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

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

Sponsors

Lead Sponsor: Momenta Pharmaceuticals, Inc.

Source Momenta Pharmaceuticals, Inc.
Brief 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).

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.

Overall Status Recruiting
Start Date August 12, 2019
Completion Date January 2021
Primary Completion Date January 2021
Study Type Observational
Primary Outcome
Measure 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
Measure 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
Enrollment 15
Condition
Intervention

Intervention Type: Other

Intervention Name: No intervention

Description: No investigational drugs will be administered as part of the study

Arm Group Label: Pregnant women and their offspring from current pregnancy

Eligibility

Sampling Method: Probability Sample

Criteria:

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.

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Momenta General Queries Study Director Momenta Pharmaceuticals, Inc.
Overall Contact

Last Name: Momenta General Queries

Phone: +1 617-715-5094

Email: [email protected]

Location
Facility: Status:
Momenta Investigational Site | New York, New York, 10032, United States Recruiting
Momenta Investigational Site | Cincinnati, Ohio, 45267, United States Recruiting
Momenta Investigational Site | Pittsburgh, Pennsylvania, 15232, United States Recruiting
Momenta Investigational Site | Houston, Texas, 77030, United States Withdrawn
Momenta Investigational Site | Salt Lake City, Utah, 84132, United States Recruiting
Momenta Investigational Site | Sydney, New South Wales, 2170, Australia Recruiting
Momenta Investigational Site | Parkville, Victoria, 3052, Australia Recruiting
Momenta Investigational Site | Leuven, Flemish Brabant, 3000, Belgium Recruiting
Momenta Investigational Site | Vancouver, British Columbia, V6H 3N1, Canada Suspended
Momenta Investigational Site | Giessen, Hessen, 35392, Germany Recruiting
Momenta Investigational Site | Leiden, Zuid-Holland, 2333 ZA, Netherlands Recruiting
Momenta Investigational Site | Barcelona, 8028, Spain Recruiting
Momenta Investigational Site | Granada, 18012, Spain Recruiting
Momenta Investigational Site | Stockholm, 17176, Sweden Recruiting
Momenta Investigational Site | Birmingham, England, B15 2TG, United Kingdom Recruiting
Momenta Investigational Site | London, England, NW1 2BU, United Kingdom Recruiting
Location Countries

Australia

Belgium

Canada

Germany

Netherlands

Spain

Sweden

United Kingdom

United States

Verification Date

August 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Pregnant women and their offspring from current pregnancy

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov