Observational Study of the Safety of Intravenous Artesunate Treatment of Pregnant Women and Their Infants

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age15-100
SponsorAmivas Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Pregnant women worldwide who were or are being treated with IV Artesunate who can be properly consented to provide personal health information on her pregnancy and agree to provide health information on her fetus, neonate, and infant child will be included in the study. Although IV Artesunate is indicated for the treatment of severe malaria, women who were treated off label for another indication who received IV Artesunate while pregnant will be included in the study as well.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Number of pregnant females with high blood pressure

Number of pregnant females with high blood pressure reported in medical record

Time frame
Through study completion, an average of 40 weeks
2

Number of pregnant females with severe nausea

Number of pregnant females with severe nausea reported in medical record

Time frame
Through study completion, an average of 40 weeks
3

Number of pregnant females with vomiting

Number of pregnant females with vomiting reported in medical record

Time frame
Through study completion, an average of 40 weeks
4

Number of pregnant females with dehydration

Number of pregnant females with dehydration reported in medical record

Time frame
Through study completion, an average of 40 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.