GERANIUM
Research type
Research Study
Full title
Global Prospective Hemolytic Disease of the Fetus and Newborn Registry (GERANIUM)
IRAS ID
348223
Contact name
Katie Morris
Contact email
Sponsor organisation
Janssen -Cilag International NV.
Duration of Study in the UK
5 years, 10 months, 2 days
Research summary
1. Background and study aim:
Haemolytic disease of the newborn and foetus (HDFN) is a rare and potentially life-threatening blood disorder in babies (before and just after birth). HDFN occurs when the blood types of the pregnant individual and foetus/baby are incompatible, thus resulting in fast breakdown of red blood cells (RBCs) of the foetus/baby. This may lead to anaemia (low haemoglobin levels), jaundice* and other related problems.
*yellow discoloration of the skin because of the high levels of the chemical, bilirubin in blood.
Currently there is limited data on how well the current treatments work for pregnancies affected by HDFN.
In this study, researchers will look at the potential data from multiple centres and evaluate the risk of anaemia in babies (before and just after birth) of pregnant participants and how well treatment.2.Who can participate?
Pregnant participants aged 18 years or older who are at risk of HDFN in their current pregnancy.3.What does the study involve?
No treatment will be given as a part of this study and only data will be collected at medical centres that regularly test and treat pregnant participants with HDFN.
In this study data will be collected from participants for the duration of their pregnancy and for 2 years after delivery for parental participant and their neonate/infant/child.
Data collection process begins at enrolment and will be considered complete for eligible participants if all available data have been recorded in the electronic case report form (eCRF).
The study will end when we collect the last set of data from the final participant. The total duration of the study will be around 5 years. For participants who decide to withdraw, the reason for withdrawal will be recorded into the CRF and source document.4.What are the possible benefits and risks of participating?
Participants will not receive any benefit from taking part in this study, but the information that is learned from this study may help pregnant participants and their corresponding foetuses/neonates/infants/children at risk for HDFN for future treatment. There isn't much information available on how well the current treatments for HDFN work in the real-world settings.
There is no risk associated with the participants taking part in this study.
No investigational treatment will be provided as part of this study. Data will be collected from the time of enrolment which includes, how treatments are used, outcomes, and patterns for both pregnant participant and their babies if performed as part of SoC practice. Additionally, if participants agree, they will be asked to complete some health-related questionnaires and provide samples for testing at enrolment and at specific timepoints throughout follow-up. Parents or caregivers will also be asked to allow tests that check how their child’s brain is developing.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
25/EM/0142
Date of REC Opinion
12 Aug 2025
REC opinion
Further Information Favourable Opinion