Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic Version

Официальное название

Randomized Clinical Trial of the Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic Version

Обзор

External Cephalic Version (ECV) is a maneuver to modify fetal position in pregnant women with a non-cephalic presentation. Its objective is to achieve a cephalic presentation that allows for vaginal delivery with less risk than a vaginal breech delivery or a cesarean section. ECV is an effective technique to reduce the rate of cesarean sections and is recommended by the Spanish Society of Obstetrics and Gynecology (SEGO) and the World Health Organization (WHO) Cesarean Section Working Group. The WHO aims to reduce interventionism in childbirth globally and implement non-clinical measures to reduce the rate of unnecessary cesarean sections. Despite Propofol is a sedative agent commonly used by anesthesiologist in countless ambulatory procedures in obstetric anaesthesia, it has been little studied in ECV, and its effect has not been compared with other commonly used agents such as remifentanil or spinal analgesia. The Obstetric Anesthesiology Section of the Spanish Society of Anesthesiology and Resuscitation recommends the use of locoregional analgesia in ECV.

Подробное описание

This project involves a randomized clinical trial to compare the effect of sedation with propofol versus spinal analgesia in ECV. Therefore, the objectives of this study are:

* To compare the effect of sedation with Propofol on the success rate of ECV compared to spinal analgesia. * To compare the effect of sedation with Propofol on the rate of complications of ECV compared to spinal analgesia. * To compare the effect of sedation with Propofol on the length of hospital stay of ECV compared to spinal analgesia.

Locoregional analgesia requires a longer hospital stay than sedation with Propofol and may mask an early diagnosis of complications after ECV, such as placental abruption, which is identified in the initial stages by intense abdominal pain.

Вмешательства

• Препарат Sedation with propofol
  Sedation with propofol
• Препарат Spinal analgesia with bupivacaine
  Spinal analgesia with bupivacaine

Первичные конечные точки

• compare the success rate of external cephalic version [Срок оценки: Up to 24 months.]

Вторичные конечные точки (8)

• ECV (external cephalic version) complication rate when using Propofol as a sedative agent or spinal analgesia. [Срок оценки: Up to 24 months.]
• rate of emergency cesarean sections in the first 24 hours after the procedure when using Propofol as a sedative agent or spinal analgesia in ECV. [Срок оценки: Up to 24 months]
• postprocedural pain when Propofol is used as a sedative agent or spinal analgesia in ECV [Срок оценки: Up to 24 months]
• rate of clinically relevant hypotension (SBP <90 mmHg or a 20% decrease from baseline SBP) when using Propofol as a sedative agent or spinal analgesia in ECV [Срок оценки: Up to 24 months]
• rate of nausea or vomiting when using Propofol as a sedative agent or spinal analgesia in ECV. [Срок оценки: Up to 24 months]
• angle of progression of fetal presentation as a predictor of ECV success. [Срок оценки: Up to 24 months]
• angle of progression of fetal presentation as a predictor of complications of ECV. [Срок оценки: Up to 24 months]
• degree of tissue oxygenation of the placenta during ECV by analyzing a pilot sample with infrared spectroscopy (NIRS) [Срок оценки: Up to 24 months]

Критерии участия

Критерии включения

• Voluntary participation.
• Older than 18 years.
• Non-cephalic presentation.
• Desire to attempt a vaginal birth.
• Normal blood count and coagulation prior to the intervention

Критерии исключения

• Age under 18 years old.
• Multiple gestation.
• Cephalic presentation.
• Risk of fetal compromise.
• Unexplained active bleeding.
• Absolute contraindication for vaginal delivery (Placenta Previa)
• 2 or more previous cesarean sections.
• Previous myomectomy with entry into the uterine cavity
• Maternal fever.
• Thrombocytopenia (<85,000 platelets).
• Maternal spinal anomaly.
• Intolerance or allergy to Propofol or any of its components.
• Intolerance or allergy to bupivacaine or any of its components.
• Contraindication for intrathecal sedation or analgesia

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

Испания · 1 центр

• Hospital Clínico Universitario Virgen de la Arrixaca — Murcia

Публикации

• Sanchez-Romero J, Falcon-Arana L, Blanco-Carnero JE, Garcia-Ferreira J, Herrera-Gimenez J, Fuentes-Garcia D, Araico-Rodriguez F, Gallego-Pozuelo RM, Nieto-Diaz A, de Paco-Matallana C. Randomized clinical trial of the use of Propofol as a sedative agent versus spinal analgesia with bupivacaine in External Cephalic Version (PropoSpinECV): study protocol for a randomized clinical trial. Trials. 2025 PMID 41068932

Идентификаторы

NCT: NCT06449430 · IMIB-ECV-2024-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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