Study Design of the Global Prospective Hemolytic Disease of the Fetus and Newborn Registry (GERANIUM).
May Lee Tjoa, Ashley Orillion, Raymond Mankoski...
https://pubmed.ncbi.nlm.nih.gov/41862209Actively Recruiting
Age: 18Years +
FEMALE
ID07194070
Global Prospective Hemolytic Disease of the Fetus and Newborn Registry
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
175
Participants Needed
13
Research Sites
18 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the risk of anemia in babies before and just after birth whose mothers are at risk for hemolytic disease of the fetus and newborn (HDFN). HDFN happens when the blood types of the pregnant participant and baby do not match, causing the baby's red blood cells to break down quickly. This non-interventional study aims to better understand this risk by following pregnant participants with HDFN risk and their babies over time. Pregnant participants who are at risk for HDFN during their current pregnancy will be enrolled and receive standard medical care according to their local practice. The study does not provide any treatment but collects data throughout pregnancy and for two years after birth from medical records and participant-reported outcomes. Data collection will occur at medical centers experienced in diagnosing and treating HDFN. Participants will provide medical information during pregnancy and after birth, including clinical outcomes and questionnaires about health status. Researchers will measure the percentage of pregnancies without fetal loss, intrauterine transfusions, hydrops fetalis, or neonatal death up to four weeks after birth. They will also track the severity of HDFN, timing of complications, and transfusions received. The study follows participants from conception through two years after delivery to gather long-term data.
CONDITIONS
Brief Title
A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Pregnant with an estimated gestational age up to 24 weeks based on ultrasound
- History of a previous alloimmunized pregnancy with fetal anemia, intrauterine transfusion(s), hydrops fetalis, stillbirth or fetal demise due to HDFN, neonatal exchange or simple transfusion due to HDFN, neonatal hyperbilirubinemia due to HDFN, or positive direct antiglobulin test in neonate
- Documented presence of maternal alloantibody during current pregnancy
- Evidence of an antigen-positive fetus confirmed by cell-free fetal DNA, amniocentesis, or paternal genotype
- Pregnant participant or legally acceptable representative has provided informed consent for collection and use of medical data
You will not qualify if you...
- Actively participating in an interventional trial of an investigational agent
- At risk for HDFN due to ABO being the sole alloimmunization antigen in current pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - From enrollment through 2 years post-birth
Participants who undergo routine care for Hemolytic Disease of the Fetus and Newborn (HDFN) are observed. Data and clinical outcome assessments are collected throughout pregnancy and up to 2 years after birth for the child.
Visits as per routine clinical care and scheduled assessments during pregnancy and follow-up
Trial Site Locations
Total: 13 locations
1
Riley Children s Hospital
Indianapolis, Indiana, United States, 46202-5225
Actively Recruiting
2
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
3
Oregon Health And Science University
Portland, Oregon, United States, 97239
Actively Recruiting
4
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
5
The Royal Women's Hospital
Parkville, Australia, 3052
Actively Recruiting
6
Mater Misericordiae Ltd
South Brisbane, Australia, 4101
Actively Recruiting
7
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
8
Universitair Ziekenhuis Leuven
Leuven, Belgium, 3000
Actively Recruiting
9
Interdiszip Schwerpunkt fur Hamostaseologie
Giessen, Germany, 35392
Actively Recruiting
10
Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
11
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, Italy, 00137
Actively Recruiting
12
Hosp Univ Vall D Hebron
Barcelona, Spain, 8035
Actively Recruiting
13
Birmingham Women's Hospital
Birmingham, United Kingdom, B15 2TG
Actively Recruiting
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Research Team
S
Study Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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