Observational Study of the Safety of Intravenous Artesunate Treatment of Pregnant Women and Their Infants
Amivas Inc.
Summary
This study is a prospective observational study in which a female patient who received IV Artesunate while pregnant can volunteer to provide information about her pregnancy and the outcome of her pregnancy. Information will be collected from patient's provider, the patient's obstetrician, the child's pediatrician, or other relevant healthcare provider.
Description
Pregnant women or physicians treating pregnant women with severe malaria with IV Artesunate will become aware of the Pregnancy Registry via the product label, the Amivas Inc. website, or her physician. By calling 1-855-526-4827 (1-855-5AMIVAS) or contacting www.amivas.com/our-products, the patient or physician will be connected to the Pregnancy Registry Call Center. In France, the Collaborating-Investigators conducting the ARTEMUM observatory study have a wide information campaign among obstetrical wards, neonatal wards, Infectious Diseases wards, intensive care units (ICU), and parasitology h…
Eligibility
- Age range
- 15–100 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Patient received IV Artesunate * Patient was pregnant while receiving IV Artesunate * Patient was at least 15 years of age * Patient or legal guardian/representative gave consent for the study and to collect data from her physicians Exclusion Criteria • None
Location
- 4C Pharma SolutionsPiscataway, New Jersey