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New study tracks High-Risk pregnancies to improve newborn health

NCT ID NCT03755128

Knowledge-focused Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study followed 17 pregnant women and their babies who were at high risk for early onset severe hemolytic disease of the fetus and newborn (EOS-HDFN). The goal was to see how the condition is currently managed and what outcomes occur. No new drugs were tested; instead, researchers observed standard care to gather real-world data.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors better understand how to manage high-risk pregnancies and improve outcomes for affected newborns.
What could go wrong
This is a small observational study with only 17 participants, so findings may not apply to everyone. It does not test any new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

17 people

The number who actually took part.

Started

Jan 2019

Finished

Sep 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

fetal erythroblastosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early onset severe hemolytic disease of the fetus and newborn (eos-HDFN) Erythroblastosis, fetal

Contacts and locations

Locations

  • Centre Hospitalier Sainte Justine

    Montreal, Quebec, H3T 1C5, Canada

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Hosp Clinic de Barcelona

    Barcelona, 08028, Spain

  • Hosp. Univ. San Cecilio

    Granada, 18016, Spain

  • Justus-Liebig-Universität Gießen, Kinderherzzentrum

    Giessen, 35392, Germany

  • Karolinska Universitetssjukhuset Huddinge

    Stockholm, SE-141 86, Sweden

  • Leiden University Medical Center

    Leiden, 2333 ZA, Netherlands

  • Liverpool Hospital

    Liverpool, 2170, Australia

  • Mount Sinai Hospital

    Toronto, Ontario, M5G1X5, Canada

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Queen Elizabeth Hospital

    Edgbaston, B15 2TG, United Kingdom

  • The Royal Women's Hospital

    Parkville, 3052, Australia

  • The University of British Columbia

    Vancouver, British Columbia, V6H 3N1, Canada

  • UPMC

    Pittsburgh, Pennsylvania, 15213, United States

  • Universitair Ziekenhuis Leuven

    Leuven, 3000, Belgium

  • University College London Hospitals NHSFT

    London, WC1E 6DB, United Kingdom

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States