A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry

Conditions

• Hemolytic Disease of the Fetus and Newborn

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Standard of Care — OTHER
  No study treatment will be administered as part of this study. Participants will receive standard of care therapy as per local clinical practice.

Study Details

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.

Key Dates

Start date

Dec 17, 2025

Status verified

Jun 2026

Primary completion

May 26, 2030

Completion

Sep 30, 2030

Study Design

Enrollment

175 participants (estimated)

Arms

• Arm: Pregnant Participants at Risk for Hemolytic Disease of the Fetus and Newborn (HDFN)
  Pregnant participants with a risk for HDFN in their current pregnancy will be enrolled. No treatment will be provided by the sponsor as a part of this study. Only data will be collected for participants for the duration of their pregnancy and for 2 years following birth for their corresponding neonate/infant/child. Data will be collected from eligible participants at medical centers that routinely diagnose and treat pregnant participants with HDFN. Additionally, participants will be asked to complete versions of clinical outcome assessments (Patient-reported outcomes \[PROs\]/Observer-reported outcomes \[ObsROs\]) at specific times throughout follow-up. Data collection will be considered complete for eligible participants if all available data have been recorded in the electronic case report form (eCRF).

Primary Outcome Measure

Percentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death During the Neonatal Period [ Time Frame: From conception through 4 weeks of age or 41 weeks PMA, whichever is later ]

Central Contacts

• Study Contact
  844-434-4210
  [email protected]

Locations (4)

Find similar trials in Indianapolis, IN

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