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

Janssen Research & Development, LLC17 enrolled

Overview

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).

The outcomes of interest will be assessed from the information collected on the standard of care treatment for EOS-HDFN in pregnant women and their offspring from current pregnancy.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN)Erythroblastosis, Fetal

Interventions

No interventionOTHER

No investigational drugs will be administered as part of the study

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (18)

Columbia University Medical Center

New York, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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

Time frame: GA Week 32 through GA Week 37

Secondary Outcomes

Percentage of Participants With Live Birth

Time frame: Up to approximately GA Week 37

Percentage of Participants at GA Week 24 Without an IUT

Time frame: Week 24

GA at First IUT

Time frame: Up to approximately GA Week 37

Number of IUTs Required

Time frame: Up to approximately GA Week 37

Percentage of Participants With Fetal Hydrops