- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07850141
Prospective Registry of Exposure to Gepotidacin (PREG)
Prospective Registry of Exposure to Gepotidacin (PREG): a Prospective Registry of Women and Their Offspring Exposed to Gepotidacin During Pregnancy
The purpose of this study is to monitor pregnancies exposed to gepotidacin and to evaluate possible teratogenic effects or birthweight-lowering effects of this medication relative to the primary outcomes of major congenital malformations (MCMs) and small for gestational age (SGA), as well as to evaluate secondary maternal, fetal, and infant outcomes.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: US GSK Clinical Trials Call Center
- Номер телефона: 877-379-3718
- Электронная почта: GSKClinicalSupportHD@gsk.com
Учебное резервное копирование контактов
- Имя: EU GSK Clinical Trials Call Center
- Номер телефона: +44 (0) 20 89904466
- Электронная почта: GSKClinicalSupportHD@gsk.com
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Pregnant participants with uncomplicated urinary tract infection who are exposed to gepotidacin or standard-of-care antibiotics during the relevant exposure window.
Описание
Inclusion Criteria:
For Both cohorts:
- Participants with aged 15 to 50 years
- United States resident
- Currently pregnant
- Participants personally signed and dated informed consent document or, upon waiver of written consent by the relevant Institutional review board (IRB), verbal consent indicating that the participant (or a legally acceptable representative) has been informed of all pertinent aspects of the study
- Authorization and contact information for the reporter (e.g., participant, maternal/infant Health care provider (HCP), prescriber) to allow for follow-up
Exposed cohort:
• Exposed to gepotidacin at any time during pregnancy or the relevant exposure window
Comparator cohort:
- Diagnosis of and treatment for uUTI at any time during pregnancy or the relevant comparator product exposure window
- Exposed to one or more American College of Obstetricians and Gynecologists (ACOG)-recommended treatments for acute cystitis at any time during pregnancy or the relevant comparator product exposure window
Exclusion Criteria:
For Both cohorts:
• Diagnosis of known MCMs for the index pregnancy prior to enrollment
Exposed cohort:
• None
Comparator cohort:
• Exposure to gepotidacin at the time of enrollment
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
Exposed cohort
Pregnant participants with uncomplicated urinary tract infection (uUTI) who are exposed to gepotidacin during the relevant exposure window |
Not Applicable since Observational Study
Другие имена:
|
|
Comparator cohort
Pregnant participants with uncomplicated urinary tract infection (uUTI) who are exposed to standard-of-care antibiotics during the relevant exposure window |
Not Applicable since Observational Study
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Number of infants with major congenital malformations (MCMs)
Временное ограничение: At pregnancy outcome, with follow-up through 12 months after delivery
|
An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention. |
At pregnancy outcome, with follow-up through 12 months after delivery
|
|
Number of infants with small-for-gestational-age births (SGA)
Временное ограничение: At live birth
|
A newborn infant whose birth weight is less than (<) 10th percentile for sex and gestational age using standard growth charts for full- and preterm live-born infants. |
At live birth
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Number of infants with minor congenital malformations
Временное ограничение: At live Birth, with follow-up up through 12 months of age
|
An anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e., birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual. |
At live Birth, with follow-up up through 12 months of age
|
|
Number of participants (pregnant women) with pregnancy termination
Временное ограничение: From date of conception (DOC) to <20 gestational weeks
|
A voluntary fetal loss or interruption of pregnancy that occurs for any reason, including but not limited to for the preservation of maternal health or because of fetal abnormalities. |
From date of conception (DOC) to <20 gestational weeks
|
|
Number of participants (pregnant women) with spontaneous abortions (SAB)
Временное ограничение: From date of conception (DOC) to <20 gestational weeks
|
An involuntary fetal loss or the expulsion of the products of conception occurring at less than (<) 20 gestational weeks. |
From date of conception (DOC) to <20 gestational weeks
|
|
Number of participants (pregnant women) with stillbirths
Временное ограничение: From 20 weeks' gestation to pregnancy outcome
|
Stillbirth is defined by the American College of Obstetricians and Gynecologists (ACOG), an involuntary fetal loss occurring at greater than or equal to (>=) 20 weeks of gestation, or, if gestational age is unknown, a fetus weighing >=350 grams. |
From 20 weeks' gestation to pregnancy outcome
|
|
Number of participants (pregnant women) with preeclampsia
Временное ограничение: From 20 weeks' gestation to pregnancy outcome
|
Preeclampsia is disorder of pregnancy associated with new-onset hypertension, which occurs most often after 20 weeks of gestation and frequently near term, and proteinuria, or, in the absence of proteinuria, it is defined as new-onset hypertension with the new onset of any of the following: Thrombocytopenia: platelet count <100,000/milliliter (mL). Renal insufficiency: serum creatinine concentrations >1.1 milligram per deciliter (mg/dL) or a doubling of the serum creatinine concentration in the absence of other renal disease. Impaired liver function: elevated blood concentrations of liver transaminases to twice the normal concentration. Pulmonary edema. New-onset headache unresponsive to medication and not accounted for by alternative diagnoses or visual symptoms |
From 20 weeks' gestation to pregnancy outcome
|
|
Number of participants (pregnant women) with eclampsia
Временное ограничение: From 20 weeks' gestation to pregnancy outcome
|
New-onset tonic-clonic, focal, or multifocal seizures in the absence of other causative conditions such as epilepsy, cerebral arterial ischemia and infarction, intracranial hemorrhage, or drug use. |
From 20 weeks' gestation to pregnancy outcome
|
|
Number of participants (pregnant women) with gestational hypertension
Временное ограничение: From 20 weeks' gestation to pregnancy outcome
|
Blood pressure greater than 140 millimeter of mercury (mmHg) systolic or 90 mmHg diastolic on 2 separate occasions at least 4 hours apart after 20 weeks of pregnancy when previous blood pressure was normal. |
From 20 weeks' gestation to pregnancy outcome
|
|
Number of participants (pregnant women) with gestational diabetes
Временное ограничение: At pregnancy outcome
|
Any degree of glucose intolerance with onset or first recognition during pregnancy. |
At pregnancy outcome
|
|
Number of participants (pregnant women) with preterm births
Временное ограничение: At live birth, if occurring before 37 gestational weeks
|
Preterm birth is defined as a live birth occurring at <37 gestational weeks. |
At live birth, if occurring before 37 gestational weeks
|
|
Number of infants with postnatal growth deficiency
Временное ограничение: At 4 and 12 months of infant age
|
Weight, length, or head circumference in <10th percentile for sex and chronological age using standard growth charts |
At 4 and 12 months of infant age
|
|
Number of infants with developmental delay
Временное ограничение: At 4 and 12 months of infant age
|
Failure to achieve the developmental milestones for chronological age, as defined by the Centers for Disease Control and Prevention. |
At 4 and 12 months of infant age
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: GSK Clinical Trials, GlaxoSmithKline
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Урогенитальные заболевания
- Генитальные заболевания
- Патологические процессы
- Мужские мочеполовые заболевания
- Урологические заболевания
- Женские урогенитальные заболевания
- Женские мочеполовые заболевания и осложнения беременности
- Атрибуты болезни
- Инфекции
- Передающиеся заболевания
- Патологические состояния, признаки и симптомы
- Заболевания, передающиеся половым путем
- Инфекция мочеиспускательного канала
- Следственные методы
- Методы
- Наблюдение
Другие идентификационные номера исследования
- 300392
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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