Study | Country Study period |
Population source | Exposure definition | Non-exposure definition | Sample size | Rmk |
---|---|---|---|---|---|---|
Gold, 2015 |
Worldwilde Until June 2014 |
Pregnancies that occurred during the dimethyl fumarate (DMF) clinical development program (including healthy controls and patients with MS, with exposure to placebo, DMF, or glatiramer acetate (GA)). | Pregnancies exposed to dimethyl fumarate (DMF). |
unexposed, sick
Pregnancies exposed to placebo. |
42 / 13 | Only data related to clinical trials was used in this meta-analysis, in order to have a control group. |
Nguyen (control exposed to IFN), 2019 |
International 2005 - 2016 |
Women of child-bearing age (15–45 years inclusive), prospectively enrolled in MSBase with a diagnosis of relapsing-remitting MS (RRMS). | Pregnancies occurring during dimethyl fumarate therapy. (This is a subgroup of exposure among the exposed group considered in the study). |
exposed to other treatment, sick
Pregnancies occurring during Interferon beta (all) therapy. (This is a subgroup of exposure among the exposed group considered in the study). |
17 / 350 | |
Nguyen (control unexposed, sick), 2019 |
International 2005 - 2016 |
Women of child-bearing age (15–45 years inclusive), prospectively enrolled in MSBase with a diagnosis of relapsing-remitting MS (RRMS). | Pregnancies occurring during dimethyl fumarate therapy. (This is a subgroup of exposure among the exposed group considered in the study). |
unexposed, sick
Pregnancies not exposed to disease-modifying therapies (DMTs) (pregnancy occurring within a year of DMT discontinuation or without DMT exposure in the prior year). |
17 / 886 |
Study | Country Study period |
Case | Control | Sample size | Rmk |
---|
1 study, not fulfilled eligibility criteria, were excluded. See excluded tab for the list of these studies and reason of exclusion.