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临床试验/NCT04955418
NCT04955418已完成不适用

Effects of Epi-no Device on Perineal Preparation and Pelvic Floor Dysfunctions

Universidade Estadual de Londrina2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Effect of birth training with Epi-no

研究概览

简要总结

Perineal injury is the most common maternal obstetric complication associated with vaginal delivery. Perineal traumas are associated with maternal morbidity, including pain, urinary and fecal incontinence, genital prolapses, dyspareunia, physical and psychological impairment. EPI-NO is a device with the objective of preparing and training the pelvic floor for normal childbirth, this training allows smooth and slow movement along the perineal structures in the prenatal period, by causing a rapid traumatic laceration during childbirth. The objective of this study is to verify the effect of 10 pelvic stretching rows with Epi-No in preventing urinary incontinence and dyspareunia 6 months after delivery. The study group will consist of primiparous, over 18 years of age, between 30 and 32 weeks of gestation, will be evaluated before the intervention and 6 months after delivery. The control group will be evaluated only once, in the sixth month after delivery. The evaluation will consist of: anamnesis, physical examination (vaginal examination and palpation), perineometry, International Urinary Incontinence Questionnaire (ICIQ-UISF), Visual Analogue Scale for dyspareunia; Questionnaire for assessing dyspareunia Female Sexual Function Index (FSFI). Pregnant women referred for intervention will perform 10 sessions (twice a week for 5 weeks) of perineal preparation with the Epi-No device. It is expected at the end of the study to prove the effectiveness of the effect of 10 pelvic lengthening graft with Epi-No in relation to the degrees of laceration and episiotomy and, consequently, reduction of urinary incontinence and dyspareunia.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • primiparous
  • single fetus

排除标准

  • Patients with complaints of urinary incontinence during or before pregnancy
  • hypertension and gestational diabetes
  • placenta previa
  • twin pregnancy
  • multiparous
  • patients who had undergone perineal or vaginal surgery
  • patients who had urinary tract infection, genital herpes or ongoing candidiasis
  • And any other diagnosis in which pregnancy becomes at risk.

结局指标

主要结局

Effect of birth training with Epi-no

时间窗: 6 months after delivery

Comparison the frequency of perineal tears and episiotomy between women who underwent 10 sessions of Epi-No in the pre-delivery period with women who did not undergo treatment.

次要结局

  • Incidence of urinary incontinence and dyspareunia(6 months after delivery)
  • Incidence of dyspareunia(6 months after delivery)
  • Pelvic floor muscle strength(6 months after delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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