CompletedNot Applicable

A Study to Characterize the Clinical Course of Pregnant Women and Children at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn

United States17 participantsStarted 2019-01-16

Plain-language summary

The primary purpose of the study is to characterize the current standard of care, clinical course, and outcomes of pregnant women and their offspring at high risk for early onset severe hemolytic disease of the fetus and newborn (EOS-HDFN).

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Pregnant female participants must be ≥18 years of age with an estimated Gestational Age of ≥ 8 weeks; not currently pregnant with multiples (twins or more); and no other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate.

What they're measuring

Percentage of Participants With Live Birth at or After Gestational Age (GA) Week 32 Without Intrauterine Transfusion (IUT)

Timeframe: GA Week 32 through GA Week 37

Trial details

NCT IDNCT03755128

SponsorJanssen Research & Development, LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-09-22

View on ClinicalTrials.gov More Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN) trials