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

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.

Study Overview

• Status: Unknown
• Conditions: Pelvic Floor Muscle Weakness; Postpartum; Primiparity

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 Type: Observational
• Enrollment (Anticipated): 3120

Contacts and Locations

Study Locations

• China
  • Beiing
    • Beijing, Beiing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Six geographic regions of China are needed to be covered, and more than 1-2 hospitals in each area should be included. The primipara are recruited while having their routine follow-up 6 weeks after delivery at the outpatient department in local hospitals.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Henan Provincial People's Hospital; Second Affiliated Hospital of Wenzhou Medical University; Second Affiliated Hospital of Soochow University; The First Hospital of Hebei Medical University; Chengdu Women's and Children's Central Hospital; Fourth Hospital of Shijiazhuang City; Shen-Zhen City Maternity and Child Healthcare Hospital; Liuzhou Maternity and Child Healthcare Hospital; Maternity and Child Health Hospital of Dali; Zhongshan City People's Hospital; Maternity and Child Health Hospital of Changsha; Huaian Maternal and Child Health Care Hospital; Hunan Provincial Maternal and Child Health Care Hospital; Shenzhen Luohu District Maternity And Child Healthcare Hospital; Hubei Shiyan People's Hospital; Changzhi Maternity & Child Health Hospital; Maternal and Child Health Care Hospital of Xinjiang Uygur Autonomous Region; Dalian Medical University; Maternity and Child Care Center of QinHuangDao City; 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

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: April 13, 2018
• First Submitted That Met QC Criteria: April 23, 2018
• First Posted (Actual): April 24, 2018

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Postpartum; Pelvic floor dysfunction; primipara; Pelvic floor muscle strength
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness
• Other Study ID Numbers: JS-1549

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No