Sustained Cord Circulation at Emergency Cesarean Section
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: Sustained cord (≥ 180 seconds) resuscitation, Routine (< 60 seconds) cord clamping.
- Кому может быть актуально
- Состояния в реестре: Asphyxia Neonatorum, Fetal Hypoxia. Базовые параметры: 37 Weeks — 42 Weeks · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швеция
- 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
Sustained Cord Circulation at Emergency Cesarean Section - a New Concept for Resuscitating Neonates
Обзор
The goal of this clinical trial is to evaluate if sustained cord circulation during resuscitation improves outcomes for term neonates born by emergency Cesarean section. The main question it aims to answer is: Does sustained cord circulation reduce admission rates to neonatal care? Researchers will compare resuscitation with an uncut umblical cord to standard resuscitation practices to see if it provides better outcomes. Participants (term neonates born by emergency Cesarean section) will: Receive resuscitation with either sustained cord circulation or standard care Be monitored for admission to neonatal care and other predefined health outcomes
Подробное описание
Study Title
Sustained Cord Circulation During Resuscitation of Non-Breathing Neonates Born by Cesarean Section: A Multicenter Randomized Controlled Trial
Primary Objectives:
To compare neonatal outcomes between two different approaches to resuscitation of term neonates born by CS; Intact cord resuscitation versus standard care with immediate cord clamping, and evaluate:
A composite outcome of admission to neonatal care for predefined criteria or death before admission. Predefined criteria include asphyxia at birth, respiratory distress, hypoxic ischemic encephalopathy (HIE) and hypoglycemia. Assessed within one week after birth.
Secondary Objectives: Secondary outcomes will include short and long-term neonatal outcomes, adverse maternal and neonatal outcomes, and caregivers' and staff's experiences.
Study Design: A multicenter, stepped-wedge cluster randomized trial.
Study Population: Singleton neonate born alive, gestational age ≥37 weeks, born by emergency cesarean section, epidural/spinal anesthesia. Pediatric team summoned before birth due to health concerns regarding the neonate.
Intervention: Resuscitation with intact cord circulation during 3-5 minutes. When in need of respiratory support, the neonate will be kept close to the mother with the cord intact and the placenta attached to the uterine wall. The pediatric team will give respiratory support with sustained cord circulation, following Swedish neonatal CPR guidelines. Cord clamping will be performed after respiration has been established and at the earliest after three minutes. Cord clamping will be performed at the latest at 5 minutes.
Control: Resuscitation will be performed after the cord was cut. When in need of respiratory support, the cord will be clamped immediately, and the neonate will be taken to an adjacent place for resuscitation according to Swedish neonatal CPR guidelines. Well neonates will have their cord clamped after 1 minute in accordance with national recommendations.
Power analysis: At a significant level of 0.05, the power to detect the anticipated risk reduction (15%) would be 0.88 (two-sided).
Study Duration 2025-2028
Вмешательства
- Процедура Sustained cord (≥ 180 seconds) resuscitation
Resuscitation performed in near proximity to the mother with umbilical cord uncut - Процедура Routine (< 60 seconds) cord clamping
Resuscitation performed at a designated area after umbilical cord is cut
Первичные конечные точки
- Composite outcome of admission to neonatal care for predefined criteria and death before admission. [Срок оценки: At one hour after birth]
Вторичные конечные точки (7)
- Apgar score at 5 min [Срок оценки: 5 minutes]
- Apgar score at 10 min [Срок оценки: 10 minutes]
- Respiratory distress as a diagnosis after birth [Срок оценки: One week after birth]
- Hypoxic-ischemic encephalopathy as a diagnosis after birth [Срок оценки: One week after birth]
- Hypoglycemia as a diagnosis after birth [Срок оценки: One week after birth]
- Duration of neonatal care [Срок оценки: One month]
- Death after birth but before admission to neonatal unit [Срок оценки: One hour after birth]
Критерии участия
Критерии включения
- Singleton neonate
- Born alive
- Gestational age ≥37 weeks
- Born by emergency cesarean section, epidural/spinal anesthesia, where the pediatric/neonatal team has been called for to attend.
Критерии исключения
- Major congenital malformation that may affect resuscitation or outcome measures.
- Major genetic disorder that may affect resuscitation or outcome measures.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Швеция · 12 центров
- Östra sjukhuset - Sahlgrenska Universitetssjukhuset — Gothenburg
- Hallands sjukhus, Halmstad — Halmstad
- Universitetssjukhuset i Linköping — Linköping
- Skånes Universitetssjukhus — Lund
- Skånes Universitetssjukhus, Malmö — Malmö
- Universitetssjukhuset Örebro — Örebro
- BB Stockholm — Stockholm
- Danderyds sjukhus — Stockholm
- … и ещё 4 центра
Публикации
- Ekelof K, Saether E, Andersson O, Svedenkrans J, Linden K. pre-SUCCECS: Lessons learned from implementing resuscitation and stabilisation with an intact cord during caesarean sections - Focus group discussions with implementation teams. Sex Reprod Healthc. 2025 Sep;45:101114. doi: 10.1016/j.srhc.2025.101114. Epub 2025 May 26. PMID 40479951
- Alikhani VS, Thies-Lagergren L, Svedenkrans J, Elfvin A, Bolk J, Andersson O. Stabilisation and resuscitation with intact cord circulation is feasible using a wide variety of approaches; a scoping review. Acta Paediatr. 2023 Dec;112(12):2468-2477. doi: 10.1111/apa.16985. Epub 2023 Sep 28. PMID 37767916
Идентификаторы
NCT: NCT06540222 · SUCCECS · Dnr 2024-00276-01