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

Peking Union Medical College Hospital3,120 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

3,120

Conditions

Pelvic Floor Muscle Weakness Postpartum Primiparity

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

Beijing, Beiing, China

RECRUITING

Outcomes

Primary Outcomes

Maximum vaginal contraction pressure

it is measured by manometry, range(80-150cmH2O). The higher values represent better outcomes.

Time frame: Change from Baseline Maximum Vaginal Contraction Pressure in a year after delivery

Secondary Outcomes

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.