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

NCT03506204 | Unknown

• 1 other identifier: JS-1549
• Study Type: observational
• Target: 3,120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Muscle Weakness; Postpartum; Primiparity

Keywords

Pelvic floor muscle strength; Pelvic floor dysfunction; Postpartum; primipara

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Pelvic floor muscle strength

  change from baseline in a year after delivery

• Pelvic floor muscle strength（repetition）

  change from baseline in a year after delivery

• Pelvic floor muscle contraction edurance

  change from baseline in a year after delivery

• the knack test

  change from baseline in a year after delivery

• vaginal rest pressure

  change from baseline in a year after delivery

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Women who give birth for the first time （Including vaginal delivery and cesarean section）
• Term birth（37-42 weeks）
• Single birth
• Aged from 18 to 50
• Plan to live locally for extended periods of time

You may not qualify if:

• A history of incontinence before pregnancy
• A history of fecal incontinence before pregnancy
• Pelvic organ prolapse before pregnancy （prolapse out of the hymen ）
• A history of abortion or induced labour over 16 weeks of pregnancy
• Multiple pregnancy
• The weight of the newborn is less than 2500g or more than 4000g
• Precipitate labour
• Operative vaginal delivery（obstetric forceps or vacuum extraction）
• Laceration of perineum at least level III
• Request for pelvic floor rehabilitation exercise（patients who have entered the group can not train the pelvic floor muscle）
• Obesity （BMI before pregnancy over 25, BMI=weight (kg) / height square (m2) ）
• Asthma
• Long-term abdominal pressure（chronic cough for more than 1 months ，long-term constipation ect.）
• Diabetes
• Cotugno's disease

Sponsors & Collaborators

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

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

Beijing, Beiing, 100730, China

RECRUITING

Study Officials

• Lan Zhu, MD

  Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhijing Sun, MD

CONTACT

13651314354; sunzhj2001@sina.com

Lan Zhu, MD

CONTACT

zhu_julie@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: April 24, 2018
• Study Start: May 10, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 11, 2018

Record last verified: 2018-04

Locations

CN (1)