Observational Study of Intravenous Artesunate for Pregnant Women with Malaria
This study is looking at the safety of intravenous (IV) Artesunate, a medicine used to treat malaria, when given to pregnant women. It's an observational study, meaning researchers will collect information from women who have already received IV Artesunate during their pregnancy. They want to understand how the treatment affects the pregnancy and the baby. Researchers will gather details about your pregnancy, including if you experienced high blood pressure, severe nausea, or vomiting, up until about 40 weeks of pregnancy. You can join if you are at least 15 years old, were pregnant when you received IV Artesunate, and agree to share your information. The study aims to enroll 25 participants, but its current status is unclear.
- Study design
- This is an observational study, meaning researchers will collect information without giving any new treatments. It plans to include 25 participants.
- What's involved
- You would provide information about your pregnancy and its outcome, which will be collected from your healthcare providers.
- Compensation
- Not stated in the trial record.
- Follow-up
- Information will be collected through study completion, an average of 40 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Observational Study of the Safety of Intravenous Artesunate Treatment of Pregnant Women and Their Infants
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Bryan Smith, MD · PRINCIPAL_INVESTIGATOR · Amivas Inc.
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
What this trial measures
- Number of pregnant females with high blood pressureThrough study completion, an average of 40 weeks
Number of pregnant females with high blood pressure reported in medical record
- Number of pregnant females with severe nauseaThrough study completion, an average of 40 weeks
Number of pregnant females with severe nausea reported in medical record
- Number of pregnant females with vomitingThrough study completion, an average of 40 weeks
Number of pregnant females with vomiting reported in medical record
- Number of pregnant females with dehydrationThrough study completion, an average of 40 weeks
Number of pregnant females with dehydration reported in medical record
- Number of pregnant females with diabetes (newly occurring)Through study completion, an average of 40 weeks
Number of pregnant females with diabetes (newly occurring) reported in medical record
- Number of pregnant females with obesity/marked weight gainThrough study completion, an average of 40 weeks
Number of pregnant females with obesity/marked weight gain reported in medical record
- Number of pregnant females with anemia (newly occurring)Through study completion, an average of 40 weeks
Number of pregnant females with anemia (newly occurring) reported in medical record
- Number of pregnant females with kidney or bladder infectionsThrough study completion, an average of 40 weeks
Number of pregnant females with kidney or bladder infections reported in medical record
- Number of pregnant females with vaginal bleedingThrough study completion, an average of 40 weeks
Number of pregnant females with vaginal bleeding reported in medical record
- Number of pregnant females with abruptio placentaThrough study completion, an average of 40 weeks
Number of pregnant females with abruptio placenta reported in medical record
- Number of pregnant females with placenta previaThrough study completion, an average of 40 weeks
Number of pregnant females with placenta previa reported in medical record
- Number of pregnant females with premature rupture of membranesThrough study completion, an average of 40 weeks
Number of pregnant females with premature rupture of membranes reported in medical record
- Number of pregnant females with preterm laborThrough study completion, an average of 40 weeks
Number of pregnant females with preterm labor reported in medical record
- Number of pregnant females with ectopic pregnancyThrough study completion, an average of 40 weeks
Number of pregnant females with ectopic pregnancy reported in medical record
- Number of pregnant females with molar pregnancyThrough study completion, an average of 40 weeks
Number of pregnant females with molar pregnancy reported in medical record
- Number of pregnant females who diedThrough study completion, an average of 40 weeks
Number of pregnant females who died reported in medical record
- Number of pregnant females with spontaneous abortions/miscarriageUp to 20 weeks
Number of pregnant females with spontaneous abortions/miscarriage reported in medical record
- Number of pregnant females with elective terminationsThrough study completion, an average of 40 weeks
Number of pregnant females with elective terminations reported in medical record
- Number of fetal deaths/stillbirthsFrom 20 weeks to study completion
Number of fetal deaths/stillbirths reported in medical record
- Number of premature live births (<37 weeks)Up to 37 weeks
Number of premature live births (\<37 weeks) reported in medical record
- Number pregnant females with with live term birthsThrough study completion, an average of 40 weeks
Number pregnant females with with live term births reported in medical record
- Number of pregnant females with normal vaginal delivery or C-sectionThrough study completion, an average of 40 weeks
Number of pregnant females with normal vaginal delivery or C-section reported in medical record
- Number of newborns with low birth weight (<2500 grams)At birth
Number of newborns with low birth weight (\<2500 grams)
- Number of newborns with heart and circulation defectsAt birth
Number of newborns with heart and circulation defects reported in medical record
- Number of newborns with genital and urinary tract defectsAt birth
Number of newborns with genital and urinary tract defects reported in medical record
- Number of newborns with nervous system and eye defectsAt birth
Number of newborns with nervous system and eye defects reported in medical record
- Number of newborns with Club footAt birth
Number of newborns with Club foot reported in medical record
- Neonate mean body weight (kg)1 month
Neonate mean body weight (kg)
- Infant mean body weight (kg)12 months
Infant mean body weight (kg)
- Number of infants who sit unattended or without support12 months
Number of infants who sit unattended or without support from medical record
- Number of infants who pick up small objects with thumb-finger grasp12 months
Number of infants who pick up small objects with thumb-finger grasp from medical record
- Number of infants who say "Dada" or "Mama" nonspecifically12 months
Number of infants who say "Dada" or "Mama" nonspecifically from medical record
- Number of infants who look for dropped objects or objects hidden by parents12 months
Number of infants who look for dropped objects or objects hidden by parents from medical record
- Neonate mean body length (cm)1 month
Neonate mean body length (cm)
- Neonate mean head circumference (cm)1 month
Neonate mean head circumference (cm)
- Infant mean recumbent weight (kg)12 months
Infant mean recumbent weight (kg)
- Infant mean weight-for-length ratio (kg/cm)12 months
Infant mean weight (kg) divided by body length (cm)