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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicenter, Prospective Observational 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
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Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN), Erythroblastosis, Fetal

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women and their offspring from current pregnancy<br> | Other: No intervention<br>* No investigational drugs will be administered as part of the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Live Birth |  | Up to approximately GA Week 37 | 
| Percentage of Participants at GA Week 24 Without an IUT |  | Week 24 | 
| GA at First IUT |  | Up to approximately GA Week 37 | 
| 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 Exchange Transfusions |  | Post-Birth through Age 3 Months | 
| Number of days of phototherapy required by neonate |  | 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 | 
| Number of Simple Transfusions Required by Neonate in the First 3 Months of Life |  | Post-Birth through Age 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemolytic disease of the fetus and newborn (HDFN), Erythroblastosis, Fetal, Early onset severe hemolytic disease of the fetus and newborn (EOS-HDFN), M281, Pregnant Women