跳至主要内容
临床试验/NCT07255014
NCT07255014已完成不适用

Impact of Epidural on Trauma of the Genital Tract During Peripartum

Tatiana Besse-Hammer1 个研究点 分布在 1 个国家目标入组 8,516 人开始时间: 2024年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8,516
试验地点
1
主要终点
Rate of peripartum genital tract trauma

研究概览

简要总结

Peripartum genital tract injuries (PVT) are common after vaginal delivery and can lead to physical, psychological, and functional sequelae. While several risk factors have been established in the literature, the link between epidural analgesia and these injuries remains controversial. The primary objective of this study was to evaluate the impact of epidural analgesia on the occurrence of PVT. Secondary objectives were to examine its association with instrumentation, episiotomy, and induction of labor, to identify independent risk factors for PVT, and to develop a predictive model for the risk of these injuries.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • •Vaginal delivery within the CHU Brugmann Hospital, from January 1 2020 till December 31 2002

排除标准

  • •Incomplete medical files
  • •Delivery before 25 weeks of pregnancy
  • •Out of Hospital delivery
  • •Medical termination of pregnancy (MTP)
  • •Cesarean delivery

结局指标

主要结局

Rate of peripartum genital tract trauma

时间窗: At delivery

Peripartum genital tract trauma is defined as any obstetric injury occurring during vaginal delivery, including perineal tears, episiotomies, and uterine ruptures.

Type of peripartum genital tract trauma

时间窗: At delivery

Distribution and severity of trauma (perineal tears from D1 to D4 according to OMS CIM-10 classification, D1 being superficial damage, versus episiotomies versus uterine ruptures).

次要结局

  • Instrumentation rate(At delivery)
  • Labor induction rate(At delivery)

研究者

发起方
Tatiana Besse-Hammer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tatiana Besse-Hammer

Head Physician of Clinical Trial Unit

Brugmann University Hospital

研究点 (1)

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