Recruiting

Intravenous Artesunate

Sponsor:

Amivas Inc.

Code:

NCT05285735

Conditions

Pregnancy

Malaria

Eligibility Criteria

Sex: Female

Age: 15 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Pregnancy

Malaria

Study ID

NCT05285735

Start date

Jun 8, 2022

Status verified date

Jan, 2024

Completion date

Jul 1, 2029

Anticipated

Primary completion date

Jun 8, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 15 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Number of pregnant females with high blood pressure [ Time Frame: Through study completion, an average of 40 weeks ]
  • Number of pregnant females with severe nausea [ Time Frame: Through study completion, an average of 40 weeks ]
  • Number of pregnant females with vomiting [ Time Frame: Through study completion, an average of 40 weeks ]
  • Number of pregnant females with dehydration [ Time Frame: Through study completion, an average of 40 weeks ]
  • Number of pregnant females with diabetes (newly occurring) [ Time Frame: Through study completion, an average of 40 weeks ]
  • Number of pregnant females with obesity/marked weight gain [ Time Frame: Through study completion, an average of 40 weeks ]
  • Number of pregnant females with anemia (newly occurring) [ Time Frame: Through study completion, an average of 40 weeks ]
  • Number of pregnant females with kidney or bladder infections [ Time Frame: Through study completion, an average of 40 weeks ]
  • Number of pregnant females with vaginal bleeding [ Time Frame: Through study completion, an average of 40 weeks ]
  • Number of pregnant females with abruptio placenta [ Time Frame: Through study completion, an average of 40 weeks ]
  • Number of pregnant females with placenta previa [ Time Frame: Through study completion, an average of 40 weeks ]
  • Number of pregnant females with premature rupture of membranes [ Time Frame: Through study completion, an average of 40 weeks ]
  • Number of pregnant females with preterm labor [ Time Frame: Through study completion, an average of 40 weeks ]
  • Number of pregnant females with ectopic pregnancy [ Time Frame: Through study completion, an average of 40 weeks ]
  • Number of pregnant females with molar pregnancy [ Time Frame: Through study completion, an average of 40 weeks ]
  • Number of pregnant females who died [ Time Frame: Through study completion, an average of 40 weeks ]
  • Number of pregnant females with spontaneous abortions/miscarriage [ Time Frame: Up to 20 weeks ]
  • Number of pregnant females with elective terminations [ Time Frame: Through study completion, an average of 40 weeks ]
  • Number of fetal deaths/stillbirths [ Time Frame: From 20 weeks to study completion ]
  • Number of premature live births (<37 weeks) [ Time Frame: Up to 37 weeks ]
  • Number pregnant females with with live term births [ Time Frame: Through study completion, an average of 40 weeks ]
  • Number of pregnant females with normal vaginal delivery or C-section [ Time Frame: Through study completion, an average of 40 weeks ]
  • Number of newborns with low birth weight (<2500 grams) [ Time Frame: At birth ]
  • Number of newborns with heart and circulation defects [ Time Frame: At birth ]
  • Number of newborns with genital and urinary tract defects [ Time Frame: At birth ]
  • Number of newborns with nervous system and eye defects [ Time Frame: At birth ]
  • Number of newborns with Club foot [ Time Frame: At birth ]
  • Neonate mean body weight (kg) [ Time Frame: 1 month ]
  • Infant mean body weight (kg) [ Time Frame: 12 months ]
  • Number of infants who sit unattended or without support [ Time Frame: 12 months ]
  • Number of infants who pick up small objects with thumb-finger grasp [ Time Frame: 12 months ]
  • Number of infants who say "Dada" or "Mama" nonspecifically [ Time Frame: 12 months ]
  • Number of infants who look for dropped objects or objects hidden by parents [ Time Frame: 12 months ]
  • Neonate mean body length (cm) [ Time Frame: 1 month ]
  • Neonate mean head circumference (cm) [ Time Frame: 1 month ]
  • Infant mean recumbent weight (kg) [ Time Frame: 12 months ]
  • Infant mean weight-for-length ratio (kg/cm) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

4C Pharma Solutions

Recruiting

Piscataway, New Jersey, United States, 08854

Contacts

More Information

Sponsor

Amivas Inc.

Last update posted

Jan 30, 2024

Last verified

Jan, 2024

Keywords

  • Artesunate
  • Pregnancy Registry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Amivas Inc. on 2024-01-30.