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 (J&J Innovative Medicine)

Status: Completed

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

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT03755128

CR109067

MOM-M281-103

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 17 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

17 participants in 1 patient group

Pregnant women and their offspring from current pregnancy

Treatment:

Other: No intervention