Clinical Trials in Spain / NCT07194070
Recruiting
Observational
A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry
NCT07194070 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Hemolytic Disease of the Fetus and Newborn
Investigational drug(s) / intervention(s)
Standard of Care
Standard 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.
Study 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
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)
Primary outcome measure(s)
- Percentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death During the Neonatal Period — From conception through 4 weeks of age or 41 weeks PMA, whichever is later
Percentage of pregnancies that did not result in fetal loss (due to any reason), IUT, hydrops fetalis, or neonatal death (due to any reason) during the neonatal period will be reported. Hydrops fetalis is defined as the presence of greater than or equal to (\>=) 2 abnormal fluid collections in the fetus or neonate, such as ascites, pleural effusions, pericardial effusion, and generalized skin edema (skin thickness greater than \[\>\] 5 millimeter \[mm\]). Post-menstrual age (PMA) is the time elapsed between the first day of the last menstrual period and birth (gestational age) plus the time elapsed after birth (chronological age).
Trial sites (15)
| Facility | City | Region | Status |
|---|---|---|---|
| Riley Children s Hospital | Indianapolis | Indiana | Suspended |
| University of Rochester Medical Center | Rochester | New York | Recruiting |
| University of Cincinnati | Cincinnati | Ohio | Recruiting |
| Oregon Health And Science University | Portland | Oregon | Recruiting |
| Baylor College of Medicine | Houston | Texas | Recruiting |
| The Royal Women's Hospital | Parkville | Australia | Recruiting |
| Mater Misericordiae Ltd | South Brisbane | Australia | Recruiting |
| Universitair Ziekenhuis Gent | Ghent | Belgium | Recruiting |
| Universitair Ziekenhuis Leuven | Leuven | Belgium | Recruiting |
| State University of Campinas Joao Bennini | Campinas | Brazil | 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 |
More Janssen Research & Development, LLC trials in Spain
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07194070 on ClinicalTrials.gov ↗ ← All trials in Spain