Long Term Outcomes of Parturients Suffering From a Post Dural Puncture Headache Following an Accidental Dural Puncture (PDPH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Post Traumatic Stress Disorder (PTSD) questionnaire score
研究概览
简要总结
Epidural analgesia is considered a gold standard method for treatment of labor pain. One of the major risks with epidural analgesia is an accidental dural puncture, which leads to a post dural puncture headache. This headache is associated with significant maternal morbidity and can result in severe maternal consequences.
Post traumatic stress disorder (PTSD) is defined as an anxiety syndrome, resulting from a traumatic experience. Postpartum PTSD, is a form of PTSD that can occur in relation to a traumatic birth experience. As PDPH is unexpected and can cause severe maternal sequele, PDPH can exhibit a posttraumatic stress response. Therefore we hypothesize that parturients who suffered from a PDPH are at higher risk for developing PP-PTSD.
To date, very few reports have examined the long term outcomes of parturients suffering from a PDPH. As a follow up to the national survey of PDPH management in Israel the investigators aim, in this prospective multi center, observational study, to evaluate the long term outcomes of parturients suffering from a PDPH, including chronic headache, backache, postpartum depression, decreased breastfeeding and the development of PP PTSD.
详细描述
Introduction:
Epidural analgesia is considered a gold standard method for treatment of labor pain . However one of the major risks with epidural analgesia is an accidental dural puncture, a common complication occurring in 0.4-6% of the obstetric population . ADP increases the risk of developing a post dural puncture headache (PDPH) in 50% of parturients. PDPH is defined as a postural headache that worsens within fifteen minutes of standing and is relieved in the supine position . PDPH results from a CSF leakage from the intrathecal space, causing a decrease in CSF volume and pressure .
PDPH is associated with significant maternal morbidity, prolonging hospital stay, preventing ambulation and impairing maternal neonatal bonding . Less frequently PDPH can cause severe maternal complications resulting in posterior reversible encephalopathic syndrome , pneumocephalus , or a subdural hematoma .
Treatment protocols for PDPH vary greatly, with numerous existing conservative/ invasive treatment options . Conservative treatment includes bed rest, fluids administration, non-steroidal anti-inflammatory drugs and caffeine intake. The most standard invasive method for treatment of PDPH with a reported success rate of 70-90% includes the epidural blood patch (EPD) which is applied by injecting autologous blood epidurally .
Several factors have been found to increase the risk for developing a PDPH and increasing the duration of a PDPH including young age, low BMI and previous history of anxiety or depression .
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All cases of parturients suffering from a PDPH during the years 2007-2017.
排除标准
- •Women unable to be answer a questionnaire in Hebrew. Women under the age 18 Women suffering from a PDPH following spinal anesthesia for cesarean section.
结局指标
主要结局
Post Traumatic Stress Disorder (PTSD) questionnaire score
时间窗: Up to ten years postpartum (Answer at telephone survey)
The total PTSD questionnaire score using the validated PTSD questionnaire
次要结局
- The total Edinburgh Postnatal Depression Scale (EPDS) questionnaire score(Up to ten years postpartum (Answer at telephone survey))
- The total score on the Brief Pain Inventory questionnaire(Up to ten years postpartum (Answer at telephone survey))
- The total score on the Oswestry low back pain questionnaire(Up to ten years postpartum (Answer at telephone survey))