Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial
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: Azithromycin Injection, Placebo, Standard of Care Preoperative antibiotics.
- Кому может быть актуально
- Состояния в реестре: Obstetrical Complications, Labor and Delivery Complication, Cesarean Delivery. 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
- 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
Azithromycin Prophylaxis for Prelabor Cesarean Delivery Trial
Обзор
This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either adjunctive azithromycin prophylaxis or to placebo. Both groups also will receive standard of care preoperative antibiotics (excluding azithromycin). The primary endpoint is a maternal infection composite defined as any one of the following up to 6 weeks postpartum: endometritis, wound infection, abscess, septic thrombosis, sepsis, pneumonia, pyelonephritis and breast infection.
Подробное описание
This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either azithromycin prophylaxis or to placebo. All participants will receive standard of care preoperative antibiotics. The primary objective is to evaluate in patients undergoing scheduled/prelabor cesarean if pre-incision adjunctive azithromycin prophylaxis reduces the risk of post-cesarean infections compared with placebo. Secondary objectives include 1) to assess the perinatal and maternal safety of pre-incision adjunctive azithromycin, 2) to evaluate whether adjunctive azithromycin prophylaxis reduces maternal and neonatal resource use outcomes compared with placebo, and 3) to evaluate whether adjunctive azithromycin influences maternal and neonatal infection with resistant organisms compared with placebo.
Individuals will be randomized prior to the start of the cesarean to either 500mg of intravenous azithromycin or to placebo (normal saline). Maternal blood and cord blood will be collected on a subset of the population. Research staff will abstract maternal and neonatal outcomes following delivery and discharge from the hospital. A single maternal follow-up study visit at 6 weeks (4-8 weeks) postpartum will be scheduled to ascertain maternal and neonatal outcomes.
Вмешательства
- Препарат Azithromycin Injection
500mg azithromycin in 250 mL of normal saline - Препарат Placebo
250 mL of normal saline - Препарат Standard of Care Preoperative antibiotics
standard of care preoperative antibiotics (excluding azithromycin) prior to incision
Первичные конечные точки
- Maternal infection composite [Срок оценки: Delivery up to 6 weeks postpartum (a period of up to 6 weeks)]
Вторичные конечные точки (11)
- Non-infections wound complications [Срок оценки: Delivery up to 6 weeks postpartum (a period of up to 6 weeks)]
- Perinatal composite outcome [Срок оценки: hospital discharge, 6 weeks of birth, or death (whichever occurs first)]
- Number of neonates with Allergic Reaction [Срок оценки: birth through hospital discharge, or 7 days from birth, whichever is earliest]
- Number of Neonates with Gastrointestinal Symptoms [Срок оценки: birth through hospital discharge, or 7 days from birth, whichever is earliest]
- Number of Maternal Deaths [Срок оценки: From randomization through 6 weeks postpartum (a period of up to 6 weeks)]
- Maternal Resource Composite [Срок оценки: From hospital discharge following delivery through 6 weeks postpartum (a period of up to 6 weeks)]
- Neonatal Resource Composite [Срок оценки: From hospital discharge following delivery through 6 weeks postpartum (a period of up to 6 weeks)]
- Maternal Hospital Length of Stay [Срок оценки: Hospital admission to hospital discharge (up to 42 days)]
- Rate of Neonatal ICU Admission [Срок оценки: Delivery to hospital discharge (up to 120 days)]
- Number of Participants with Maternal Resistant Infection [Срок оценки: Randomization through 6 weeks postpartum (a period of up to 6 weeks)]
- Number of Neonates with Neonatal Resistant Infection [Срок оценки: From birth up to 6 weeks of age]
Критерии участия
Критерии включения
- ≥ 23 weeks' gestation (ACOG dating criteria)
- Scheduled or prelabor cesarean delivery
- Singleton or twin gestation
Критерии исключения
- Allergy or contraindication to azithromycin or macrolide antibiotics, including those with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin
- Chorioamnionitis
- Bacterial infection (e.g., pyelonephritis) requiring ongoing antibiotic treatment after delivery
- Premature rupture of membranes (PROM) or labor (i.e., contractions with ongoing cervical change)
- Fetal demise or known major congenital anomaly
- Azithromycin treatment within 7 days
- Planned use of antimicrobial prophylaxis after delivery for any reason
- Known structural heart disease or active cardiomyopathy (current ejection fraction<40%)
- Known arrhythmia with QT prolongation or taking scheduled medications known to prolong the QT interval such that it would preclude the use of azithromycin
- Refusal or unable to obtain consent (e.g., language barrier)
- Participating in another intervention study that influences the primary outcome in this study
- Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, do not have to be excluded.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Профилактика
Центры проведения
США · 14 центров
- University of Alabama - Birmingham — Birmingham
- Regents of the University of California San Francisco — San Francisco
- Northwestern University — Chicago
- Columbia University — New York
- University of North Carolina - Chapel Hill — Chapel Hill
- Duke University — Durham
- Case Western Reserve University — Cleveland
- Ohio State University — Columbus
- … и ещё 6 центров
Идентификаторы
NCT: NCT06605118 · HD036801-PRECEDE · U01HD114634 · U24HD036801