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临床试验/NCT03349736
NCT03349736已完成不适用

Pelvic Floor Muscle Training Programme in Pregnant Nepalese Women- a Feasibility Study

Kathmandu University School of Medical Sciences2 个研究点 分布在 1 个国家目标入组 253 人开始时间: 2017年6月25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
253
试验地点
2
主要终点
To develop a PFMT programme and and second to assess the feasibility in terms of recruitment capability, sample characteristics, data collection procedures, outcome measures, and acceptability of the PFMT programme in pregnant Nepalese women.

研究概览

简要总结

To our knowledge, no studies in Nepal have reported the feasibility of performing the pelvic floor muscle training in Nepalese women. The aim of the study is to develop and a pelvic floor muscle training programme based on information, education (leaflet, video) and pelvic floor muscles (PFM) exercise in order to prevent or reduce Pelvic organ prolapse(POP) and Urinary Incontinence (UI) in pregnant Nepalese women.

The women will receive information (leaflet, video, posters) and guidance on PFMT. Following this, the women are advised to perform daily home PFM exercise Women will record their home PFMT using an exercise diary.

详细描述

PFM supports the bowel, bladder, and uterus. Pelvic floor dysfunction can lead to gynecological problems like POP and UI. POP is the downward displacement of uterus from its normal anatomical position and UI is the involuntary leakage of urine.

In Nepal, the prevalence of POP is 10% in women of reproductive age and reported UI is 60% and 50.6% from two studies. POP risk factors include early marriage, high parity, squatting during delivery, prolonged labor, increasing age, menopause, hysterectomy, smoking, obesity, heavy lifting, and early return to work after parturition. High reports of POP and UI could be due to the exposure to these potential risks factors in Nepalese women. Women in Nepal play a significant role in agricultural and household work and are exposed to these risks factors daily. Studies have shown that besides longer days with work, women have less time for sleep and leisure. One of the main work-related health problems for Nepalese women is the physical effect of chronic overwork due to women's triple roles and subordinate position in the family.

The government of Nepal created a fund to provide free surgery to women with POP in 2008. Surgery is a common treatment for POP, however, 58% report an occurrence of recurrent prolapse after surgery and 29% report re-operations. PFM exercise has Level I evidence for treatment (Stage 1 & 2) or prevention of POP. Women diagnosed with POP in Nepal, have 69.1% first-degree prolapse while the remaining 30.9% suffer from second and third-degree prolapse. Women's reluctance to seek treatment might be lack of family support, high costs for travel, food and lodging and ineffective treatment. Moreover, the health facilities are poor in rural areas as the infrastructure is weak, with few roads and commonly in poor condition which makes it more difficult. The PFM exercise does not need an instrument and can be done at home/workplace. PFM exercise for the treatment of POP (stage 1 & 2) and UI was popularized by Kegel exercise. The use of PFM exercise is based on two functions of the PFM, support of the pelvic organs and a contribution to the sphincter closure mechanism of the urethra.

This project will investigate the feasibility of a cost-effective physiotherapy program based on information, education, and PFMT, hopefully, to help improve the health outcome of Nepalese women. The feasibility study will be essential for a future cluster randomized controlled study.

Hence, the aim is to assess the feasibility of performing PFMT in pregnant women to help prevent or reduce POP and UI in Nepal.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • pregnant women able to understand information and instructions in the Nepalese language

排除标准

  • women with psychiatric diagnosis
  • pregnancy related complications like pre-eclampsia
  • risk of threatened abortion
  • more than 16 weeks duration in 1st visit and
  • not willing to participate or not able to communicate

结局指标

主要结局

To develop a PFMT programme and and second to assess the feasibility in terms of recruitment capability, sample characteristics, data collection procedures, outcome measures, and acceptability of the PFMT programme in pregnant Nepalese women.

时间窗: 21 weeks

Acceptability of the PFMT programme was assessed by attendance at supervised PFMT hospital visits, adherence to daily PFMT, and participant experiences of attending the programme.

次要结局

未报告次要终点

研究者

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

Ranjeeta Shijagurumayum Acharya

Physiotherapists,PT,MSc

Kathmandu University School of Medical Sciences

研究点 (2)

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