Идёт набор NCT05285735

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

— Наблюдательное Pregnancy Malaria

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Pregnancy, Malaria. Базовые параметры: 15 лет — 100 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

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.

Подробное описание

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.

Первичные конечные точки

Number of pregnant females with high blood pressure [Срок оценки: Through study completion, an average of 40 weeks]
Number of pregnant females with severe nausea [Срок оценки: Through study completion, an average of 40 weeks]
Number of pregnant females with vomiting [Срок оценки: Through study completion, an average of 40 weeks]
Number of pregnant females with dehydration [Срок оценки: Through study completion, an average of 40 weeks]
Number of pregnant females with diabetes (newly occurring) [Срок оценки: Through study completion, an average of 40 weeks]
Number of pregnant females with obesity/marked weight gain [Срок оценки: Through study completion, an average of 40 weeks]
Number of pregnant females with anemia (newly occurring) [Срок оценки: Through study completion, an average of 40 weeks]
Number of pregnant females with kidney or bladder infections [Срок оценки: Through study completion, an average of 40 weeks]
Number of pregnant females with vaginal bleeding [Срок оценки: Through study completion, an average of 40 weeks]
Number of pregnant females with abruptio placenta [Срок оценки: Through study completion, an average of 40 weeks]

Критерии участия

Критерии включения

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