NCT02427009终止不适用
Effectiveness of Maintaining a Prone Position After Use of an Epidural Blood Patch for the Treatment of Post-dural Puncture Headache
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2015年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Headache recurrence: yes/no
研究概览
简要总结
The main objective of this study is to assess the rate of recurrence of headache following a first blood patch where patients will be positioned in the prone position for an hour after each blood patch needed during this study.
详细描述
The secondary objectives of this study are to:
A. To evaluate the number of blood patches needed for each patient during her hospital stay B. Assessing the intensity of all headaches every 24H C. Evaluate the complications occurring during the hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient was informed about the implementation of the study, its objectives, constraints and patient rights
- •The patient has signed the informed consent
- •The patient must be affiliated or beneficiary of a health insurance plan
- •The patient is available for follow up concerning her hospital stay
- •The patient has a post-dural puncture headache after a vaginal delivery. The diagnosis of post-puncture headache is retained on the basis of a frankly postural character for the headache, triggered or exacerbated by orthostatic position and relieved by recumbency.
- •The patient has an indication for a blood patch
排除标准
- •The patient is participating in another interventional study, with the exception of the following studies: Papillo PMA (2013-A00538-37); DG-Postpartum (2013-A00277-38); ElastoMAP (2013-A01148-37); ElastoDéclench (2014-A00828-39); LXRs(2009-A00968-49); OASIS II (2013-A00773-42); GrossPath (2014-A01120-47).
- •The patient is in an exclusion period determined by a previous study
- •The patient is under guardianship, curatorship or under judicial protection
- •The patient refuses to sign the consent
- •It is not possible correctly inform the patient
- •The patient is pregnant
- •The patient has a contra-indication (or an incompatible combination therapy) for a necessary treatment in this study
- •The patient was delivered by cesarean section
结局指标
主要结局
Headache recurrence: yes/no
时间窗: 72 hours after first blood patch
Headache recurrence defined by: presence of headaches that confine the mother to bed or affect her ability to take care of her baby
次要结局
- The number of blood patches required for each patient(Hospital discharge (expected average of 7 days))
- Visual analog scale for pain(72 hours after blood patch)
- In case of recurrence of headache following the 1st blood patch, the presence / absence of the following accompanying symptoms: nausea; vomiting; dizziness; tinnitus; diplopia; photophobia; low back pain.(During hospital stay (expected average of 7 days))
- Presence/absence of complications(During hospital stay (expected average of 7 days))
研究者
研究点 (2)
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