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

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• Number of pregnant females with high blood pressure — Through 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 nausea — Through study completion, an average of 40 weeks
  Number of pregnant females with severe nausea reported in medical record
• Number of pregnant females with vomiting — Through study completion, an average of 40 weeks
  Number of pregnant females with vomiting reported in medical record
• Number of pregnant females with dehydration — Through 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 gain — Through 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 infections — Through 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 bleeding — Through study completion, an average of 40 weeks
  Number of pregnant females with vaginal bleeding reported in medical record
• Number of pregnant females with abruptio placenta — Through study completion, an average of 40 weeks
  Number of pregnant females with abruptio placenta reported in medical record
• Number of pregnant females with placenta previa — Through 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 membranes — Through 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 labor — Through study completion, an average of 40 weeks
  Number of pregnant females with preterm labor reported in medical record
• Number of pregnant females with ectopic pregnancy — Through study completion, an average of 40 weeks
  Number of pregnant females with ectopic pregnancy reported in medical record
• Number of pregnant females with molar pregnancy — Through study completion, an average of 40 weeks
  Number of pregnant females with molar pregnancy reported in medical record
• Number of pregnant females who died — Through study completion, an average of 40 weeks
  Number of pregnant females who died reported in medical record
• Number of pregnant females with spontaneous abortions/miscarriage — Up to 20 weeks
  Number of pregnant females with spontaneous abortions/miscarriage reported in medical record
• Number of pregnant females with elective terminations — Through study completion, an average of 40 weeks
  Number of pregnant females with elective terminations reported in medical record
• Number of fetal deaths/stillbirths — From 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 births — Through 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-section — Through 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 defects — At birth
  Number of newborns with heart and circulation defects reported in medical record
• Number of newborns with genital and urinary tract defects — At birth
  Number of newborns with genital and urinary tract defects reported in medical record
• Number of newborns with nervous system and eye defects — At birth
  Number of newborns with nervous system and eye defects reported in medical record
• Number of newborns with Club foot — At 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 support — 12 months
  Number of infants who sit unattended or without support from medical record
• Number of infants who pick up small objects with thumb-finger grasp — 12 months
  Number of infants who pick up small objects with thumb-finger grasp from medical record
• Number of infants who say "Dada" or "Mama" nonspecifically — 12 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 parents — 12 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)

Trial sites (1)

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