Dimethyl fumarate - Medication and Pregnancy KB

Dimethyl fumarate

Exposed non-exposed, cohort studies

Study	Country Study period Study design	Data source	Exposure definition	Non-exposure definition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias
Gold 2015	Worldwilde Until June 2014 retrospective cohort	Clinical development program of dimethyl fumarate (DMF).	Pregnancies exposed to dimethyl fumarate (DMF).	unexposed, sick Pregnancies exposed to placebo.	during pregnancy (anytime or not specified)	42 / 13	Only data related to clinical trials was used in this meta-analysis, in order to have a control group.
Gold 2015	Worldwilde Until June 2014 retrospective cohort	Clinical development program of dimethyl fumarate (DMF).	Clinical studies with administration of DMF. The study treatment was discontinued immediately in the event of pregnancy.		during pregnancy (anytime or not specified)	42 / 13
Nguyen (control exposed to IFN) 2019	International 2005 - 2016 prospective cohort	The Multiple Sclerosis (MS) Base Registry is a large, international observational cohort study, with long-term prospectively collected data.	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).	during pregnancy (anytime or not specified)	17 / 350
Nguyen (control exposed to IFN) 2019	International 2005 - 2016 prospective cohort		Data in the MSBase registry, including prospective pregnancy data, is entered in real time or near real time, as part of routine clinical visits. Information collected included: disease-modifying therapies exposure before and during pregnancy.		during pregnancy (anytime or not specified)	17 / 350
Nguyen (control unexposed, sick) 2019	International 2005 - 2016 prospective cohort	The Multiple Sclerosis (MS) Base Registry is a large, international observational cohort study, with long-term prospectively collected data.	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).	during pregnancy (anytime or not specified)	17 / 886
Nguyen (control unexposed, sick) 2019	International 2005 - 2016 prospective cohort		Data in the MSBase registry, including prospective pregnancy data, is entered in real time or near real time, as part of routine clinical visits. Information collected included: disease-modifying therapies exposure before and during pregnancy.		during pregnancy (anytime or not specified)	17 / 886

Case-control studies

Study	Country Study period Study design	Data source	Case	Control	Exposition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias

Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;

Empty. There are no case-control studies available for this drug.

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