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Towards Routine HPA-screening In Pregnancy to Prevent FNAIT

NCT04067375 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3660

Last updated 2020-09-02

No results posted yet for this study

Summary

Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) is the most common cause of severe thrombocytopenia in otherwise healthy born neonates. FNAIT results in a risk of bleeding the most severe complication being intracranial haemorraghes (ICH). Bleedings can be prevented by effective antental treatment. In the absence of screening programs this treatment is too late to prevent the first affected child. The investigators aim to identify the pregnancies at risk and describe the incidence and natural course of this disease. In this way fetuses at risk can be identified in the future and timely antenatal treatment can be initiated.

Conditions

  • Fetal and Neonatal Alloimmune Thrombocytopenia

Interventions

OTHER

Clinical data collection.

The following clinical data will be collected; maternal baseline characteristics, delivery related data, neonatal outcome, neonatal bleeding signs.

Sponsors & Collaborators

  • Sanquin Research & Blood Bank Divisions

    collaborator OTHER

  • Landsteiner Foundation for Blood Transfusion

    collaborator OTHER

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Dick Oepkes, Prof MD PhD · Department of Obstetrics, Leiden University Medical Centre, Leiden

  • Masja de Haas, Prof MD PhD · Department of Immunohematology Diagnostics, Sanquin Diagnostics, Amsterdam

  • Ellen vd Schoot, Prof MD PhD · Department of Experimental Immunohematology, Sanquin Reseach, Amsterdam

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2020-04-01
Completion
2020-04-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04067375 on ClinicalTrials.gov