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Набор скоро начнётся NCT05477953

An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health

— Наблюдательное Chagas Disease

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
В протоколе указаны: Nifurtimox (BAYA2502).
Кому может быть актуально
Состояния в реестре: Chagas Disease. Базовые параметры: Без ограничений · 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, Аргентина, Bolivia, Чили, Колумбия +7
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Observational Pregnancy Safety Study of Women Exposed to Nifurtimox During Pregnancy to Describe the Risk of Pregnancy and Maternal Complications and Other Events of Interest on the Developing Fetus, Neonate, and Infant

Обзор

This is an observational study in which data from women with Chagas disease who will take or have already taken nifurtimox during pregnancy and the impact on their babies are studied. Chagas disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. If Chagas disease is left untreated, it can later cause e.g. serious heart and digestive problems. Nifurtimox has been used for more than 50 years to treat Chagas disease in children and adults. It is not recommended to be used during pregnancy as data from animal studies indicate that it may harm the baby. Currently, there are not enough data to know if this is also the case in humans. In this study, researchers want to collect data on the safety of nifurtimox use in pregnant women. To do this, researchers will collect the following information: * Birth defects (abnormal and problematic structures or functions, a child is born with) * Pregnancy outcomes (like live birth, preterm birth, still birth/death of the unborn baby, miscarriage, or abortion) * Certain health problems of the child up to 12 months of age * Certain health problems of the women experienced during pregnancy The data will be collected from different sources including telephone calls with the women or their doctor, CRFs (case reprt forms) or from medical records The researchers will compare the proportion of children with birth defects, pregnancy outcomes or certain health problems of the child or the women during pregnancy with available data on these outcomes in the general population. The study will run for approximately 10 years.

Вмешательства

  • Препарат Nifurtimox (BAYA2502)
    At least 1 dose of nifurtimox

Первичные конечные точки

  • Major Congenital Malformations (birth defects) [Срок оценки: Up to pregnancy week 40]
Вторичные конечные точки (12)
  • Events of Interest in Neonates and Infants through 12 Months of Age: Hospitalizations for serious illness [Срок оценки: Up to 12 months of age]
  • Events of Interest in Neonates and Infants through 12 Months of Age: Medications [Срок оценки: Up to 12 months of age]
  • Events of Interest in Neonates and Infants through 12 Months of Age: Growth and development milestones [Срок оценки: Up to 12 months of age]
  • Events of Interest in Neonates and Infants through 12 Months of Age: Neonatal or infant mortality [Срок оценки: Up to 12 months of age]
  • Maternal Complications: Premature rupture of membranes (PROM) [Срок оценки: Up to pregnancy week 40]
  • Maternal Complications: Preeclampsia [Срок оценки: Up to pregnancy week 40]
  • Maternal Complications: Severe pregnancy-induced hypertension (PIH) [Срок оценки: Up to pregnancy week 40]
  • Maternal Complications: Proteinuria [Срок оценки: Up to pregnancy week 40]
  • Maternal Complications: Gestational diabetes [Срок оценки: Up to pregnancy week 40]
  • Maternal Complications: Measures of fetal growth deficiency (small for gestational age) [Срок оценки: Up to pregnancy week 40]
  • Spontaneous abortion [Срок оценки: Up to 20 weeks]
  • Elective/Induced abortion [Срок оценки: Up to pregnancy week 40]

Критерии участия

Критерии включения

  • Females exposed to at least 1 dose of nifurtimox at any time during pregnancy (i.e., from the first day of the last menstrual period / time of conception to pregnancy outcome).
  • Written informed consent (for adolescents under the age of majority, written informed assent by the pregnant minor (where applicable) and written informed consent by the parent/legal guardian).

Критерии исключения

  • None

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Many Locations — Multiple Locations
Аргентина · 1 центр
  • Many Locations — Multiple Locations
Bolivia · 1 центр
  • Many Locations — Multiple Locations
Чили · 1 центр
  • Many Locations — Multiple Locations
Колумбия · 1 центр
  • Many Locations — Multiple Locations
El Salvador · 1 центр
  • Many Locations — Multiple Locations
Германия · 1 центр
  • Many Locations — Multiple Locations
Guatemala · 1 центр
  • Many Locations — Multiple Locations
Honduras · 1 центр
  • Many locations — Multiple Locations
Мексика · 1 центр
  • Many Locations — Multiple Locations
Испания · 1 центр
  • Many Locations — Multiple Locations
Uruguay · 1 центр
  • Many Locations — Multiple Locations

Идентификаторы

NCT: NCT05477953 · 21944

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗