- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07861633
Cesarean Anesthesia Blood Gas
Effects of Spinal and General Anesthesia Techniques on Maternal-Fetal Blood Gas Gradients and Fetal Carboxyhemoglobin Levels in Cesarean Delivery: A Prospective Observational Cohort Study
This prospective observational cohort study will evaluate maternal and fetal blood gas parameters in women undergoing cesarean delivery under spinal or general anesthesia. Maternal venous blood samples will be obtained immediately before anesthesia induction, and umbilical arterial blood samples will be obtained after delivery and cord clamping. Blood gas parameters, including pH, pCO2, pO2, bicarbonate, base excess, lactate, and fetal carboxyhemoglobin levels, will be compared between the spinal and general anesthesia groups. The study will also evaluate maternal-fetal blood gas gradients, Apgar scores, neonatal intensive care requirements, and the relationship between smoking exposure and fetal carboxyhemoglobin levels.
Обзор исследования
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Ali KAHVECİOĞLU, MD
- Номер телефона: +90 5549134317
- Электронная почта: ali.kahveci92@gmail.com
Места учебы
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-
Istanbul
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Istanbul, Istanbul, Турция (Туркие), 59050
- Рекрутинг
- Bağcılar Training and Research Hospital
-
Контакт:
- Ali KAHVECİOĞLU, MD
- Номер телефона: +90 5549134317
- Электронная почта: ali.kahveci92@gmail.com
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Pregnant women undergoing cesarean delivery at the Obstetrics and Gynecology Clinic of Bagcilar Training and Research Hospital. The study is a prospective observational cohort comparing maternal and fetal blood gas parameters and fetal carboxyhemoglobin levels according to the observed anesthesia technique (spinal or general anesthesia).
Описание
Inclusion Criteria:
- Adult women undergoing cesarean delivery at the study center.
- Patients receiving spinal or general anesthesia for cesarean delivery.
Exclusion Criteria:
- Patients who are not eligible for participation according to the study protocol.
- Patients in whom spinal anesthesia is converted to general anesthesia because of inadequate spinal block and pain during surgery.
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
Spinal Anesthesia
Participants undergoing cesarean delivery who receive spinal anesthesia as the anesthesia technique. |
Observed anesthesia technique in women undergoing cesarean delivery. Participants received either spinal anesthesia or general anesthesia as part of routine clinical care; the anesthesia technique was not assigned by the study. |
|
General Anesthesia
Participants undergoing cesarean delivery who receive general anesthesia as the anesthesia technique. |
Observed anesthesia technique in women undergoing cesarean delivery. Participants received either spinal anesthesia or general anesthesia as part of routine clinical care; the anesthesia technique was not assigned by the study. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Umbilical artery pH
Временное ограничение: Immediately after delivery
|
Umbilical arterial pH measured after delivery and cord clamping. |
Immediately after delivery
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Maternal venous pH
Временное ограничение: Immediately before anesthesia induction
|
Maternal venous pH measured immediately before anesthesia induction. |
Immediately before anesthesia induction
|
|
Umbilical artery pCO2
Временное ограничение: Immediately after delivery
|
Umbilical arterial pCO2 measured after delivery and cord clamping. |
Immediately after delivery
|
|
Umbilical artery pO2
Временное ограничение: Immediately after delivery
|
Umbilical arterial pO2 measured after delivery and cord clamping. |
Immediately after delivery
|
|
Maternal venous pCO2
Временное ограничение: Immediately before anesthesia induction
|
Maternal venous pCO2 measured immediately before anesthesia induction |
Immediately before anesthesia induction
|
|
Maternal venous pO2
Временное ограничение: Immediately before anesthesia induction
|
Maternal venous pO2 measured immediately before anesthesia induction |
Immediately before anesthesia induction
|
|
Umbilical artery HCO3
Временное ограничение: Immediately after delivery
|
Umbilical arterial bicarbonate measured after delivery and cord clamping. |
Immediately after delivery
|
|
Maternal venous HCO3
Временное ограничение: Immediately before anesthesia induction
|
Maternal venous bicarbonate measured immediately before anesthesia induction |
Immediately before anesthesia induction
|
|
Umbilical artery BE
Временное ограничение: Immediately after delivery
|
Umbilical arterial base excess measured after delivery and cord clamping |
Immediately after delivery
|
|
Maternal venous BE
Временное ограничение: Immediately before anesthesia induction
|
Maternal venous base excess measured immediately before anesthesia induction |
Immediately before anesthesia induction
|
|
Umbilical artery lactate
Временное ограничение: Immediately after delivery
|
Umbilical arterial lactate measured after delivery and cord clamping |
Immediately after delivery
|
|
Maternal venous lactate
Временное ограничение: Immediately before anesthesia induction
|
Maternal venous lactate measured immediately before anesthesia induction |
Immediately before anesthesia induction
|
|
Umbilical artery FCOHb
Временное ограничение: Immediately after delivery
|
Fetal carboxyhemoglobin measured in umbilical arterial blood after delivery and cord clamping |
Immediately after delivery
|
|
Maternal venous FCOHb
Временное ограничение: Immediately before anesthesia induction
|
Maternal carboxyhemoglobin measured in venous blood immediately before anesthesia induction |
Immediately before anesthesia induction
|
|
Maternal-fetal pH gradient (ΔpH)
Временное ограничение: Immediately after delivery
|
Difference between maternal venous pH and umbilical arterial pH |
Immediately after delivery
|
|
Maternal-fetal pCO2 gradient (ΔpCO2)
Временное ограничение: Immediately after delivery
|
Difference between maternal venous pCO2 and umbilical arterial pCO2 |
Immediately after delivery
|
|
Maternal-fetal lactate gradient (Δlactate)
Временное ограничение: Immediately after delivery
|
Difference between maternal venous lactate and umbilical arterial lactate |
Immediately after delivery
|
|
Apgar score at 1 minute
Временное ограничение: 1 minute after birth
|
Apgar score assessed 1 minute after birth using the Apgar score (range, 0-10), with higher scores indicating better neonatal condition. |
1 minute after birth
|
|
Apgar score at 5 minutes
Временное ограничение: 5 minutes after birth
|
Apgar score assessed 5 minutes after birth using the Apgar score (range, 0-10), with higher scores indicating better neonatal condition. |
5 minutes after birth
|
|
Neonatal intensive care unit admission
Временное ограничение: During the immediate neonatal period
|
Requirement for admission to the neonatal intensive care unit after birth |
During the immediate neonatal period
|
|
Neonatal intubation
Временное ограничение: During the immediate neonatal period
|
Requirement for endotracheal intubation after birth |
During the immediate neonatal period
|
|
Maternal hypotension requiring treatment
Временное ограничение: From anesthesia induction until the end of surgery
|
Occurrence of maternal hypotension requiring pharmacologic treatment during cesarean delivery |
From anesthesia induction until the end of surgery
|
|
Maternal vasopressor requirement
Временное ограничение: From anesthesia induction until the end of surgery
|
Requirement for vasopressor administration for management of maternal hypotension during cesarean delivery |
From anesthesia induction until the end of surgery
|
|
Smoking exposure and fetal FCOHb
Временное ограничение: Immediately after delivery
|
Association between maternal smoking exposure status and fetal carboxyhemoglobin level measured in umbilical arterial blood |
Immediately after delivery
|
Соавторы и исследователи
Следователи
- Главный следователь: Ali KAHVECİOĞLU, MD, University of Health Sciences, Bağcılar Training and Research Hospital
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
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
Другие идентификационные номера исследования
- E-10840098-50.04-4657
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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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