Global Prospective Hemolytic Disease of the Fetus and Newborn Registry
Janssen Research & Development, LLC
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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;…
Interventions
- OtherStandard 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.
Locations (12)
- Riley Children s HospitalIndianapolis, Indiana
- University of CincinnatiCincinnati, Ohio
- Oregon Health And Science UniversityPortland, Oregon
- Baylor College of MedicineHouston, Texas
- The Royal Women's HospitalParkville
- Mater Misericordiae LtdSouth Brisbane