Pregnancy in Rheumatic disease Investigation NeTwork (PRINT)
Research type
Research Study
Full title
Pregnancy in Rheumatic disease Investigation NeTwork (PRINT)\n
IRAS ID
211098
Contact name
Ian Giles
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
N/A, n/A
Duration of Study in the UK
10 years, 9 months, 30 days
Research summary
Inflammatory rheumatic diseases (IRD) - such as systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) – affect around 1 million people in the UK and are more common in women than men. Women with these diseases have an over-activation of their immune system and increased risk of complications in pregnancy that may cause significant health problems for mother and child beyond pregnancy. Our ability to treat these diseases in pregnancy however, is limited in several ways. First, we do not fully understand the relationship between immune system activation, active inflammatory rheumatic disease and pregnancy complications. Second, we are unable to predict which patients are most likely to improve or get worse in pregnancy. Third, we are uncertain whether certain anti-rheumatic drugs are truly safe in pregnancy. \n\nThe purpose of this study is to try and identify inflammatory factors that increase disease activity and adverse pregnancy outcomes in pregnancy to allow us to develop new predictive tests and to study safety of anti-rheumatic drugs in pregnancy and breastfeeding. We will study these factors through collection of your clinical information and samples of your blood, placenta, cord-blood and/or breastmilk. We can collect your blood by taking an extra amount from samples that you will have as part of your routine care. It is easy and harmless to you and your baby for us to collect a sample from your placenta and blood from the umbilical cord once it has been cut after birth. We can then measure various different inflammatory factors in your blood and placenta and correlate them with disease activity and pregnancy outcomes. In addition, we will measure the amount of any rheumatic drug that is transferred to your baby by comparing levels of the drug in your blood with that of the cord blood at birth. We will also measure the amount of any anti-rheumatic drug that is transferred into your breast milk.\n
REC name
North of Scotland Research Ethics Committee 1
REC reference
18/NS/0077
Date of REC Opinion
18 Jul 2018
REC opinion
Further Information Favourable Opinion