The Pelvic Floor Muscle Function in Chinese Primipara, a One-year Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 3,120
- 试验地点
- 1
- 主要终点
- Maximum vaginal contraction pressure
研究概览
简要总结
It is a prospective cohort study.The primiparas in six geographic regions of China are recruited to observe the natural recovery of pelvic floor muscle. The pelvic floor muscle function is evaluated at 6 weeks,3 months and 12 months after delivery.
详细描述
The primiparas in six geographic regions of China are recruited to observe the natural recovery of pelvic floor muscle.Evaluation of pelvic floor function is performed at 6 weeks, 3 months, 12 months after delivery. The modified Oxford Grading Scale and Levator ani testing are used to quantify PFM strength through vaginal palpation. Pelvic floor muscles strength, endurance, repetition,vaginal contraction pressure and the knack test are evaluated using a neuromuscular stimulation therapy system of PHENIX (Company: Vivaltis -Electronic Concept Lignon Innovation, Montpellier, France).
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who give birth for the first time （Including vaginal delivery and cesarean section）
- •Term birth（37-42 weeks）
- •Single birth
- •Aged from 18 to 50
- •Plan to live locally for extended periods of time
排除标准
- •A history of incontinence before pregnancy
- •A history of fecal incontinence before pregnancy
- •Pelvic organ prolapse before pregnancy （prolapse out of the hymen ）
- •A history of abortion or induced labour over 16 weeks of pregnancy
- •Multiple pregnancy
- •The weight of the newborn is less than 2500g or more than 4000g
- •Precipitate labour
- •Operative vaginal delivery（obstetric forceps or vacuum extraction）
- •Laceration of perineum at least level III
- •Request for pelvic floor rehabilitation exercise（patients who have entered the group can not train the pelvic floor muscle）
- •Obesity （BMI before pregnancy over 25, BMI=weight (kg) / height square (m2) ）
- •Long-term abdominal pressure（chronic cough for more than 1 months ，long-term constipation ect.）
- •Cotugno's disease
- •A history of pelvic floor surgery in the previous years
结局指标
主要结局
Maximum vaginal contraction pressure
时间窗: Change from Baseline Maximum Vaginal Contraction Pressure in a year after delivery
it is measured by manometry, range(80-150cmH2O). The higher values represent better outcomes.
次要结局
- Pelvic floor muscle strength(change from baseline in a year after delivery)
- Pelvic floor muscle contraction edurance(change from baseline in a year after delivery)
- pelvic organ prolapse quantification(POP-Q)(change from baseline in a year after delivery)
- Pelvic floor muscle strength（repetition）(change from baseline in a year after delivery)
- the knack test(change from baseline in a year after delivery)
- vaginal rest pressure(change from baseline in a year after delivery)
- Condition of stress urinary incontinence(change from baseline in a year after delivery)