The Pelvic Floor Muscle Function in Chinese Primipara, a One-year Cohort Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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The Pelvic Floor Muscle Function in Chinese Primipara, a One-year Cohort Study

Conditions
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Pelvic Floor Muscle Weakness, Postpartum, Primiparity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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) ） Asthma Long-term abdominal pressure（chronic cough for more than 1 months ，long-term constipation ect.） Diabetes Cotugno's disease A history of pelvic floor surgery in the previous years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum vaginal contraction pressure | it is measured by manometry, range(80-150cmH2O). The higher values represent better outcomes. | Change from Baseline Maximum Vaginal Contraction Pressure in a year after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic floor muscle strength | The modified Oxford Grading Scale is used to quantify PFM strength through vaginal palpation.range(0-5).The higher values represent better outcomes. | change from baseline in a year after delivery | 
| Pelvic floor muscle strength（repetition） | Levator ani testing is used to quantify PFM strength.range(0-5).The higher values represent better outcomes. | change from baseline in a year after delivery | 
| Pelvic floor muscle contraction edurance | muscle contractions maintained for 0 s are defined as grade 0, 1 s as grade I, 2 s as grade II, 3 s as grade III, 4 s as grade IV, and 5 s or longer as grade V. Normal muscles can maintain the contraction for 5 s.range(0-5s).The higher values represent better outcomes. | change from baseline in a year after delivery | 
| the knack test | a voluntary PFM contraction before or during coughing.That the contraction could be performed represents normal. | change from baseline in a year after delivery | 
| vaginal rest pressure | measure when no vaginal contraction by manometry. range(25-50 cmH2O). the lower and the higher values represent abnormal outcomes. | change from baseline in a year after delivery | 
| Condition of stress urinary incontinence | Ingelman-Sundberg classification is used according to the clinical symptoms of urinary incontinence, divided into mild, moderate and severe. | change from baseline in a year after delivery | 
| pelvic organ prolapse quantification(POP-Q) | POP-Q is measured when maximum valsalva.range(0-4). stage 0 represents normal. | change from baseline in a year after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic floor muscle strength, Pelvic floor dysfunction, Postpartum, primipara