跳至主要内容
临床试验/NCT03172286
NCT03172286Unknown不适用

Radiofrequency Technic's Impact on Perineal Postpartum Pain

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2017年4月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
62
试验地点
2
主要终点
Pain score using analogical pain scale

研究概览

简要总结

A study in the postpartum period reveals that among women who delivered vaginally and having perineal lesions, between 95 and 100% of them suffer from perineal pain (episiotomy, tears from 1st to 4th degree) to 24 hours of vaginal delivery; and between 60 and 91% 7 days after delivery.

Severe pain that is not taken into account can become chronic pain. It has physical and psychological consequences. It is therefore essential to prevent these risks in young mothers.

The main objective of this study is to assess the efficacy of radiofrequency treatment on perineal pain postpartum, after a vaginal delivery, instrumented or not, in patients with perineal lesions.

A double-blind randomized prospective single-center study will be conducted on patients delivering at Marseille's north hospital.

Women who gave birth to the North hospital site, with perineal lesions (tears, episiotomy) will be invited to enroll in the study.

Patients will be then randomized into two groups, one with radiofrequency treatment, the other without treatment with radiofrequency.

The duration of inclusion is provided over 6 months. Each topic will be followed over a period of 1 month. The total study duration is 7 months.

The expected results are a significant reduction in pain scores during the first days postpartum in women with perineal alteration caused by a vaginal delivery instrumented or not. Also an improvement in the quality of life of patients during the first days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients who naturaly delivered with ou without instruments such as Suction cup, spatulas, forceps
  • Patients presenting perineal lesions

排除标准

  • Patients who delivered through cesarean section

结局指标

主要结局

Pain score using analogical pain scale

时间窗: 30 minutes

Pain score will be assessed before and after the radiofrequencing cession

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验