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Keep this study
Lead
AstraZeneca
With
University of California, San Diego
Age
18–130
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Currently pregnant women diagnosed with asthma who contact the OTIS Research Center and who have been exposed to benralizumab for any number of days, at any dose, and at any time from 8 weeks before the first day of LMP up to and including the end of pregnancy.
Eligible participants will be currently pregnant women who agree to the conditions and requirements of the study including the interview schedule and release of medical records.
Currently pregnant women diagnosed with asthma and exposed to asthma medications for any number of days, at any dose, and at any time from LMP up to the date of enrollment, who contact the OTIS Research Center but who were not exposed to benralizumab during pregnancy or within 8 weeks prior to LMP.
Eligible participants will be currently pregnant women who agree to the conditions and requirements of the study including the interview schedule and release of medical records.
Currently pregnant women who contact the OTIS Research Center.
Eligible women may potentially have been exposed to non-teratogenic agents during this pregnancy.
Women who agree to the conditions and requirements of the study including the interview schedule and release of medical records.
You may not be if
Cohort 1: Benralizumab-Exposed
Women who have had exposure to another biologic, used for any indication, anytime during pregnancy or within 8 weeks of LMP.
Women will not be eligible for Cohort 1 if they first contact the OTIS Research Center after prenatal diagnosis of a major structural birth defect.
Restrospective cases (outcome of pregnancy known prior to enrollment).
Women who have enrolled in the current study with a previous pregnancy.
Cohort 2: Treated Diseased Comparison
Women with exposure to benralizumab any time during pregnancy or within 8 weeks prior to LMP.
Women will not be eligible for Cohort 2 if they first come in contact with the OTIS Research Center after prenatal diagnosis of a major structural birth defect.
Retrospective cases (outcome of pregnancy known prior to enrollment).
Women who have enrolled in the current study with a previous pregnancy.
Cohort 3: Non-Asthmatic Comparison
Women who have been exposed to any known teratogenic agents as determined by the OTIS Research Center (list in Annex 1) for any number of days, at any dose, from the first day of the last menstrual period up to and including the end of pregnancy.
Women with a self-reported diagnosis of asthma, current or previous.
Women will not be eligible for Cohort 3 if they come in contact with the OTIS Research Center after prenatal diagnosis of a major structural birth defect.
Retrospective cases (outcome of pregnancy known prior to enrollment).
Women who have enrolled in the current study with a previous pregnancy.
Clareo Health | Benralizumab Pregnancy Exposure Study
