Rheumatology
The MAMA Trial has been developed in response to a commissioned call from the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) and run by the National Perinatal Epidemiology Unit Clinical Trials Unit (NPEU CTU). The trial is designed to address the uncertainty and resulting variation in practice surrounding the effects of continuing or stopping biologics during pregnancy in women with inflammatory arthritis (RA, PsA, axSpa, and adult JIA).
It is a pragmatic randomised controlled trial which will evaluate arthritis disease activity, pregnancy and infant outcomes in women randomly allocated to continuing their biologic medication throughout pregnancy, or to stopping their biologic medication prior to 28 completed weeks' gestation and restarting no earlier than 2 weeks after the end of pregnancy. We will also be exploring the infant immunological response to these agents to add to the body of evidence regarding their safety and hope to provide valuable insights into the effect of in utero exposure to previously sparsely studied classes of biologics. An economic evaluation will also be conducted.
The overall results of this trial will provide valuable guidance for clinicians, patients, and policy makers.
Collaboration
We are currently seeking collaboration with rheumatologists to assist with the trial, by signposting MAMA Trial information to women with inflammatory arthritis being treated with biologics, who are pregnant or planning pregnancy.
Your expertise and involvement would be invaluable in ensuring the success of this study.
If you would like to know how your department might support the MAMA Trial, or if you would like help to build links with your local obstetric unit please email mama@npeu.ox.ac.uk.
You can read more about the MAMA Trial on the Information for Health Professionals page of this website and in the Information Leaflets and Resources section.
MAMA aims to recruit 328 women, over a 48-month period, predominantly across 35 Obstetric units. As each site opens to recruitment, the online MAMA Site Map will be updated, to help you find your local recruiter.
Thank you for your time and consideration, if you have any queries please contact us.
