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

September 11, 2025 updated by: Janssen Research & Development, LLC

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Liverpool, Australia, 2170
        • Liverpool Hospital
      • Parkville, Australia, 3052
        • The Royal Women's Hospital
  • Belgium
      • Leuven, Belgium, 3000
        • Universitair Ziekenhuis Leuven
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • The University of British Columbia
    • Ontario
      • Toronto, Ontario, Canada, M5G1X5
        • Mount Sinai Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Centre Hospitalier Sainte Justine
  • Germany
      • Giessen, Germany, 35392
        • Justus-Liebig-Universität Gießen, Kinderherzzentrum
  • Netherlands
      • Leiden, Netherlands, 2333 ZA
        • Leiden University Medical Center
  • Spain
      • Barcelona, Spain, 08028
        • Hosp Clinic de Barcelona
      • Granada, Spain, 18016
        • Hosp. Univ. San Cecilio
  • Sweden
      • Stockholm, Sweden, SE-141 86
        • Karolinska Universitetssjukhuset Huddinge
  • United Kingdom
      • Edgbaston, United Kingdom, B15 2TG
        • Queen Elizabeth Hospital
      • London, United Kingdom, WC1E 6DB
        • University College London Hospitals NHSFT
  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants must have an obstetrical history of severe fetal anemia, hydrops, or stillbirth related to hemolytic disease of the fetus and newborn, have alloantibody titers for anti-D ≥32 or anti-Kell titers ≥4, and be currently pregnant with an antigen-positive fetus. Eligible women may enter the study at any time during the current pregnancy prior to delivery.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant women and their offspring from current pregnancy
Other: No intervention
No investigational drugs will be administered as part of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
GA Week 32 through GA Week 37

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2019

Primary Completion (Actual)

September 22, 2023

Study Completion (Actual)

September 22, 2023

Study Registration Dates

First Submitted

November 26, 2018

First Submitted That Met QC Criteria

November 26, 2018

First Posted (Actual)

November 27, 2018

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 11, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR109067
  • MOM-M281-103 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Erythroblastosis, Fetal

Clinical Trials on No intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe