Global registry for hemolytic disease of the fetus and newborn (HDFN)
Global Prospective Hemolytic Disease of the Fetus and Newborn Registry
This project will follow pregnant people at risk for HDFN to see how often their fetuses or newborns develop anemia while receiving standard care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 175 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Locations | 12 sites (Indianapolis, Indiana and 11 other locations) |
| Trial ID | NCT07194070 on ClinicalTrials.gov |
What this trial studies
This is a prospective, non-interventional registry enrolling pregnant participants up to 24 weeks' gestation who have a prior alloimmunized pregnancy, a documented maternal alloantibody in the current pregnancy, and evidence the fetus carries the corresponding antigen. Clinical data will be collected from routine care including middle cerebral artery Doppler results, any intrauterine transfusions, delivery findings, and neonatal outcomes such as direct antiglobulin test results, transfusions, and hyperbilirubinemia. Participating sites include Riley Children’s Hospital (Indianapolis), University of Cincinnati, and Oregon Health & Science University (Portland), with data captured according to local standard-of-care practices. The registry aims to characterize real-world risk and outcomes of fetal and neonatal anemia in pregnancies affected by HDFN to inform monitoring and management.
Who should consider this trial
Good fit: Ideal candidates are pregnant individuals up to 24 weeks' gestation with a history of an alloimmunized pregnancy, a documented maternal alloantibody in the current pregnancy, and confirmed fetal antigen positivity.
Not a fit: People without a documented maternal alloantibody, without prior alloimmunized pregnancy, with an antigen-negative fetus, or who cannot attend participating sites are unlikely to receive direct benefit from participation.
Why it matters
Potential benefit: If successful, the registry could help doctors better predict which pregnancies are most likely to develop fetal or neonatal anemia and guide monitoring and treatment decisions.
How similar studies have performed: Monitoring methods like MCA Doppler and targeted registries for alloimmunized pregnancies have improved detection and treatment of fetal anemia, though large-scale global registries focused specifically on HDFN remain limited.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Indianapolis, Indiana and 11 other locations
- Riley Children s Hospital — Indianapolis, Indiana, 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 Leuven — Leuven, Belgium (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)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.