Clinical trial NCT03506204: The Pelvic Floor Muscle Function in Chinese Primipara, a One-year Cohort Study
Official title: The Pelvic Floor Muscle Function in Chinese Primipara, a One-year Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Floor Muscle Weakness
Postpartum
Primiparity
Keywords: Pelvic floor muscle strength
Pelvic floor dysfunction
Postpartum
primipara
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Liuzhou Maternity and Child Healthcare Hospital
name: Maternity and Child Health Hospital of Dali
name: Zhongshan People's Hospital, Guangdong, China
name: The First Affiliated Hospital with Nanjing Medical University
name: Second Affiliated Hospital of Soochow University
name: Maternity and Child Health Hospital of Changsha
name: Henan Provincial People's Hospital
name: Huaian Maternal and Child Health Care Hospital
name: Hunan Provincial Maternal and Child Health Care Hospital
name: Fourth Hospital of Shijiazhuang City
name: Shenzhen Luohu District Maternity And Child Healthcare Hospital
name: Second Affiliated Hospital of Wenzhou Medical University
name: Hubei Shiyan People's Hospital
name: Changzhi Maternity & Child Health Hospital
name: Maternal and Child Health Care Hospital of Xinjiang Uygur Autonomous Region
name: The First Hospital of Hebei Medical University
name: Shen-Zhen City Maternity and Child Healthcare Hospital
name: Dalian Medical University
name: Maternity and Child Care Center of QinHuangDao City
name: Chengdu Women's and Children's Central Hospital
name: Shunyi Maternal and Children's Hospital of Beijing Children's Hospital
name: Shandong Provincial Maternal and Child Health Care Hospital
name: The People's Hospital of Leshan
name: Hubei Maternal and Child Health Hospital
First posted: 2018-04-24
Enrollment: 3120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Maximum vaginal contraction pressure
timeFrame: Change from Baseline Maximum Vaginal Contraction Pressure in a year after delivery
Secondary outcomes:
measure: Pelvic floor muscle strength
timeFrame: change from baseline in a year after delivery
measure: Pelvic floor muscle strength（repetition）
timeFrame: change from baseline in a year after delivery
measure: Pelvic floor muscle contraction edurance
timeFrame: change from baseline in a year after delivery
measure: the knack test
timeFrame: change from baseline in a year after delivery
measure: vaginal rest pressure
timeFrame: change from baseline in a year after delivery
measure: Condition of stress urinary incontinence
timeFrame: change from baseline in a year after delivery
measure: pelvic organ prolapse quantification(POP-Q)
timeFrame: change from baseline in a year after delivery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
state: Beiing
Study officials:
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
name: Lan Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References: