study contacts

Rinat Gabbay-Benziv, MD
principal investigator · Hillel Yaffe Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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