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OpenTrials
Completed

NCT Number: NCT05345561

Study to Assess the Occurrence of HPA-1a Alloimmunization in Women With Higher Risk for Fetal and Neonatal Alloimmune Thrombocytopenia

A prospective, non-interventional, natural history study to assess the occurrence of higher FNAIT risk across a broad population of different racial and ethnic characteristics and the occurrence of HPA-1a alloimmunization in these women.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women (≥ 18 years of age) who have provided informed consent for the study.

Exclusion criteria

  • Participants with prior history of FNAIT

Treatment and study plan

Clinical data collection

Other

Laboratory tests, Vital assessments, Maternal and fetal genotype testing, Antibodies Testing will be performed.

Primary outcomes

  1. Number of participants with higher FNAIT risk characterized by race and ethnicity

    Time frame: At inclusion

Secondary outcomes

  1. Frequency of anti-HPA-1a maternal alloimmunization

    Time frame: At Week 10 postpartum or 10 weeks from the date of pregnancy terminating event

  2. Pregnancy outcomes: incidence of live births, spontaneous abortion, elective abortion, still birth, and premature birth

    Time frame: At Week 10 postpartum or 10 weeks from the date of pregnancy terminating event

  3. Occurrence of neonatal thrombocytopenia

    Time frame: At birth or at the time of the pregnancy terminating event

Sponsors and collaborators

Lead sponsor

Rallybio

Industry

Registry information

Official study title

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)

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 26, 2022
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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