OPTIMISE:MS – Pregnancy Registry
Research type
Research Study
Full title
The OPTIMISE:MS Pregnancy Registry – A Real World Pregnancy Pharmacovigilance Study
IRAS ID
279569
Contact name
Paul Matthews
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
6 years, 9 months, 5 days
Research summary
This is a pragmatic, a non-interventional, prospective observational cohort study planned to run for 6 years (Includes pregnancy and to the child’s 5th birthday). This study will build on the infrastructure formed as part of the main OPTIMISE:MS study, adding pregnancy-focused pharmacovigilance. Due to the need to contact healthcare providers for information over and above that recorded in the neurological records, this study needs additional approvals to the main study.
The pregnancy study will meet the needs of a significant subgroup of the MS community, alongside facilitating data gathering to inform scientists and clinicians of pregnancy outcomes in women with MS. It will enable systematic learning from prospectively acquired data around MS DMT exposure and pregnancy outcomes as well as follow up on the development of children for 5 years.
The study will recruit women with MS who are pregnant and currently taking part in the main OPTIMISE:MS study. This includes women with MS who are eligible for, and taking, disease modifying therapy (DMT) who are pregnant, and women with MS who are not receiving treatment and are pregnant. Women with MS who become pregnant who are not currently enrolled in the main study from participating centres across the country will also be eligible to take part in the study. This study will facilitate a way of exploring related questions regarding the relative benefits vs risks of treatment and the influence of prior treatments in women during pregnancy.
REC name
London - City & East Research Ethics Committee
REC reference
21/PR/0425
Date of REC Opinion
14 Jun 2021
REC opinion
Further Information Favourable Opinion