Global Prospective Hemolytic Disease of the Fetus and Newborn Registry
Study on Hemolytic Disease of the Fetus and Newborn
Hiba Mustafa, MD
Primary Investigator
Brief description of study
The purpose of the study is to prospectively evaluate treatment effectiveness and outcomes for alloimmunized pregnant participants and their corresponding fetuses, neonates, infants, and children at risk for HDFN in a real-world setting. This prospective registry enables the identification of risk factors, disease progression patterns, and treatment outcomes in ways that retrospective analyses or smaller-scale studies cannot achieve. This study aims to collect and analyze clinical data from pregnant individuals at risk for hemolytic disease of the fetus and newborn (HDFN). By tracking pregnancies and neonatal outcomes, the study seeks to improve understanding of disease progression and optimize patient care.
Detailed description of study
This is a prospective, longitudinal, global, non-interventional registry of pregnant participants, caregivers, and their corresponding fetuses, neonates, infants, and children at risk for HDFN in which physicians and patients will follow local clinical practice.
- Data at enrollment for the pregnant participant will be collected from the medical record or reported by the patient at the time of enrollment. Prospective data, including treatment utilization, outcomes, and patterns for both the pregnant participant and corresponding fetus/infant/neonate/child, will be collected from the time of enrollment within the registry if performed as part of SoC practice.
- The registry will collect data on pregnant participants and fetuses for the duration of the pregnancy and will collect data on maternal and neonate/infant/child participants for up to 2 years following birth.
- In the case of a multifetal pregnancy, data will be collected for each fetus/neonate/infant/child. For sequential pregnancies meeting study eligibility criteria, the pregnant participant would re-enroll and re-consent for data to be collected.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Pregnancy, Pregnant, Alloimmunized pregnancy, Hemolytic disease of the fetus and newborn, HDFN, Riley
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Age: 100 years or below
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Gender: All
Inclusion criteria
1. Aged 18 or older (or the legal age of consent in the jurisdiction in which the study is taking
place);
2. Pregnant with an estimated GA (based on ultrasound dating) up to week 24
3. History of at least one previous alloimmunized pregnancy that included at least one of the
following:
Fetal anemia diagnosed by MCA Doppler ultrasound
Received ≥1 IUT as a result of 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 DAT in neonate
4. Documented presence of maternal alloantibody based on local laboratory results during the
current pregnancy
5. Evidence of an antigen-positive fetus corresponding to the current maternal alloantibody:
Fetal antigen status confirmed by cffDNA OR
Fetal antigen status confirmed by amniocentesis OR
Paternal genotype confirmed
6. 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
7. Pregnant participant agrees to sign the Release of Medical Information Form, or equivalent
document, according to local regulations, by all persons who are required to give consent,
thereby permitting the participant’s HCP(s) and pediatric HCPs to be contacted for medical
information
Exclusion criteria
1. Participant actively participating in an interventional trial of an investigational agent
2. At risk for HDFN due to ABO being the sole alloimmunization antigen in the current pregnancy
(i.e., ABO plus another antigen is permissible)
This study investigates the condition known as Hemolytic Disease of the Fetus and Newborn (HDFN). HDFN occurs when a pregnant person's immune system attacks the red blood cells of their fetus, leading to anemia and other complications. This study is a global, prospective registry that collects data from pregnant individuals and their children to understand the disease better and identify effective treatments.
Participants will have data collected during routine clinical visits, including information from medical records and reports. This non-interventional study will track the health and treatment outcomes of both the pregnant individuals and their children over time, without altering their standard care.
- Who can participate: Pregnant individuals aged 18 or older, up to 24 weeks of gestation, with a history of alloimmunized pregnancy (when the immune system reacts to foreign antigens) and an antigen-positive fetus (a fetus with specific proteins that can trigger an immune response) are eligible. Participants must provide informed consent.
- Study details: Participants will have their medical data collected from routine clinical visits. The study will gather information on treatment and outcomes for both the pregnant participants and their children. This is a non-interventional study, meaning it does not change the participants' usual care.
- Study timelines: The study will last up to 2 years following birth.
