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临床试验/NCT04525846
NCT04525846已完成不适用

A Comparison of Urinary Incontinence During Third Trimester of Nulliparous on Pelvic Floor Muscle Training in Rajavithi Hospital

Department of Medical Services Ministry of Public Health of Thailand2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年8月23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
150
试验地点
2
主要终点
Urinary incontinence at third trimester both group

研究概览

简要总结

Comparison of urinary incontinence during third trimester of nulliparous on pelvic floor muscle training in Rajavithi hospital

详细描述

Outcomes

  1. primary outcome >> UI at third trimester
  2. secondary outcome >> quality of life, duration of second stage of labor
  • Inclusion criteria nulliparous GA 20-24 week gestation singleton Age 18-35 years old Can communicate and understand Thai language Cooperating to join research
  • Exclusion criteria DFIU Maternal medical condition or high risk pregnancy such as multifetal gestation, chronic hypertension, pregestational DM, epilepsy, autoimmune disease, polyhydramnios asthma
  • Pre-excisting urinary incontinence
  • prepregnancy BMI>=30 kg/m2
  • smoking
  • 2 groups study >> control and intervention group
  • Both groups were evaluated urinary incontinence(UI) at third trimester with UDI-6 and IIQ-7 questionaires
  • Intervention group was trianed pelvic floor muscle strength and evaluate strength with Brink score by researcher who was trained and tested pelvic floor muscle strength by urogynecologist at day 1 then reassess Brink score at 4 weeks
  • program of pelvic floor muscle training ( PFMT) consist of contract and whole pelvic floor muscle 10 seconds and relaxation 10 second total 20 times per set total 3 set per day
  • intervention group was followed up once a week by telephone about compliance of program, general symptom and notice for self recording sheet
  • PFMT program follow up total 12 weeks

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
None

入排标准

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

入选标准

  • nulliparous
  • gestational gae 20-24 week
  • age 18-35 year
  • can communicate and understand Thai language
  • co-operate to join research

排除标准

  • maternal medical condition or high risk pregnancy such as multifetal gestation , pregestational DM, chonic hypertension , epilepsy, autoimmune disease, polyhydramnios, asthma
  • pre-excisting urinary incontinence
  • prepregnant BMI >=30 kg/m2

结局指标

主要结局

Urinary incontinence at third trimester both group

时间窗: GA 36-38 wk

Use Questionaires Urinary Distress Inventory (UDI-6) include 6 domains( Frequency, Urgency incontinence, Stress incontinence, Drops, Emptying difficulty, Pain /discomfort each domain raw score from 0-3 (0=not at all, 1= a little bit, 2=moderately, 3=greatly) (total raw score 18 point ) define score total 100 point if at least 16.7% means urinary incontinence and below 16.7% means nornal ( continence= no UI )

次要结局

  • Quality of life at third trimester both group(GA 36-38 wk)
  • Correlation between urinary incontinence and quality of life(GA 36-38 wk)
  • Duration of second stage of labor in both group(date of delivery)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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