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

NCT05285735 | Recruiting

• 1 other identifier: IVAS 3851-1
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

Artesunate; Pregnancy Registry

Outcome Measures

Primary Outcomes (37)

• Number of pregnant females with high blood pressure

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

  Through study completion, an average of 40 weeks

• Number of pregnant females with severe nausea

  Number of pregnant females with severe nausea reported in medical record

  Through study completion, an average of 40 weeks

• Number of pregnant females with vomiting

  Number of pregnant females with vomiting reported in medical record

  Through study completion, an average of 40 weeks

• Number of pregnant females with dehydration

  Number of pregnant females with dehydration reported in medical record

  Through study completion, an average of 40 weeks

• Number of pregnant females with diabetes (newly occurring)

  Number of pregnant females with diabetes (newly occurring) reported in medical record

  Through study completion, an average of 40 weeks

• Number of pregnant females with obesity/marked weight gain

  Number of pregnant females with obesity/marked weight gain reported in medical record

  Through study completion, an average of 40 weeks

• Number of pregnant females with anemia (newly occurring)

  Number of pregnant females with anemia (newly occurring) reported in medical record

  Through study completion, an average of 40 weeks

• Number of pregnant females with kidney or bladder infections

  Number of pregnant females with kidney or bladder infections reported in medical record

  Through study completion, an average of 40 weeks

• Number of pregnant females with vaginal bleeding

  Number of pregnant females with vaginal bleeding reported in medical record

  Through study completion, an average of 40 weeks

• Number of pregnant females with abruptio placenta

  Number of pregnant females with abruptio placenta reported in medical record

  Through study completion, an average of 40 weeks

• Number of pregnant females with placenta previa

  Number of pregnant females with placenta previa reported in medical record

  Through study completion, an average of 40 weeks

• Number of pregnant females with premature rupture of membranes

  Number of pregnant females with premature rupture of membranes reported in medical record

  Through study completion, an average of 40 weeks

• Number of pregnant females with preterm labor

  Number of pregnant females with preterm labor reported in medical record

  Through study completion, an average of 40 weeks

• Number of pregnant females with ectopic pregnancy

  Number of pregnant females with ectopic pregnancy reported in medical record

  Through study completion, an average of 40 weeks

• Number of pregnant females with molar pregnancy

  Number of pregnant females with molar pregnancy reported in medical record

  Through study completion, an average of 40 weeks

• Number of pregnant females who died

  Number of pregnant females who died reported in medical record

  Through study completion, an average of 40 weeks

• Number of pregnant females with spontaneous abortions/miscarriage

  Number of pregnant females with spontaneous abortions/miscarriage reported in medical record

  Up to 20 weeks

• Number of pregnant females with elective terminations

  Number of pregnant females with elective terminations reported in medical record

  Through study completion, an average of 40 weeks

• Number of fetal deaths/stillbirths

  Number of fetal deaths/stillbirths reported in medical record

  From 20 weeks to study completion

• Number of premature live births (<37 weeks)

  Number of premature live births (\<37 weeks) reported in medical record

  Up to 37 weeks

• Number pregnant females with with live term births

  Number pregnant females with with live term births reported in medical record

  Through study completion, an average of 40 weeks

• Number of pregnant females with normal vaginal delivery or C-section

  Number of pregnant females with normal vaginal delivery or C-section reported in medical record

  Through study completion, an average of 40 weeks

• Number of newborns with low birth weight (<2500 grams)

  Number of newborns with low birth weight (\<2500 grams)

  At birth

• Number of newborns with heart and circulation defects

  Number of newborns with heart and circulation defects reported in medical record

  At birth

• Number of newborns with genital and urinary tract defects

  Number of newborns with genital and urinary tract defects reported in medical record

  At birth

• Number of newborns with nervous system and eye defects

  Number of newborns with nervous system and eye defects reported in medical record

  At birth

• Number of newborns with Club foot

  Number of newborns with Club foot reported in medical record

  At birth

• Neonate mean body weight (kg)

  Neonate mean body weight (kg)

  1 month

• Infant mean body weight (kg)

  Infant mean body weight (kg)

  12 months

• Number of infants who sit unattended or without support

  Number of infants who sit unattended or without support from medical record

  12 months

• Number of infants who pick up small objects with thumb-finger grasp

  Number of infants who pick up small objects with thumb-finger grasp from medical record

  12 months

• Number of infants who say "Dada" or "Mama" nonspecifically

  Number of infants who say "Dada" or "Mama" nonspecifically from medical record

  12 months

• Number of infants who look for dropped objects or objects hidden by parents

  Number of infants who look for dropped objects or objects hidden by parents from medical record

  12 months

• Neonate mean body length (cm)

  Neonate mean body length (cm)

  1 month

• Neonate mean head circumference (cm)

  Neonate mean head circumference (cm)

  1 month

• Infant mean recumbent weight (kg)

  Infant mean recumbent weight (kg)

  12 months

• Infant mean weight-for-length ratio (kg/cm)

  Infant mean weight (kg) divided by body length (cm)

  12 months

Eligibility Criteria

• Age: 15 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Amivas Inc.: lead

Study Sites (1)

4C Pharma Solutions

Piscataway, New Jersey, 08854, United States

RECRUITING

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Bryan Smith, MD

  Amivas Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrina Riggs

CONTACT

3017622609; kriggs@fastttrackresearch.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 21 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: March 18, 2022
• Study Start: June 8, 2022
• Primary Completion (Estimated): June 8, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)