Recruiting NCT07194070
A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard of Care.
- Who it may be relevant to
- Registry conditions: Hemolytic Disease of the Fetus and Newborn. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Belgium, Brazil, Germany +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Global Prospective Hemolytic Disease of the Fetus and Newborn Registry
Overview
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.
Interventions
- Other Standard of Care
No study treatment will be administered as part of this study. Participants will receive standard of care therapy as per local clinical practice.
Primary outcome measures
- Percentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death During the Neonatal Period [Time frame: From conception through 4 weeks of age or 41 weeks PMA, whichever is later]
Secondary outcome measures (4)
- Number of Participants With Hemolytic Disease of the Fetus and Newborn (HDFN) by Severity [Time frame: Through 4 weeks of age or 41 weeks PMA, whichever is later]
- Time to First Occurrence of IUT or Hydrops Fetalis [Time frame: From conception to delivery date (up to maximum of 42 weeks)]
- Modified Neonatal Morbidity and Mortality Index (mNMMI) in Live Newborn Neonates [Time frame: Through 38 weeks PMA or at discharge if earlier than 38 weeks PMA]
- Number of IUTs Received During the Pregnancy [Time frame: From conception to delivery date (up to maximum of 42 weeks)]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 5 centers
- Riley Children s Hospital — Indianapolis
- University of Rochester Medical Center — Rochester
- University of Cincinnati — Cincinnati
- Oregon Health And Science University — Portland
- Baylor College of Medicine — Houston
Australia · 2 centers
- The Royal Women's Hospital — Parkville
- Mater Misericordiae Ltd — South Brisbane
Belgium · 2 centers
- Universitair Ziekenhuis Gent — Ghent
- Universitair Ziekenhuis Leuven — Leuven
Italy · 2 centers
- Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico — Milan
- Fondazione Policlinico Universitario A Gemelli IRCCS — Roma
Brazil · 1 center
- State University of Campinas Joao Bennini — Campinas
Germany · 1 center
- Interdiszip Schwerpunkt fur Hamostaseologie — Giessen
Spain · 1 center
- Hosp Univ Vall D Hebron — Barcelona
United Kingdom · 1 center
- Birmingham Women's Hospital — Birmingham
Publications
- Tjoa ML, Orillion A, Mankoski R, Imran N, Mao C, Krumme A, Van Hoorde S, Linares-Rivas Rico B, Komatsu Y. Study Design of the Global Prospective Hemolytic Disease of the Fetus and Newborn Registry (GERANIUM). Am J Perinatol. 2026 Mar 20. doi: 10.1055/a-2816-3361. Online ahead of print. PMID 41862209
Identifiers
NCT: NCT07194070 · NOPRODEBF0001 · NOPRODEBF0001