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

• Conditions: Postpartum; Primiparity; Pelvic Floor Muscle Weakness

• Registration Number: NCT03506204
• Lead Sponsor: Peking Union Medical College Hospital

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).

Study Timeline

• Status Verified: 2018-04
• Study First Submitted: 2018-04-13
• Study First Submitted QC: 2018-04-23
• Study First Posted: 2018-04-24
• Study Start: 2018-05-10
• Last Update Submitted: 2018-05-10
• Last Update Posted: 2018-05-11
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 3120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences; 🇨🇳 Beijing, Beiing, China