80202135EBF0001_Non Interventional Outcome of pregnancies with HDFN
Research type
Research Study
Full title
A Historical Cohort, Multicenter Study to Characterize the Management, Clinical Course, and Outcomes of Pregnancies in Women Who Have Experienced a Pregnancy With Early Onset Severe HDFN
IRAS ID
319489
Contact name
Rachel Morris
Contact email
Sponsor organisation
Janssen Research & Development, LLC
Clinicaltrials.gov Identifier
VV-CLIN-000430, 2.0, EDMS Number
Duration of Study in the UK
0 years, 4 months, 15 days
Research summary
This is a historical cohort, observational study designed to collect health information to gain further understanding on the management, clinical course, and risk of re-occurrence of severe haemolytic disease of the foetus and newborn (HDFN) in women who have had pregnancies with offspring affected by early onset severe (EOS)-HDFN.
Data will be used as an external control comparison to the data in the sponsor’s MOM-M281-003 study to evaluate nipocalimab when administered to pregnant women at high risk for EOS-HDFN.
HDN may develop when a mother and her unborn baby have different blood types. The types are based on small substances (antigens) on the surface of the blood cells.
Data will be collected from all eligible women from 2006 to 2019 who have had at least one pregnancy affected by EOS-HDFN and at least one subsequent antigen positive pregnancy.
The study consists of collecting health information already available in the participant’s medical records retrospectively. The study itself has no impact on their care. Participants will not be required to visit the study site. Maternal and foetal data will be obtained from the gestational period through birth. If available, neonatal data will be collected up to 12 weeks of age.
It is also aimed to collect information from women to understand pregnancy outcomes and explore how the disease has influenced their choices and decisions about pregnancy intention. This information will be collected via a telephone survey. The study is conducted over two phone calls. One to discuss the content of the participant information sheet and consent form and to allow the potential participant to ask questions and another, where the participant will be asked to answer the survey questions.
About 50 women will take part worldwide. An estimated 250 women will participate in the telephone survey worldwide.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
22/WM/0264
Date of REC Opinion
21 Nov 2022
REC opinion
Unfavourable Opinion