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
- Conditions
- Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN)Erythroblastosis, Fetal
- Registration Number
- NCT03755128
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief 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).
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 17
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants With Live Birth at or After Gestational Age (GA) Week 32 Without Intrauterine Transfusion (IUT) GA Week 32 through GA Week 37
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Live Birth Up to approximately GA Week 37 Number of days of phototherapy required by neonate Post-Birth through Age 3 Months Number of Simple Transfusions Required by Neonate in the First 3 Months of Life Post-Birth through Age 3 Months Percentage of Participants at GA Week 24 Without an IUT Week 24 GA at First IUT Up to approximately GA Week 37 Percentage of Neonates Requiring Exchange Transfusions Post-Birth through Age 3 Months Number of IUTs Required Up to approximately GA Week 37 Percentage of Participants With Fetal Hydrops Post-Birth through Age 3 Months Percentage of Neonates Requiring Phototherapy Post-Birth through Age 3 Months Percentage of Neonates Requiring Simple Transfusions in the First 3 Months of Life Post-Birth through Age 3 Months
Trial Locations
- Locations (18)
Hosp Clinic de Barcelona
🇪🇸Barcelona, Spain
Karolinska Universitetssjukhuset Huddinge
🇸🇪Stockholm, Sweden
Columbia University Medical Center
🇺🇸New York, New York, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Liverpool Hospital
🇦🇺Liverpool, Australia
The Royal Women's Hospital
🇦🇺Parkville, Australia
Universitair Ziekenhuis Leuven
🇧🇪Leuven, Belgium
Scroll for more (8 remaining)Hosp Clinic de Barcelona🇪🇸Barcelona, Spain