Natalizumab

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Ebrahimi (control unexposed, disease free), 2015	prospective cohort	Pregnant women registered to this database are followed prospectively either through telephone interviews every three months, or by visits to the university-based outpatient clinic. All self-reported data are collected through standardized questionnaires.	Pregnant women registered to this database are followed prospectively either through telephone interviews every three months, or by visits to the university-based outpatient clinic. Details of neonatal health and birth defects were confirmed with the child’s physician by letter communication.	None
Ebrahimi (control unexposed, sick), 2015	prospective cohort	Pregnant women registered to this database are followed prospectively either through telephone interviews every three months, or by visits to the university-based outpatient clinic. All self-reported data are collected through standardized questionnaires.	Pregnant women registered to this database are followed prospectively either through telephone interviews every three months, or by visits to the university-based outpatient clinic. Details of neonatal health and birth defects were confirmed with the child’s physician by letter communication.	None
Nguyen (control exposed to IFN), 2019	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.	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 pregnancy outcomes.	None
Nguyen (control unexposed, sick), 2019	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.	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 pregnancy outcomes.	None
Portaccio (control exposed to IFN), 2018	prospective cohort	All the patients were regularly followed up every 6 months and in the case of relapse.	Data were collected by the neurologist within 6 months after the delivery using a standardized information form dealing with pregnancy outcomes. In case of problems, the baby’s clinical charts were reviewed.	None
Portaccio (control unexposed, sick), 2018	prospective cohort	All the patients were regularly followed up every 6 months and in the case of relapse.	Data were collected by the neurologist within 6 months after the delivery using a standardized information form dealing with pregnancy outcomes. In case of problems, the baby’s clinical charts were reviewed.	Stepwise multivariable logistic and linear models were used. Possible confounders the main demographic and clinical variables and other variables with (p < 0.20) in univariate analysis, among educational level, previous pregnancies and abortions, smoking, alcohol and substance exposure during pregnancy, gestational age, and sex.

master protocol