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临床试验/NCT05004402
NCT05004402已完成不适用

Pelvic Floor Muscle Function, Pelvic Floor Dysfunction and Diastasis Recti Abdominis in Postpartum Women

Żelazna Medical Centre, LLC2 个研究点 分布在 1 个国家目标入组 345 人开始时间: 2021年8月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
345
试验地点
2
主要终点
Palpation examination of pelvic floor muscles with the use of PERFECT Scheme

研究概览

简要总结

Background: Pregnancy and childbirth are factors that affect a woman's pelvic floor. Pelvic floor disorders (PFD) often occur in the perinatal period. Symptoms and difficulties related to urinary continence and/or pelvic organ prolapse significantly affect daily activities, including physical activity, but also the quality of life and sexual activity. Patient education that includes both the anatomy and function of the pelvic floor, as well as information on the prevention of PFD during pregnancy and postpartum is an important part of the prevention of these dysfunctions. Diastasis recti abdominis (DRA) is another common musculoskeletal issue related to pregnancy and postpartum period. In addition to the cosmetic consequences, it can be associated with abdominal pain, the occurrence of pelvic floor dysfunction and a negative correlation with the image of a woman's own body.

Material and Methods: Primiparous women after vaginal delivery will be invited to this study. The study will consist of three stages. First phase (baseline measurements) will take place at the hospital and the following assessments will be performed: pelvic floor muscle palpation examination (PERFECT scheme, OXFORD scale, Reissing scale), palpation and ultrasound examination of diastasis recti abdominis. After 12-16 weeks postpartum participants will complete questionnaires about pelvic floor dysfunctions and diastasis recti and their impact on quality of life. Third part, 12-16 weeks postpartum, the pelvic floor muscle examination, palpation and ultrasound examination of diastasis recti abdominis will be repeated.

Objectives: The aim of this study is to assess the function of the pelvic floor muscles, prevalence of pelvic floor dysfunctions and diastasis recti abdominis in the primiparous women postpartum. Our secondary objective will be investigation if there are any prognostics factors during the early postpartum period, that can indicate higher risk of PFD and/or DRA 3 months postpartum.

Expected results: Results of this study will inform about prevalence of pelvic floor dysfunctions and diastasis recti in primiparous women in Poland. Additionally, we hope to obtain predictors suggesting pelvic floor or abdominal muscles dysfunction 3 months postpartum. Prevention of pelvic floor disorders may contribute to the early identification of problems and reduce cost of treatment of unrecognized dysfunction. To our knowledge this will be the first study in this area conducted in Poland.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Vaginal delivery between 38-42 weeks of pregnancy
  • First delivery
  • Agreement to participate
  • Good command of spoken and written Polish

排除标准

  • Contraindications for the examination of the pelvic floor muscles (postpartum hematoma of the perineum, extensive perineal swelling, perineal wound dehiscence, bladder catheterization).
  • Lack of consent to participate in the study
  • Lack of good command of spoken and written Polish

研究组 & 干预措施

Primiparous women

Primiparous women after vaginal delivery

结局指标

主要结局

Palpation examination of pelvic floor muscles with the use of PERFECT Scheme

时间窗: 12-16 weeks postpartum

Assesment of pelvic floor muscles with the use of PERFECT Scheme.

Ultrasound measurement of inter-recti distance (IRD)

时间窗: 12-16 weeks postpartum

Measurement of inter-recti distance (IRD) using the ultrasound.

Polish version of the Pelvic Floor Distress Inventory (PFDI-20)

时间窗: 12-16 weeks postpartum

Condition-specific questionnaire will be used to assess how pelvic floor disorders affect quality of life. It consist of 3 scales, 20 questions. Every scale is scored from 0- no distress to 100 - the greatest distress. The scores from 3 scales are summarized to achieve summary score (0-300).

Polish Version of the Female Sexual Function Index (FSFI)

时间窗: 12-16 weeks postpartum

Assessment of sexual function in women, in 6 domains (desire, arousal, lubrication, orgasm, satisfaction, pain) scored 0-6. The summarized maximum score is 36. Results ≤27,50 indicate risk for sexual dysfunction.

Polish version of the Pelvic Floor Impact Questionnaire short form 7 (PFIQ-7)

时间窗: 12-16 weeks postpartum

Condition-specific questionnaire, will be used to assess impact of pelvic floor disorders on quality of life (daily activities, relationships and emotions). It consists of 3 scales which are scored 0-100. The results from 3 scales are summarized to achieve the summary score (0-300). Higher numbers indicate greater impact.

Palpation examination of pelvic floor muscles with the use of PERFECT Scheme

时间窗: 24-72 hours postpartum

Assesment of pelvic floor muscles with the use of PERFECT Scheme.

Ultrasound measurement of inter-recti distance (IRD)

时间窗: 24-72 hours postpartum

Measurement of inter-recti distance (IRD) using the ultrasound.

次要结局

  • Palpation evaluation of pelvic muscle tone with Reissing scale(12-16 weeks postpartum)
  • Palpable measurement of inter-recti distance (IRD)(12-16 weeks postpartum)
  • Palpation evaluation of pelvic muscle tone with Reissing scale(24-72 hours postpartum)
  • Palpable measurement of inter-recti distance (IRD)(24-72 hours postpartum)

研究者

发起方
Żelazna Medical Centre, LLC
申办方类型
Other
责任方
Sponsor

研究点 (2)

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