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NCT02899598

Genotyping of Human Platelet Alloantigens : Non-invasive Prenatal Diagnosis

Withdrawn NA Last updated 28 July 2023
What this trial tests

NA trial testing Extra blood draw samples in Neonatal Thrombocytopenia Isoimmunization Maternal-fetal. Withdrawn.

Timeline
27 July 2023
Primary endpoint
27 July 2023
27 July 2023

Quick facts

Lead sponsorAssistance Publique Hopitaux De Marseille
PhaseNA
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Start date27 July 2023
Primary completion27 July 2023
Estimated completion27 July 2023
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Assistance Publique Hopitaux De Marseille — full company profile →

Who can join

18 and older, female only, with Neonatal Thrombocytopenia Isoimmunization Maternal-fetal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Extra blood draw samples

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Other Assistance Publique Hopitaux De Marseille trials

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Data sources for this page

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