Study Type of data Exposure measurement Outcome assessment Adjustment
Colvin, 2010 retrospective cohort (claims database) The national Pharmaceutical Benefits Scheme, with around 80% of prescriptions dispensed in Australia. Health administrative data from the WA Hospital Morbidity Data System, the Midwives’ Notification System, the WA Registry of Births and Deaths and the Birth Defect Registry of WA, enabling pregnancies and pregnancy outcomes to be ascertained. None
Fragoso a (control exposed to Glatiramer), 2013 retrospective cohort Data were obtained from the medical records of patients attending regular consultations with their neurologists. Data were obtained from the medical records of patients attending regular consultations with their neurologists. None
Fragoso a (control unexposed, sick), 2013 retrospective cohort Data were obtained from the medical records of patients attending regular consultations with their neurologists. Data were obtained from the medical records of patients attending regular consultations with their neurologists. None
Nguyen (control exposed to Glatiramer), 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
Weber-Schoendorfer (control exposed to Glatiramer), 2009 prospective cohort A structured questionnaire administered to physicians or mothers for details of drug exposure (timing in pregnancy, dose, and duration) at the first contact during (early) pregnancy, before the pregnancy outcome was known. Follow-up was conducted by a questionnaire mailed to the patient or her physician and/or the pediatrician. This questionnaire covered the results of the third pediatric check up at the age of 6 weeks. No adjustment for the outcomes of interest.
Weber-Schoendorfer (control unexposed, disease free), 2009 prospective cohort A structured questionnaire administered to physicians or mothers for details of drug exposure (timing in pregnancy, dose, and duration) at the first contact during (early) pregnancy, before the pregnancy outcome was known. Follow-up was conducted by a questionnaire mailed to the patient or her physician and/or the pediatrician. This questionnaire covered the results of the third pediatric check up at the age of 6 weeks. No adjustment for the outcomes of interest.
Weber-Schoendorfer (control unexposed, sick), 2009 prospective cohort A structured questionnaire administered to physicians or mothers for details of drug exposure (timing in pregnancy, dose, and duration) at the first contact during (early) pregnancy, before the pregnancy outcome was known. Follow-up was conducted by a questionnaire mailed to the patient or her physician and/or the pediatrician. This questionnaire covered the results of the third pediatric check up at the age of 6 weeks. No adjustment for the outcomes of interest.

master protocol