Pelvic Floor Muscle Weakness, Postpartum, Primiparity
Conditions
Keywords
Pelvic floor muscle strength, Pelvic floor dysfunction, Postpartum, primipara
Brief summary
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
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).
Interventions
None listed
Sponsors
Liuzhou Maternity and Child Healthcare Hospital
Maternity and Child Health Hospital of Dali
Zhongshan People's Hospital, Guangdong, China
The First Affiliated Hospital with Nanjing Medical University
Second Affiliated Hospital of Soochow University
Maternity and Child Health Hospital of Changsha
Henan Provincial People's Hospital
Huaian Maternal and Child Health Care Hospital
Hunan Provincial Maternal and Child Health Care Hospital
The Fourth Hospital of Shijiazhuang
Shenzhen Luohu District Maternity And Child Healthcare Hospital
Second Affiliated Hospital of Wenzhou Medical University
Hubei Shiyan People's Hospital
Changzhi Maternity & Child Health Hospital
Maternal and Child Health Care Hospital of Xinjiang Uygur Autonomous Region
The First Hospital of Hebei Medical University
Shen-Zhen City Maternity and Child Healthcare Hospital
Dalian Medical University
Maternity and Child Care Center of QinHuangDao City
Chengdu Women's and Children's Central Hospital
Shunyi Maternal and Children's Hospital of Beijing Children's Hospital
Shandong Provincial Maternal and Child Health Care Hospital
The People's Hospital of Leshan
Hubei Maternal and Child Health Hospital
Peking Union Medical College Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Women who give birth for the first time （Including vaginal delivery and cesarean section） 2. Term birth（37-42 weeks） 3. Single birth 4. Aged from 18 to 50 5. Plan to live locally for extended periods of time
Exclusion criteria
1. A history of incontinence before pregnancy 2. A history of fecal incontinence before pregnancy 3. Pelvic organ prolapse before pregnancy （prolapse out of the hymen ） 4. A history of abortion or induced labour over 16 weeks of pregnancy 5. Multiple pregnancy 6. The weight of the newborn is less than 2500g or more than 4000g 7. Precipitate labour 8. Operative vaginal delivery（obstetric forceps or vacuum extraction） 9. Laceration of perineum at least level III 10. Request for pelvic floor rehabilitation exercise（patients who have entered the group can not train the pelvic floor muscle） 11. Obesity （BMI before pregnancy over 25, BMI=weight (kg) / height square (m2) ） 12. Asthma 13. Long-term abdominal pressure（chronic cough for more than 1 months ，long-term constipation ect.） 14. Diabetes 15. Cotugno's disease 16. A history of pelvic floor surgery in the previous years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum vaginal contraction pressure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic floor muscle strength（repetition） | change from baseline in a year after delivery | Levator ani testing is used to quantify PFM strength.range(0-5).The higher values represent better outcomes. |
| Pelvic floor muscle contraction edurance | change from baseline in a year after delivery | 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. |
| the knack test | change from baseline in a year after delivery | a voluntary PFM contraction before or during coughing.That the contraction could be performed represents normal. |
| Pelvic floor muscle strength | change from baseline in a year after delivery | The modified Oxford Grading Scale is used to quantify PFM strength through vaginal palpation.range(0-5).The higher values represent better outcomes. |
| Condition of stress urinary incontinence | change from baseline in a year after delivery | Ingelman-Sundberg classification is used according to the clinical symptoms of urinary incontinence, divided into mild, moderate and severe. |
| pelvic organ prolapse quantification(POP-Q) | change from baseline in a year after delivery | POP-Q is measured when maximum valsalva.range(0-4). stage 0 represents normal. |
| vaginal rest pressure | change from baseline in a year after delivery | measure when no vaginal contraction by manometry. range(25-50 cmH2O). the lower and the higher values represent abnormal outcomes. |
Countries
China
Contacts
Primary ContactZhijing Sun, MD
Backup ContactLan Zhu, MD
Outcome results
None listed