Clinical trial

Genotyping of Human Platelet Alloantigens : Non-invasive Prenatal Diagnosis

Name
2012-55
Description
Neonatal thrombocytopenia isoimmunization maternal-fetal is related to maternal immunization against fetal platelet antigens with paternal origin not present in the mother. It is considered the equivalent of hemolytic disease of the newborn. The incidence of this disease is about 1 in 800-1000 births. The most severe forms associated petechiae, purpura or cephalhematoma at birth with a major risk of cerebral hemorrhages (20% to 25% of cases) can cause the death of the child (15%) or severe neurological troubles (15-30%) Biologic diagnosis requires the detection of anti-platelet antibodies with maternal determination of platelet phenotypes and genotypes of the two parents. The objective of this work is to develop specific molecular tools to fetal platelet genotyping from maternal blood. We are particularly interested to antigens HPA-1, HPA-5 , HPA-3 and HPA-4. We evaluate the sensitivity and specificity of this test by comparing these results with those obtained from an invasive sampling of amniotic fluid. This is a prospective study to assess the technical and diagnostic performance of a new molecular method noninvasive prenatal diagnosis of platelet genotyping.
Trial arms
Trial start
2023-07-27
Estimated PCD
2023-07-27
Trial end
2023-07-27
Status
Withdrawn
Treatment
Extra blood draw samples
NEVER STARTED
Arms:
Pregnant women
extra amniotic fluid samples
NEVER STARTED
Arms:
Pregnant women
Primary endpoint
number of Fetomaternal platelet incompatibilities detected
30 months
Eligibility criteria
Inclusion Criteria: * patients with known risk of platelet alloimmunization * patients for whom suspicion of fetal cerebral hemorrhage has been advanced on ultrasound or fetal MRI signs Exclusion Criteria: * Twin pregnancy or triple
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2023-07-28

1 organization

2 products

1 indication