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NCT Number: NCT03755128

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

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).

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Key information

Conditions

Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Erythroblastosis, Fetal Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Infant, Newborn, Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Liverpool Hospital, Liverpool, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No investigational drugs will be administered as part of the study

Primary outcomes

  1. 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

  1. Percentage of Participants With Live Birth

    Time frame: Up to approximately GA Week 37

  2. Percentage of Participants at GA Week 24 Without an IUT

    Time frame: Week 24

  3. GA at First IUT

    Time frame: Up to approximately GA Week 37

  4. Number of IUTs Required

    Time frame: Up to approximately GA Week 37

  5. Percentage of Participants With Fetal Hydrops

    Time frame: Post-Birth through Age 3 Months

  6. Percentage of Neonates Requiring Phototherapy

    Time frame: Post-Birth through Age 3 Months

  7. Percentage of Neonates Requiring Exchange Transfusions

    Time frame: Post-Birth through Age 3 Months

  8. Number of days of phototherapy required by neonate

    Time frame: Post-Birth through Age 3 Months

  9. Percentage of Neonates Requiring Simple Transfusions in the First 3 Months of Life

    Time frame: Post-Birth through Age 3 Months

  10. Number of Simple Transfusions Required by Neonate in the First 3 Months of Life

    Time frame: Post-Birth through Age 3 Months

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 27, 2018
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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