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NCT07194070From ClinicalTrials.govRecruiting

A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry

Global Prospective Hemolytic Disease of the Fetus and Newborn Registry

  • Hemolytic Disease of the Fetus and Newborn

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
Janssen Research & Development, LLC
Enrolment target
175
Started
17 December 2025
Main results due
26 May 2030
Study sites
15
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Women only.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* Pregnant with an estimated gestational age (GA) (based on ultrasound dating) up to week 24
* History of a previous alloimmunized pregnancy that included at least one of the following: Fetal anemia diagnosed by middle cerebral artery (MCA) doppler ultrasound; Received greater than or equal to (\>=) 1 intrauterine transfusion (IUT) as a result of hemolytic disease of the fetus and newborn (HDFN); Fetal hydrops; Stillbirth or fetal demise with fetal or placental pathology indicative of HDFN; Neonatal exchange transfusion due to HDFN; Neonatal simple transfusion due to HDFN; Neonatal hyperbilirubinemia due to HDFN; Positive direct antiglobulin test (DAT) in neonate
* Documented presence of maternal alloantibody based on local laboratory results during current pregnancy
* Evidence of an antigen-positive fetus corresponding to the current maternal alloantibody: Fetal antigen status confirmed by cell-free fetal DNA (cffDNA); OR Fetal antigen status confirmed by amniocentesis; OR Paternal genotype confirmed
* Pregnant participant or a legally acceptable representative has provided informed consent (per local regulations or ethics committee requirements) for the collection and use of their medical data and the medical data for their corresponding fetuses/neonates/infants/children

Exclusion Criteria:

* Participant actively participating in an interventional trial of an investigational agent
* At risk for HDFN due to ABO being the sole alloimmunization antigen in the current pregnancy (that is, ABO plus another antigen is permissible)

What this study is about

In the sponsor’s own words, from the registry.

The purpose of this non-interventional study is to prospectively evaluate the risk of anemia (decreased red blood cells) in fetuses (baby before birth) and neonates (baby just after birth) of pregnant participants who are at risk for hemolytic disease of the fetus and newborn (HDFN) and receiving standard of care (SoC). HDFN is a blood disease that occurs in babies before birth or just after birth when the blood types of the pregnant individual and babies are incompatible, thus resulting in fast breakdown of red blood cells (RBCs) of the fetus/baby.

Study sites(15)

  • Riley Children s Hospital

    Indianapolis, Indiana, United States

    Suspended

  • University of Rochester Medical Center

    Rochester, New York, United States

    Recruiting

  • University of Cincinnati

    Cincinnati, Ohio, United States

    Recruiting

  • Oregon Health And Science University

    Portland, Oregon, United States

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, United States

    Recruiting

  • The Royal Women's Hospital

    Parkville, Australia

    Recruiting

  • Mater Misericordiae Ltd

    South Brisbane, Australia

    Recruiting

  • Universitair Ziekenhuis Gent

    Ghent, Belgium

    Recruiting

  • Universitair Ziekenhuis Leuven

    Leuven, Belgium

    Recruiting

  • State University of Campinas Joao Bennini

    Campinas, Brazil

    Recruiting

  • Interdiszip Schwerpunkt fur Hamostaseologie

    Giessen, Germany

    Recruiting

  • Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico

    Milan, Italy

    Recruiting

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, Italy

    Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, Spain

    Recruiting

  • Birmingham Women's Hospital

    Birmingham, United Kingdom

    Recruiting

Showing 15 of 15 sites. 14 of the 15 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07194070. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry | Trialion