Fetal-Maternal HemorrhageNCT03591640
The Validity of Kleinhauer Betke in Women With Known Hemoglobinopathy for Fetal-maternal Hemorrhage
A study testing Blood test in people with Fetal-Maternal Hemorrhage, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to determine the validity of Kleinhauer Betke in women with known hemoglobinopathy for fetal-maternal hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal-Maternal Hemorrhage
- What is being tested?
- Blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Jul 2018to 28 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant with singleton fetus
- Gestational age 34-42
- With or without known hemoglobinopathy
Who cannot join
- Known risk factor for fetal maternal hemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine the validity of Kleinhauer Betke in women with known hemoglobinopathy for fetal-maternal hemorrhage.
- Conditions
- Fetal-Maternal Hemorrhage
- Being tested
- Blood test
- Medical subject headings
- Fetomaternal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testDiagnostic test
Standard blood test
| Study group | Role | What they receive |
|---|---|---|
| Pregnant with hemoglobinopathy | Active comparator | Standard of care with blood test before active labor Receives: Diagnostic Test: Blood test |
| Pregnant without known hemoglobinopathy | Active comparator | Standard of care with blood test before active labor Receives: Diagnostic Test: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start18 Jul 2018
- Primary completion28 Apr 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal-Maternal HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Rinat Gabbay-Benziv, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591640
- Sponsor's protocol ID
- HYMC-0057-18
- Status last verified
- Jun 2022
- First submitted
- 9 Jul 2018
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity of Kleinhauer Betke in Women With Known Hemoglobinopathy for Fetal-maternal Hemorrhage
- ClinicalTrials.gov ID
- NCT03591640
- Acronym / sponsor ID
- HYMC-0057-18
- Conditions
- Fetal-Maternal Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the validity of Kleinhauer Betke in women with known hemoglobinopathy for fetal-maternal hemorrhage.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant with hemoglobinopathy | Active comparator | Diagnostic Test: Blood testStandard of care with blood test before active labor |
| Pregnant without known hemoglobinopathy | Active comparator | Diagnostic Test: Blood testStandard of care with blood test before active labor |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant with singleton fetus
- Gestational age 34-42
- With or without known hemoglobinopathy
Key exclusion criteria (1 listed)
- Known risk factor for fetal maternal hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testStandard blood test | Diagnostic test | Pregnant with hemoglobinopathy, Pregnant without known hemoglobinopathy |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Fetal-Maternal Hemorrhage
Not yet recruitingObservational study
Application of Quantitative Hemorrhage Detection in Fetomaternal Hemorrhage Syndrome for the Diagnosis of Hemolytic Disease of the Newborn
Hemolytic Disease of the Newborn
RecruitingObservational study
Maternal-fetal Outcomes of Genital Blood Loss Beyond 18 Weeks of Pregnancy
Blood Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rinat Gabbay-Benziv, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test in people with Fetal-Maternal Hemorrhage, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of Kleinhauer Betke test in Pregnant Women (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.