Clinical changes of Inflammatory Rheumatic Disease in Pregnancy study
Research type
Research Study
Full title
Understanding the Clinical and Immunological Changes of Inflammatory Rheumatic Disease in Pregnancy Study
IRAS ID
220035
Contact name
Hanh Nguyen
Contact email
Sponsor organisation
University of Bath
Clinicaltrials.gov Identifier
17/CBS/6827, CBS cooking reference number
Duration of Study in the UK
3 years, 11 months, 30 days
Research summary
Inflammatory Rheumatic Diseases (IRD) such as Systemic Lupus Erythematosus (SLE) and Rheumatoid Arthritis (RA) commonly occur in women of reproductive age. These IRDs occur due to the hyperactivity of the immune system, which arises due to a combination of genetic and environmental factors. IRD occurs in approximately one million of the UK population. Women with an IRD have a higher risk of experiencing a complications in pregnancy that can potentially cause harm to a mothers and/or babies health. There is an increased risk of adverse pregnancy outcomes associated with active, poorly controlled rheumatic disease in patients with IRD.
The management of IRD during pregnancy is complicated by a complex relationship with disease activity and often multiple medications that may be incompatible with pregnancy. We are unable to predict which patients are most likely to improve or get worse in pregnancy, and we are not sure if anti-rheumatic medications are safe/compatible in pregnancy. The effect of pregnancy itself upon disease activity and the long term outcomes for babies exposed to anti-rheumatic drugs in utero and/or at breastfeeding remain unclear.
This study will be of a prospective and observational nature and it will involve the recruitment of pregnant and non-pregnant patients with/without an IRD from the outpatient services at University College London Hospital.
The aims/purpose of this study will be to:
(i) Investigate whether alterations in disease activity occurs in pregnancy
(ii) Understand if pregnancy is associated with the relapse of IRD flares
(iii) Assess whether medication influences mother and baby pregnancy outcomesAn increased understanding of the relationship between IRD activity and pregnancy outcomes and identification of predictors of disease remission/relapse will improve management of these patients in pregnancy.
Summary of study results:
This first prospective case-controlled study of rheumatoid arthritis, Juvenile Idiopathic Arthritis, Systemic Lupus Erythematosus and healthy pregnancies has identified favourable and comparable pregnancy outcomes between inflammatory rheumatic disease pregnancies with good disease control. This study highlights the importance and need for pregnant women to undergo pre-pregnancy counselling and maintenance of disease control using compatible drugs during pregnancy to enhance the chances of successful pregnancy outcomes.
REC name
East of England - Essex Research Ethics Committee
REC reference
17/EE/0506
Date of REC Opinion
17 Jan 2018
REC opinion
Further Information Favourable Opinion