NCT02899598

Brief Summary

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 Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
6.9 years until next milestone

Study Start

First participant enrolled

July 27, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2023

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

Same day

First QC Date

September 9, 2016

Last Update Submit

July 27, 2023

Conditions

Neonatal Thrombocytopenia Isoimmunization Maternal-fetal

Outcome Measures

Primary Outcomes (1)

  • number of Fetomaternal platelet incompatibilities detected

    30 months

Study Arms (1)

Pregnant women

EXPERIMENTAL
Biological: Extra blood draw samplesBiological: extra amniotic fluid samples

Interventions

Extra blood draw samplesBIOLOGICAL

NEVER STARTED

Pregnant women
extra amniotic fluid samplesBIOLOGICAL

NEVER STARTED

Pregnant women

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with known risk of platelet alloimmunization
  • patients for whom suspicion of fetal cerebral hemorrhage has been advanced on ultrasound or fetal MRI signs

You may not qualify if:

  • Twin pregnancy or triple

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13005, France

Location

Study Officials

  • Urielle Desalbres

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 14, 2016

Study Start

July 27, 2023

Primary Completion

July 27, 2023

Study Completion

July 27, 2023

Last Updated

July 28, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)