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Набор скоро начнётся NCT07406841

Spinal Versus General Anesthesia in Pregnancies With Placenta Accreta Spectrum: A Retrospective Comparative Study

Наблюдательное Placenta Accreta Spectrum

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: spinal anesthesia, General Anesthesia.
Кому может быть актуально
Состояния в реестре: Placenta Accreta Spectrum. Базовые параметры: 18 лет — 45 лет · 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Comparison of Spinal and General Anesthesia on Maternal and Neonatal Outcomes in Pregnancies With Placenta Accreta Spectrum: A Retrospective Study

Обзор

Placenta accreta spectrum (PAS) is a serious pregnancy complication in which the placenta grows abnormally into the uterine wall. This condition is associated with a high risk of severe bleeding, need for blood transfusion, hysterectomy, and maternal complications during cesarean delivery. This study aims to compare spinal anesthesia and general anesthesia in pregnant women diagnosed with placenta accreta spectrum who underwent cesarean delivery. The researchers reviewed existing medical records to evaluate differences in maternal and neonatal outcomes between the two anesthesia approaches. The primary outcomes include changes in hemoglobin levels before and after surgery, the need for uterotonic medications during and after the operation, and newborn Apgar scores. Because this is a retrospective observational study, no new treatments were given, and all data were collected from routine clinical care records. The findings are expected to help guide anesthetic decision-making in PAS cases, improve maternal and neonatal safety, and contribute to the international scientific literature on this topic.

Подробное описание

This is a single-center, retrospective observational study conducted in pregnant patients diagnosed with placenta accreta spectrum (PAS) who underwent cesarean delivery at Gaziantep City Hospital. Medical records were reviewed to identify eligible cases between the predefined study period based on imaging findings, intraoperative diagnosis, and/or histopathological confirmation of PAS.

Patients were categorized according to the type of anesthesia received during cesarean delivery: spinal anesthesia or general anesthesia. The choice of anesthetic technique was based on routine clinical practice, multidisciplinary team decision, and individual patient characteristics, rather than random assignment. No additional interventions were introduced for research purposes.

Data were extracted from electronic medical records, anesthesia charts, obstetric files, and neonatal records. Collected variables included demographic characteristics, obstetric history, imaging findings suggestive of PAS, intraoperative management strategies, estimated blood loss, transfusion requirements, use of uterotonic agents, and perioperative hemodynamic parameters. Neonatal data included gestational age at delivery, birth weight, Apgar scores at 1 and 5 minutes, need for resuscitation, and admission to neonatal intensive care.

The primary analytic focus was the comparison of perioperative hemoglobin change between the spinal and general anesthesia groups. Secondary analyses evaluated differences in intraoperative and postoperative uterotonic requirements, transfusion needs, surgical complications, length of hospital stay, and neonatal outcomes.

Statistical analyses were performed using appropriate parametric or non-parametric tests depending on data distribution. Potential confounding factors such as placenta previa status, prior cesarean history, and PAS severity were considered in subgroup analyses.

Ethics approval was obtained from the Gaziantep City Hospital Clinical Research Ethics Committee prior to data collection, and patient confidentiality was maintained in accordance with national regulations and the Declaration of Helsinki.

Вмешательства

  • Процедура spinal anesthesia
    Spinal anesthesia administered for cesarean delivery as part of routine clinical care in pregnant patients with placenta accreta spectrum. The technique was chosen by the clinical team based on standard institutional practice and patient condition, not for research assignment.
  • Процедура General Anesthesia
    General anesthesia was administered for cesarean delivery in pregnant patients with placenta accreta spectrum as part of routine clinical care. The anesthetic technique, including airway management, induction agents, and maintenance strategy, was selected by the attending anesthesia team according to institutional standards and the patient's clinical condition. The intervention was not assigned for research purposes.

Первичные конечные точки

  • Length of Hospital Stay to Discharge [Срок оценки: Postoperative day of hospital discharge, assessed up to 30 days after cesarean delivery.]
  • Perioperative Hemoglobin Change [Срок оценки: From preoperative assessment to 48 hours after cesarean delivery]
  • Neonatal Apgar Score at 1 and 5 Minutes [Срок оценки: At 1 minute and 5 minutes after birth]

Критерии участия

Критерии включения

  • Pregnant patients diagnosed with placenta accreta spectrum (PAS), Undergoing elective cesarean delivery, Receiving either spinal anesthesia or general anesthesia during cesarean section, Singleton pregnancy, Availability of complete medical and anesthesia records related to surgery and perioperative management

Критерии исключения

Patients without a diagnosis of PAS, Emergency (non-elective) cesarean deliveries, Use of anesthesia techniques other than spinal or general anesthesia, Multiple pregnancy (twins or more) ,Incomplete or missing medical/anesthesia records, Missing key perioperative or neonatal outcome data

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07406841 · GZŞH-ANES-PAS-2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗