Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

272MS402

The primary objective of the study is to estimate the prevalence of major congenital malformations (MCMs) and compare the prevalence between the diroximel fumarate (DRF) and comparator groups. The secondary objectives of the study are to estimate the incidence of spontaneous abortion (SA) and compare the incidence between the DRF and comparator groups; to estimate the incidence of preterm birth and compare the incidence between the DRF and comparator groups; to estimate the incidence of stillbirth and compare the incidence between the DRF and comparator groups and to estimate the prevalence of small for gestational age (SGA) and compare the prevalence between the DRF and comparator groups.

2021-09-24

2031-01-17

2031-01-17

Recruiting

1178

Key Inclusion Criteria: * Last menstrual period (LMP) between 29 October 2019 and 31 July 2030. * Continuous medical and pharmacy coverage for a minimum of 6 months prior to and including the estimated LMP. * Presence of MS. Key Exclusion Criteria: - Pregnancies will be excluded from this study if they are exposed to any known teratogens from the beginning of baseline through the end of the relevant exposure window. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '1 Year', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1178, 'type': 'ESTIMATED'}}

2023-10-13