Global registry for hemolytic disease of the fetus and newborn (HDFN)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.