EOS - HDFN Natural History Study

• Research type

  Research Study

• Full 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

• IRAS ID

  251328

• Contact name

  Bryan York

• Contact email

  byork@momentapharma.com

• Sponsor organisation

  Momenta Pharmaceuticals, Inc.

• Clinicaltrials.gov Identifier

  NCT03755128

• Duration of Study in the UK

  4 years, 10 months, 31 days

• Research summary

  Summary of Research
  This is a natural history (prospective observational) protocol designed to collect health information to gain further understanding on the clinical course and management of pregnant women and their offspring at high risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN). No investigational drug will be administered as part of this study.\nApproximately 15 pregnant women and their offspring will participate in the study, which will be carried out at multiple study sites worldwide with expertise in maternal-fetal medicine and the treatment of the condition.\nEnrolled patients will undergo standard clinical assessments and receive standard of care treatment for EOS HDFN (ie, Intrauterine transfusions) as per local medical practice. Each physician is solely responsible for determining the appropriate clinical care for each patient. \nParticipating sites will record comprehensive medical history (incl previous pregnancies) for maternal patients at enrollment and any follow-up assessments through delivery up to and including the first visit after childbirth. Data on treatments administered as part of standard of care as well as data on other outcomes of interest and laboratory assessments related to the condition treatment will be collected. For the fetus and neonate/infant to age 3 months, medical and treatment data as well as outcomes of interest related to treatment for EOS HDFN will be collected. \nApproximately 15 eligible women and their offspring from the current pregnancy are planned to be enrolled. Patients who are pregnant to a gestational age (GA) of ≥8 weeks will be screened for inclusion during the current pregnancy, and may enroll in the study at any time during the current pregnancy prior to delivery. \nSummary statistics will be provided. Data collected in this study may be used in analysis of other HDFN studies.

  Summary of Results
  N/A

• REC name

  North of Scotland Research Ethics Committee 1

• REC reference

  18/NS/0105

• Date of REC Opinion

  7 Nov 2018

• REC opinion

  Further Information Favourable Opinion