The Mepolizumab Pregnancy Exposure Study The Mepolizumab Pregnancy Exposure Study is a prospective, observational, exposure cohort study of pregnancy outcomes in women exposed to mepolizumab during pregnancy compared to pregnancy outcomes in women who have not used mepolizumab during pregnancy but have used other anti-asthmatic medications (treated disease comparison group), and pregnancy outcomes in women exposed to other non-teratogenic agents (non-asthmatic comparison group). The purpose of the study is to monitor planned and unplanned pregnancies exposed to mepolizumab and to evaluate the effect of this medication relative to the primary pregnancy outcome of major birth defects and the secondary pregnancy outcomes of preterm delivery, small for gestational age infants and spontaneous abortion or stillbirth. PATIENT PARTICIPATION INVOLVES:
Eligibility Criteria: Three cohorts of pregnant women will be enrolled:
Enrolment should take place as early in the pregnancy as possible and prior to any knowledge of the pregnancy outcome. Healthcare providers and pregnant women are encouraged to notify GSK Safety Department of any pregnancies where exposure to mepolizumab has occurred and the pregnancy outcome is already known. An Eligible pregnant woman may self-enrol at any time during their pregnancy or, with their consent, their HCP may enrol them on their behalf. Contact Information: The study is conducted on behalf of GSK by: The Organization of Teratology Information Specialists (OTIS) Research Center University of California La Jolla San Diego California USA Telephone: 877.311.8972 Email: mothertobaby@ucsd.edu For more information, visit the MotherToBaby Website: http://www.mothertobaby.org/refer Enrolment Target Enrolment:
Study Start Date: November 2016 Estimated Completion Date: 2023 Additional Information:
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