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临床试验/NCT06502392
NCT06502392招募中不适用

Correlation Between Creatine Phosphokinase and Pelvic Floor Muscle Strength in Postnatal Women

Cairo University1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
84
试验地点
1
主要终点
Assessment of creatine phosphokinase

研究概览

简要总结

The purpose of this study is to determine the correlation between creatine phosphokinase and pelvic floor muscle strength in post-partum women.

详细描述

Pelvic floor disorders (PFDs) are complex conditions affecting women's quality of life, including issues like pelvic organ prolapse, urinary incontinence, and pelvic pain. These disorders are prevalent, with 2.6-28.7% of women experiencing urinary incontinence and 20-50% suffering from pelvic organ prolapse. Accurate diagnosis requires a comprehensive understanding of pelvic musculoskeletal components and the interaction of multiple body systems.

Creatine phosphokinase (CPK) activity can be elevated in various conditions, including muscle diseases, burns, and after strenuous exercise. During childbirth, increased serum CPK levels have been observed, attributed to enzyme release from the uterus and placenta. CPK levels typically return to normal within six weeks postpartum.

To date, no study has explored the correlation between CPK levels and pelvic floor muscle strength in postnatal women. This research aims to fill this knowledge gap, potentially benefiting medical services and expanding understanding in women's health physical therapy.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • Post-partum women who delivered vaginally.
  • Their ages will range from 25 to 35 years old.
  • Their body mass index (BMI) will be <30 Kg/m
  • CPK will be measured within the first six weeks (2nd-5th weeks) after delivery for all women.

排除标准

  • Any dysfunction or associated injury or any pathological conditions which may affect the result of the study as cardiac abnormalities, thyroid dysfunction recurrent urinary tract infections, uncontrolled hypertension or diabetes mellitus.
  • History of pelvic inflammatory disease, myoma and tumors, pelvic infection, ovarian cyst, any gynecological disease, any hormonal abnormality and any psychological problem.
  • Pelvic floor dysfunction: genital prolapse, incontinence.
  • Previous surgical operations as hysterectomy.
  • Inability to understand the written and verbal instructions.

结局指标

主要结局

Assessment of creatine phosphokinase

时间窗: It will be measured within the first six weeks after delivery (2nd-5th weeks).

It will be assessed through collecting a blood sample. The collected blood will be transferred into a sterile vacutainer tubes (9 mL) with anticoagulant and will be placed symmetrically into the centrifuge device. The serum will be separated from blood and will be put in epindoorf tubes and send immediately for analysis. Serum CPK will be quantitatively measured in units/liter (u/l) on a Vitros 950 automated analyzer shortly after the receipt of the specimen.

Assessment of pelvic floor muscle endurance

时间窗: It will be measured within the first six weeks after delivery (2nd-5th weeks).

It will be assessed by a biofeedback. Women will be positioned comfortably for pelvic floor muscle endurance assessment using a TG Myo feedback 420v vaginal electrode. The electrode will be properly prepared and inserted. The therapist will explain the display and will establish a one-minute baseline, noting any inconsistencies. Women will perform three 10-second maximum contractions. Muscle endurance will be measured as the time a sub-maximum contraction can be maintained before significant power reduction occurs.

Assessment of pelvic floor muscle strength

时间窗: It will be measured within the first six weeks after delivery (2nd-5th weeks).

It will be assessed by a biofeedback. Women will be positioned comfortably for pelvic floor muscle (PFM) strength assessment using a TG Myo feedback 420v vaginal electrode. The electrode, properly prepared and inserted, will measure vaginal closure pressure and deep PFM strength. The therapist will explain the display and will establish a one-minute baseline, noting any inconsistencies. Women will perform three 10-second maximum contractions, with the mean of these readings to be recorded. Muscle strength will be measured by peak maximum pressure and ability to sustain contraction.

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

Hadeer mostafa

Principal Investigator

Cairo University

研究点 (1)

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