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 hospital
laboratories, through expert networks of infectious diseases specialists, obstetricians and
pediatricians in University hospitals from the Paris Area and suburbs that concentrate 50-55%
of malaria cases in France. They also collaborate with the National Research Center (NRC) for
malaria and will capture voluntary reports by clinicians and microbiologists in the NRC
network.
When contact is made to the call center, a trained staff member will acquaint the patient or
treating physician with the goals and procedures of the study. If the patient agrees to
participate in the study over the telephone, the patient's verbal consent will be documented,
and the patient will be sent the study Consent Form that includes the consent for the
patient's physician/obstetrician and the child's pediatrician to release medical information
via email. If a physician is contacting the Call Center, s/he may be provided with this form
to review, and the physician will be directed to ask the patient to telephone the Call Center
to provide consent. With the patient's consent, the patient's physician/obstetrician will be
contacted by a Call Center staff member and will be interviewed by a trained call center
healthcare professional/pharmacist for information about the patient including demographics,
malaria history, history of treatment, and initial pregnancy data. The Call Center will
contact the patient's physicians (including obstetrician and infant's pediatrician, as
appropriate) each trimester until delivery, and also at birth and 1 year after birth, to
collect data on maternal adverse events (AEs), pregnancy outcome, fetal outcome, and infant
outcome. Patients consented in France under the ARTEMUM study will undergo the consent
process by the treating Physician. Anonymized data will be prospectively collected by a
research technician under the supervision of a local manager in France.
Data collected by the call center will be sent to the Coordinating Center on a monthly basis
for review and tracking of participants, then annually for inclusion in the interim or final
report. Data collected as part of the ARTEMUM study will be provided in aggregate as summary
tables to be included in the annual report.