The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes, fetal and infant outcomes after exposure. Early and later term pregnancy outcomes will be solicited at selected gestational time points. Structural and functional birth defects identified in the perinatal period through one year of life will be collected and classified. This is a non-proprietary registry and is a component of a comprehensive pregnancy Risk Evaluation and Mitigation Strategy (REMS) plan required by the FDA for all mycophenolate-formulations, including CellCept, Myfortic and any generic formulations.
Study Type
OBSERVATIONAL
Enrollment
500
Quintiles Outcome
Cambridge, Massachusetts, United States
Maternal Outcomes: Incidence of Pregnancy Complications
Time frame: Approximately 13 years
Fetal Outcomes: Incidence of Congenital Disorders
Time frame: Approximately 13 years
Time/Duration of Mycophenolate Exposure
Time frame: Approximately 13 years
Mycophenolate Dose/Regimen
Time frame: Approximately 13 years
Indications for Mycophenolate use
Time frame: Approximately 13 years
Maternal Medical/Demographic Characteristics
Time frame: Approximately 13 years
Occurrence of Educational Counseling on the Increased Risks of Birth Defects With Mycophenolate Therapy
Time frame: Approximately 13 years
Reference Study ID Number: ML22679 https://forpatients.roche.com/
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