Towards Routine HPA-screening In Pregnancy to Prevent FNAIT

NCT04067375 | Completed

• 1 other identifier: P16.002
• Study Type: observational
• Target: 3,660
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Clinical relevant FNAIT

  Incidence of HPA-1a mediated FNAIT. defined as severe or mild FNAIT Severe: Intracranial haemorrhage or Internal organ haemorrhage Mild: petechiae, hematoma, purpura or mucosal bleeding.Thrombocytopenia for platelet transfusion, IVIg or clinical observation.

  Within 7 days after birth.

Secondary Outcomes (3)

• Neonatal thrombocytopenia

  Within 7 days after birth.

• Neonatal infection

  Within 7 days after birth.

• Chromosomal abnormality

  Within 7 days after birth.

Other Outcomes (8)

• Maternal age

  Measured at 27 weeks gestational age of current pregnancy.

• Number of participatnts with idiopathic thrombocytopenic purpura

  At inclusion

• Spontaneous miscarriage in obstetric history

  At inclusion

Study Arms (3)

Pregnant women, HPA-1a positive

RhD or Rhc negative women, identified through prenatal screening for red cell alloimmunization, that are typed as HPA-1a positive.

Other: Clinical data collection.

Pregnant women, HPA-1a negative with HPA-1a alloantibodies

RhD or Rhc negative women, identified through prenatal screening for red cell alloimmunization, that are typed as HPA-1a negative and have formed anti-HPA-1a alloantibodies.

Other: Clinical data collection.

Pregnant women, HPA-1a negative without HPA-1a alloantibodies

RhD or Rhc negative women, identified through prenatal screening for red cell alloimmunization, that are typed as HPA-1a negative and did not have formed anti-HPA-1a alloantibodies.

Other: Clinical data collection.

Interventions

Clinical data collection. OTHER

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

Pregnant women, HPA-1a negative with HPA-1a alloantibodies; Pregnant women, HPA-1a negative without HPA-1a alloantibodies; Pregnant women, HPA-1a positive

Eligibility Criteria

• Gender Eligibility Details: Pregnant women.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women.

You may qualify if:

• All pregnant women, of whom routine blood samples are taken at 27 weeks gestational age (GA).

You may not qualify if:

• \[ WILSONBEKWAAM EXCLUSIE\]

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Sanquin Research & Blood Bank Divisions: collaborator
• Landsteiner Foundation for Blood Transfusion: collaborator

Study Sites (1)

Stichting Bloedbank Sanquin

Amsterdam, 1066 CX, Netherlands

Location

Related Publications (2)

• de Vos TW, Winkelhorst D, Porcelijn L, Beaufort M, Oldert G, van der Bom JG, Lopriore E, Oepkes D, de Haas M, van der Schoot E. Natural history of human platelet antigen 1a-alloimmunised pregnancies: a prospective observational cohort study. Lancet Haematol. 2023 Dec;10(12):e985-e993. doi: 10.1016/S2352-3026(23)00271-5. Epub 2023 Oct 27.

  PMID: 38407610 DERIVED

• Winkelhorst D, de Vos TW, Kamphuis MM, Porcelijn L, Lopriore E, Oepkes D, van der Schoot CE, de Haas M. HIP (HPA-screening in pregnancy) study: protocol of a nationwide, prospective and observational study to assess incidence and natural history of fetal/neonatal alloimmune thrombocytopenia and identifying pregnancies at risk. BMJ Open. 2020 Jul 20;10(7):e034071. doi: 10.1136/bmjopen-2019-034071.

  PMID: 32690731 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Via a nationwide routine screening during pregnancy EDTA anticoagulated blood samples will be collected. Plasma and buffy coat will be stored. On plasma the following analysis will be performed: * HPA-1a typing by a new developed protol making use of ELISA. * Antibody screening by the Luminex assay. * Surface Plasmon Resonance on a sensor chip. To identify high risk cases fucosylation level of the antibodies will be performed. In addition to this the binding and functional effects to endothelial cells will be assessed.

MeSH Terms

Conditions

Thrombocytopenia, Neonatal Alloimmune

Condition Hierarchy (Ancestors)

Thrombocytopenia; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Dick Oepkes, Prof MD PhD

  Department of Obstetrics, Leiden University Medical Centre, Leiden

  STUDY DIRECTOR

• Masja de Haas, Prof MD PhD

  Department of Immunohematology Diagnostics, Sanquin Diagnostics, Amsterdam

  STUDY DIRECTOR

• Ellen vd Schoot, Prof MD PhD

  Department of Experimental Immunohematology, Sanquin Reseach, Amsterdam

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Fetal Therapy. Head of the section Fetal Medicine.

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: August 26, 2019
• Study Start: March 1, 2017
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)