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临床试验/NCT04757077
NCT04757077已完成不适用

The Association Between Pelvic Floor Muscle Function, Diastasis Recti and Postpartum Pelvic Girdle Pain - a Matched Case Control Study.

Żelazna Medical Centre, LLC1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2021年2月22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
56
试验地点
1
主要终点
Perineometry of the pelvic floor - vaginal resting pressure.

研究概览

简要总结

Background: Pregnancy-related pelvic girdle pain (PGP) can appear during pregnancy, directly after labour or can be delayed to 3 weeks postpartum. Pain is experienced between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the sacroiliac joint (SIJ). The pain may radiate in the posterior thigh and can also occur in conjunction with/or separately in the symphysis. The endurance capacity for standing, walking, and sitting is diminished. The diagnosis of PGP can be reached after exclusion of lumbar causes. The pain or functional disturbances in relation to PGP must be reproducible by specific clinical tests. Lack of accurate and early diagnosis of the PGP postpartum may contribute to development of chronic condition, lowering quality of life years after delivery. There is uncertainty regarding the association between the function of the pelvic floor muscles (PFM), diastasis recti and postpartum pelvic girdle pain (PGP). Although widely researched abroad, there is a paucity in research about biopsychosocial profile of women with postpartum PGP in Poland.

Objectives: The aim of this one-to-one matched case-control study it to examine whether there is any difference in PFM function and diastasis recti between women with and without clinically diagnosed PGP. Additionally, differences in biopsychosocial profile (depression, anxiety, stress, catastrophizing and kinesiophobia) will be assessed.

Materials and methods: Because of low incidence of researched condition, a case control study will be the study design of choice. Women 6-24 weeks after delivery with postpartum PGP will be matched with those with no PGP. Subjects' assessment will consist of palpation examination of diastasis recti (inter-recti distance) and pelvic floor muscles. Perineometry of the pelvic floor will also be conducted. Additionally, several questionnaires for the assessment of mental processing will be used: Depression Anxiety Stress Scale 21, Pain Catastrophizing Scale and Tampa Scale of Kinesiophobia. Participants will be matched according to age, parity and time postpartum.

Expected results: To our knowledge, postpartum pelvic girdle pain has not been extensively studied in Poland so far. The study will bring information about the possible associations with postpartum PGP. We hypothesize that the study will confirm our clinical observations about pelvic floor dysfunction and maladaptive mental processing in women with postpartum PGP.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

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 labour (including vacuum extractor or forceps) or caesarean section
  • For group with PGP: pain due to PGP
  • For control group with no pain - no pain due to PGP
  • Agreement to participate

排除标准

  • Diseases that can mimic PGP f.ex. Scheuermann disease, rheumatoid arthritis, Ehler's-Danlos Syndrome, hip dysplasia.

结局指标

主要结局

Perineometry of the pelvic floor - vaginal resting pressure.

时间窗: one time assessment, 6-24 weeks after delivery

Measurement of the vaginal resting pressure.

Palpable measurement of inter-recti distance (IRD)

时间窗: one time assessment, 6-24 weeks after delivery

Palpable measurement of inter-recti distance (IRD)

Perineometry of the pelvic floor - vaginal squeeze pressure.

时间窗: one time assessment, 6-24 weeks after delivery

Measurement of the vaginal squeeze pressure.

次要结局

  • Perineometry of the pelvic floor - endurance(one time assessment, 6-24 weeks after delivery)
  • Palpation examination of pelvic floor muscles with the use of PERFECT Scheme(one time assessment, 6-24 weeks after delivery)
  • Depression Anxiety Stress Scale 21(one time assessment, 6-24 weeks after delivery)
  • Diastasis Recti: palpation examination of the stability of the linea alba(one time assessment, 6-24 weeks after delivery)
  • Pain Catastrophizing Scale(one time assessment, 6-24 weeks after delivery)

研究者

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

研究点 (1)

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