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

March 4, 2026 updated by: Rallybio

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, 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

14390

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
  • Germany
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • Klinikum der Friedrich Schiller Universität Jena
  • Netherlands
    • South Holland
      • Leiden, South Holland, Netherlands, 2333 ZA
        • Leids Universitair Medisch Centrum
  • Norway
      • Tromsø, Norway, NO-9019
        • Universitetssykehuset Nord Norge
    • Oslo County
      • Oslo, Oslo County, Norway, 0524
        • Oslo Universitetssykehus HF, Ulleval
  • Sweden
    • Skåne County
      • Lund, Skåne County, Sweden, 222 42
        • Barnmorskestationen Rosengård
    • Stockholms Ian
      • Stockholm, Stockholms Ian, Sweden, 118 83
        • Södersjukhuset
    • Uppsala Ian
      • Uppsala, Uppsala Ian, Sweden, 752 37
        • Clinical Trial Consultants - Uppsala
  • United Kingdom
    • Surrey
      • London, Surrey, United Kingdom, SE1 7EH
        • St. Thomas' Hospital
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • New Horizons Clinical Trials, LLC
    • California
      • Gardena, California, United States, 90247
        • Zillan Clinical Research - Gardena
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale University School of Medicine
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson Medical School
      • New Brunswick, New Jersey, United States, 08901
        • St. Peter's University Hospital
      • Newark, New Jersey, United States, 07103
        • Rutgers New Jersey Medical School
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center
      • New York, New York, United States, 10065
        • New York-Presbyterian-Queens
      • New York, New York, United States, 10065
        • Weill Cornell Medicine-New York Presbyterian Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Wexner Medical Center
      • Dayton, Ohio, United States, 45409
        • Wright State Physicians Obstetrics & Gynecology
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple Perinatal Diagnosis Center
    • Texas
      • Dallas, Texas, United States, 75230
        • Javara Inc. - Forest
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston
      • Houston, Texas, United States, 77054
        • Javara Research Inc. - Dallas - PPDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pregnant women presenting at a Gestation Week 10 to 14 pre-natal visit

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Participants with prior history of FNAIT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant women
Women with higher risk of FNAIT
Other: Clinical data collection
Laboratory tests, Vital assessments, Maternal and fetal genotype testing, Antibodies Testing will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with higher FNAIT risk characterized by race and ethnicity
Time Frame: At inclusion
At inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of anti-HPA-1a maternal alloimmunization
Time Frame: At Week 10 postpartum or 10 weeks from the date of pregnancy terminating event
At Week 10 postpartum or 10 weeks from the date of pregnancy terminating event
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
At Week 10 postpartum or 10 weeks from the date of pregnancy terminating event
Occurrence of neonatal thrombocytopenia
Time Frame: At birth or at the time of the pregnancy terminating event
At birth or at the time of the pregnancy terminating event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rallybio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2022

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

October 10, 2025

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPA2002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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