A prospective, natural history study to assess the occurrence of HPA-1a alloimmunization in women identified at higher risk for Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

A prospective, natural history study to assess the occurrence of HPA-1a alloimmunization in women identified at higher risk for Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) - FNAIT Natural History Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54467

Enrollment

2000

Registered

2022-03-25

Start date

2022-09-01

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood platelet shortage NAIT

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women (>= 18 years of age) who have provided informed consent for the study.

Exclusion criteria

Exclusion criteria: Prior history of FNAIT

Design outcomes

Primary

Measure	Time frame
Primary objective: To inform the frequency of women at higher FNAIT risk among pregnant women of different racial and ethnic characteristics who present for pre-natal care. Primary outcome: The number of participants that are determined to be at higher FNAIT risk compared to the total number of pregnant women assessed for higher FNAIT risk, with attention to self-characterized race and ethnicity.	—

Secondary

Measure	Time frame
Secondary objectives: * To inform the frequency of human platelet antigen (HPA)-1a alloimmunization among pregnant women identified at higher FNAIT risk. * To inform the frequency of pregnancy outcomes among pregnant women identified at higher FNAIT risk * To inform the frequency, where data are available, of neonatal thrombocytopenia in infants born to women who have alloimmunized, as determined by detectable anti-HPA-1a antibody at Week 10 postpartum Secondary outcomes: * Occurrence of anti-HPA-1a maternal alloimmunization at Week 10 postpartum * Rate of spontaneous abortion, defined as non-deliberate fetal death which occurs prior to 19 weeks of gestation • Rate of elective abortion, defined as deliberate termination of pregnancy at any time in gestation • Rate of still birth, defined as non-deliberate fetal death anytime in gestation on or after 19 weeks of gestation • Rate of premature delivery, defined as live birth prior to 37 completed weeks of gestation • Rate of live births (>= 37 completed weeks of gestation) * Neonatal thrombocytopenia, as determined by a platelet count	—

Measure

Time frame

Secondary objectives: * To inform the frequency of human platelet antigen (HPA)-1a alloimmunization among pregnant women identified at higher FNAIT risk. * To inform the frequency of pregnancy outcomes among pregnant women identified at higher FNAIT risk * To inform the frequency, where data are available, of neonatal thrombocytopenia in infants born to women who have alloimmunized, as determined by detectable anti-HPA-1a antibody at Week 10 postpartum Secondary outcomes: * Occurrence of anti-HPA-1a maternal alloimmunization at Week 10 postpartum * Rate of spontaneous abortion, defined as non-deliberate fetal death which occurs prior to 19 weeks of gestation • Rate of elective abortion, defined as deliberate termination of pregnancy at any time in gestation • Rate of still birth, defined as non-deliberate fetal death anytime in gestation on or after 19 weeks of gestation • Rate of premature delivery, defined as live birth prior to 37 completed weeks of gestation • Rate of live births (>= 37 completed weeks of gestation) * Neonatal thrombocytopenia, as determined by a platelet count

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Countries

Netherlands

Outcome results