Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05285735

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pregnancy Infections Malaria Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

15 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

4C Pharma Solutions

Piscataway, New Jersey, 08854, United States

Location status: Recruiting

Location contact

Ankur Joshi

CONTACT

[email protected]

732-529-6989

About this study

Pregnant women or physicians treating pregnant women with severe malaria with IV Artesunate will become aware of the Pregnancy Registry via the product label, the Amivas Inc. website, or her physician. By calling 1-855-526-4827 (1-855-5AMIVAS) or contacting www.amivas.com/our-products, the patient or physician will be connected to the Pregnancy Registry Call Center. In France, the Collaborating-Investigators conducting the ARTEMUM observatory study have a wide information campaign among obstetrical wards, neonatal wards, Infectious Diseases wards, intensive care units (ICU), and parasitology hospital laboratories, through expert networks of infectious diseases specialists, obstetricians and pediatricians in University hospitals from the Paris Area and suburbs that concentrate 50-55% of malaria cases in France. They also collaborate with the National Research Center (NRC) for malaria and will capture voluntary reports by clinicians and microbiologists in the NRC network.

When contact is made to the call center, a trained staff member will acquaint the patient or treating physician with the goals and procedures of the study. If the patient agrees to participate in the study over the telephone, the patient's verbal consent will be documented, and the patient will be sent the study Consent Form that includes the consent for the patient's physician/obstetrician and the child's pediatrician to release medical information via email. If a physician is contacting the Call Center, s/he may be provided with this form to review, and the physician will be directed to ask the patient to telephone the Call Center to provide consent. With the patient's consent, the patient's physician/obstetrician will be contacted by a Call Center staff member and will be interviewed by a trained call center healthcare professional/pharmacist for information about the patient including demographics, malaria history, history of treatment, and initial pregnancy data. The Call Center will contact the patient's physicians (including obstetrician and infant's pediatrician, as appropriate) each trimester until delivery, and also at birth and 1 year after birth, to collect data on maternal adverse events (AEs), pregnancy outcome, fetal outcome, and infant outcome. Patients consented in France under the ARTEMUM study will undergo the consent process by the treating Physician. Anonymized data will be prospectively collected by a research technician under the supervision of a local manager in France.

Data collected by the call center will be sent to the Coordinating Center on a monthly basis for review and tracking of participants, then annually for inclusion in the interim or final report. Data collected as part of the ARTEMUM study will be provided in aggregate as summary tables to be included in the annual report.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of pregnant females with high blood pressure

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

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

  2. Number of pregnant females with severe nausea

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

    Number of pregnant females with severe nausea reported in medical record

  3. Number of pregnant females with vomiting

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

    Number of pregnant females with vomiting reported in medical record

  4. Number of pregnant females with dehydration

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

    Number of pregnant females with dehydration reported in medical record

  5. Number of pregnant females with diabetes (newly occurring)

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

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

  6. Number of pregnant females with obesity/marked weight gain

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

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

  7. Number of pregnant females with anemia (newly occurring)

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

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

  8. Number of pregnant females with kidney or bladder infections

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

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

  9. Number of pregnant females with vaginal bleeding

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

    Number of pregnant females with vaginal bleeding reported in medical record

  10. Number of pregnant females with abruptio placenta

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

    Number of pregnant females with abruptio placenta reported in medical record

  11. Number of pregnant females with placenta previa

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

    Number of pregnant females with placenta previa reported in medical record

  12. Number of pregnant females with premature rupture of membranes

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

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

  13. Number of pregnant females with preterm labor

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

    Number of pregnant females with preterm labor reported in medical record

  14. Number of pregnant females with ectopic pregnancy

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

    Number of pregnant females with ectopic pregnancy reported in medical record

  15. Number of pregnant females with molar pregnancy

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

    Number of pregnant females with molar pregnancy reported in medical record

  16. Number of pregnant females who died

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

    Number of pregnant females who died reported in medical record

  17. Number of pregnant females with spontaneous abortions/miscarriage

    Time frame: Up to 20 weeks

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

  18. Number of pregnant females with elective terminations

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

    Number of pregnant females with elective terminations reported in medical record

  19. Number of fetal deaths/stillbirths

    Time frame: From 20 weeks to study completion

    Number of fetal deaths/stillbirths reported in medical record

  20. Number of premature live births (<37 weeks)

    Time frame: Up to 37 weeks

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

  21. Number pregnant females with with live term births

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

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

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

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

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

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

    Time frame: At birth

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

  24. Number of newborns with heart and circulation defects

    Time frame: At birth

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

  25. Number of newborns with genital and urinary tract defects

    Time frame: At birth

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

  26. Number of newborns with nervous system and eye defects

    Time frame: At birth

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

  27. Number of newborns with Club foot

    Time frame: At birth

    Number of newborns with Club foot reported in medical record

  28. Neonate mean body weight (kg)

    Time frame: 1 month

    Neonate mean body weight (kg)

  29. Infant mean body weight (kg)

    Time frame: 12 months

    Infant mean body weight (kg)

  30. Number of infants who sit unattended or without support

    Time frame: 12 months

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

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

    Time frame: 12 months

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

  32. Number of infants who say "Dada" or "Mama" nonspecifically

    Time frame: 12 months

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

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

    Time frame: 12 months

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

  34. Neonate mean body length (cm)

    Time frame: 1 month

    Neonate mean body length (cm)

  35. Neonate mean head circumference (cm)

    Time frame: 1 month

    Neonate mean head circumference (cm)

  36. Infant mean recumbent weight (kg)

    Time frame: 12 months

    Infant mean recumbent weight (kg)

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

    Time frame: 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Katrina Riggs

CONTACT

[email protected]

3017622609

Sponsors and collaborators

Lead sponsor

Amivas Inc.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Mar 18, 2022
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.