2024-510701-29-00招募中4 期
Randomized Clinical Trial of the use of Propofol as a sedative agent versus spinal analgesia with bupivacaine in External Cephalic Version (PropoSpinECV)
Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2024年5月20日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- The primary end point is the ECV outcome.
研究概览
简要总结
The main objective of the project is to compare the success rate of ECV when used Propofol as a sedative agent or spinal analgesia.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Voluntary participation.
- •Older than 18 years
- •Non-cephalic presentation.
- •Desire to attempt a vaginal birth.
- •Normal blood count and coagulation prior to the intervention
排除标准
- •Age under 18 years old.
- •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
- •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.
结局指标
主要结局
The primary end point is the ECV outcome.
The primary end point is the ECV outcome.
次要结局
- Secondary outcome variables are complications of ECV, urgent cesarean section during the first 24 hours after the procedure, VAS scale, postoperative pain survey, clinically relevant hypotension, nausea, vomiting.
研究者
María Muñoz García
Scientific
Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
研究点 (1)
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