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临床试验/NCT03108170
NCT03108170已完成不适用

Digital Perineal Massage and Pelvic Floor Muscle Exercise as an Antenatal Program for Prevention of Perineal Trauma in Elderly Women, a Randomized Controlled Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年4月12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
Proportion of participants who have perineal tears

研究概览

简要总结

Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage. They will be also educated to do pelvic floor muscle exercises and will receive the usual education program for strengthening the pelvic floor. The second group will receive the usual education program for strengthening the pelvic floor. Occurrence of perineal laceration will be reported at time of delivery.

详细描述

Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage. They will be also educated to do pelvic floor muscle exercises and will receive the usual educational pelvic floor dysfunction prevention program for strengthening the pelvic floor. The second group will receive the usual education program for strengthening the pelvic floor. Occurrence of perineal laceration will be reported at time of delivery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Pregnant women ≥ 35 years old
  • Primigravida or multi gravida

排除标准

  • History of chronic constipation
  • History of chronic cough
  • Current or past urinary or anal incontinence
  • History of genital prolapse before pregnancy
  • History of neuromuscular disorders or connective tissue disorders
  • History of medical disorders
  • History of preterm or precipitate labour
  • History of premature preterm rupture of membranes.
  • Genital infections

结局指标

主要结局

Proportion of participants who have perineal tears

时间窗: At 15 minutes from delivery

Proportion of perineal tears will be assessed by an investigator who will attend the participant delivery

次要结局

  • Proportion of participants who need episiotomy at time of delivery(At 15 minutes from delivery)
  • Duration of the second stage of labour(At 15 minutes from delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eman Omran

Principal investigator

Cairo University

研究点 (2)

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