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Large study tracks antibody risk in pregnant women to prevent newborn bleeding

NCT ID NCT05345561

Knowledge-focused Sponsor: Rallybio Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed over 14,000 pregnant women to see how many are at risk for a condition called FNAIT, where a mother's immune system attacks her baby's platelets, causing dangerous bleeding. Researchers measured how often women develop specific antibodies (HPA-1a) and looked at pregnancy outcomes. No treatments were given; the goal was simply to gather information to better understand who is at risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

14,390 people

The number who actually took part.

Started

Mar 2022

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pregnant women (≥ 18 years of age) who have provided informed consent for the study. Exclusion Criteria: * Participants with prior history of FNAIT

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Conditions

The condition(s) this trial relates to.

fetal and neonatal alloimmune thrombocytopenia neonatal thrombocytopenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fetal and neonatal alloimmune thrombocytopenia

Contacts and locations

Locations

  • Barnmorskestationen Rosengård

    Lund, Skåne County, 222 42, Sweden

  • Clinical Trial Consultants - Uppsala

    Uppsala, Uppsala Ian, 752 37, Sweden

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Cooper University Hospital

    Camden, New Jersey, 08103, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Javara Inc. - Forest

    Dallas, Texas, 75230, United States

  • Javara Research Inc. - Dallas - PPDS

    Houston, Texas, 77054, United States

  • Klinikum der Friedrich Schiller Universität Jena

    Jena, Thuringia, 07747, Germany

  • Leids Universitair Medisch Centrum

    Leiden, South Holland, 2333 ZA, Netherlands

  • New Horizons Clinical Trials, LLC

    Chandler, Arizona, 85224, United States

  • New York-Presbyterian-Queens

    New York, New York, 10065, United States

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • Oslo Universitetssykehus HF, Ullevål

    Oslo, Oslo, 0524, Norway

  • Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901, United States

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103, United States

  • St. Peter's University Hospital

    New Brunswick, New Jersey, 08901, United States

  • St. Thomas' Hospital

    London, Surrey, SE1 7EH, United Kingdom

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • Södersjukhuset

    Stockholm, Stockholms Ian, 118 83, Sweden

  • Temple Perinatal Diagnosis Center

    Philadelphia, Pennsylvania, 19140, United States

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • Universitetssykehuset Nord Norge

    Tromsø, NO-9019, Norway

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • Weill Cornell Medicine-New York Presbyterian Hospital

    New York, New York, 10065, United States

  • Wright State Physicians Obstetrics & Gynecology

    Dayton, Ohio, 45409, United States

  • Yale University School of Medicine

    New Haven, Connecticut, 06511, United States

  • Zillan Clinical Research - Gardena

    Gardena, California, 90247, United States

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