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

Postpartum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03506204
• Other study ID #: JS-1549
• Status: Recruiting
• Start date: May 10, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2018
• Source: Peking Union Medical College Hospital
• Contact: Zhijing Sun, MD
• Phone: 13651314354
• Email: sunzhj2001[@]sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3120
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis
• Pelvic Floor Muscle Weakness
• Postpartum
• Primiparity

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences	Beijing	Beiing

Sponsors (26)

Lead Sponsor

Collaborator

Peking Union Medical College Hospital

Changzhi Maternity & Child Health Hospital, Chengdu Women's and Children's Central Hospital, Dalian Gynaecology and Obstetrics Hospital, Dalian Municipal Women and Children's Medical Center, Fourth Hospital of Shijiazhuang City, Henan Provincial Hospital, Huaian Maternal and Child Health Care Hospital, Hubei Maternal and Child Health Hospital, Hubei Shiyan People's Hospital, Hunan Provincial Maternal and Child Health Care Hospital, Liuzhou Maternity and Child Healthcare Hospital, Maternal and Child Health Care Hospital of Xinjiang Uygur Autonomous Region, Maternity and Child Care Center of QinHuangDao City, Maternity and Child Health Hospital of Changsha, Maternity and Child Health Hospital of Dali, Second Affiliated Hospital of Soochow University, Second Affiliated Hospital of Wenzhou Medical University, Shandong Provincial Maternal and Child Health Care Hospital, Shen-Zhen City Maternity and Child Healthcare Hospital, Shenzhen Luohu District Maternity And Child Healthcare Hospital, Shunyi Maternal and Children's Hospital of Beijing Children's Hospital, The First Affiliated Hospital with Nanjing Medical University, The First Hospital of Hebei Medical University, The People's Hospital of Leshan, Zhongshan City People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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