Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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).

Official 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

Details

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.

Keywords

Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN) Erythroblastosis, Fetal Hemolytic disease of the fetus and newborn (HDFN) M281 Pregnant Women Hemolysis No intervention Pregnant women and their offspring from current pregnancy

Eligibility

For females ages 18 years and up

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.

Locations

  • University of California San Francisco not yet accepting patients
    San Francisco California 94143 United States
  • University of Utah accepting new patients
    Salt Lake City Utah 84132 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Momenta Pharmaceuticals, Inc.
Links
To learn how to participate in this trial please click here.
ID
NCT03755128
Study Type
Observational
Last Updated