A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry
Recruiting
Observational Study
Hemolytic Disease of the Fetus and Newborn
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Observational
- Participants needed
- 175 (estimated)
- Sponsor
- Janssen Research & Development, LLC · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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 t…
Contacts