NCT03591640

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

July 18, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2021

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

2.8 years

First QC Date

July 9, 2018

Last Update Submit

June 22, 2022

Conditions

Fetal-Maternal Hemorrhage

Outcome Measures

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

    24 hours

Study Arms (2)

Pregnant with hemoglobinopathy

ACTIVE COMPARATOR

Standard of care with blood test before active labor

Diagnostic Test: Blood test

Pregnant without known hemoglobinopathy

ACTIVE COMPARATOR

Standard of care with blood test before active labor

Diagnostic Test: Blood test

Interventions

Blood testDIAGNOSTIC_TEST

Standard blood test

Pregnant with hemoglobinopathyPregnant without known hemoglobinopathy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Known risk factor for fetal maternal hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hille Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Fetomaternal Transfusion

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Anemia, NeonatalAnemiaHematologic DiseasesHemic and Lymphatic DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Rinat Gabbay-Benziv, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2018

First Posted

July 19, 2018

Study Start

July 18, 2018

Primary Completion

April 28, 2021

Study Completion

April 28, 2021

Last Updated

June 28, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)