Pelvic Floor Muscle WeaknessNCT03506204
The Pelvic Floor Muscle Function in Chinese Primipara, a One-year Cohort Study
An observational study of Pelvic Floor Muscle Weakness and Postpartum, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pelvic Floor Muscle Weakness, Postpartum, Primiparity
- How many people
- 3,120 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2018to 31 Dec 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
- A history of pelvic floor surgery in the previous years
Trial locations and contacts
1 site in 1 country.
Lan Zhu, MD contact
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Beijing, Beiing, 100730
Zhijing Sun, MD, 13651314354, sunzhj2001@sina.com
About this 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.
Read the 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).
- Conditions
- Pelvic Floor Muscle Weakness, Postpartum, Primiparity
- Keywords
- Pelvic floor muscle strength, Pelvic floor dysfunction, Postpartum, primipara
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum vaginal contraction pressure
it is measured by manometry, range(80-150cmH2O). The higher values represent better outcomes.
Measured: Change from Baseline Maximum Vaginal Contraction Pressure in a year after delivery
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: change from baseline in a year after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start10 May 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor Muscle WeaknessStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,120 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Liuzhou Maternity and Child Healthcare Hospital, Maternity and Child Health Hospital of Dali, Zhongshan People's Hospital, Guangdong, China, The First Affiliated Hospital with Nanjing Medical University, Second Affiliated Hospital of Soochow University, Maternity and Child Health Hospital of Changsha, Henan Provincial People's Hospital, Huaian Maternal and Child Health Care Hospital, Hunan Provincial Maternal and Child Health Care Hospital, The Fourth Hospital of Shijiazhuang, Shenzhen Luohu District Maternity And Child Healthcare Hospital, Second Affiliated Hospital of Wenzhou Medical University, Hubei Shiyan People's Hospital, Changzhi Maternity & Child Health Hospital, Maternal and Child Health Care Hospital of Xinjiang Uygur Autonomous Region, The First Hospital of Hebei Medical University, Shen-Zhen City Maternity and Child Healthcare Hospital, Dalian Medical University, Maternity and Child Care Center of QinHuangDao City, Chengdu Women's and Children's Central Hospital, Beijing Children's Hospital, Shandong Provincial Maternal and Child Health Care Hospital, The People's Hospital of Leshan, Maternal and Child Health Hospital of Hubei Province
- Responsible party
- Sponsor
- Investigators
- Lan Zhu, MD, Principal investigator, Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506204
- Sponsor's protocol ID
- JS-1549
- Status last verified
- Apr 2018
- First submitted
- 13 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pelvic Floor Muscle Function in Chinese Primipara, a One-year Cohort Study
- ClinicalTrials.gov ID
- NCT03506204
- Acronym / sponsor ID
- JS-1549
- Conditions
- Pelvic Floor Muscle Weakness, Postpartum, Primiparity
- Keywords
- Pelvic floor muscle strength, Pelvic floor dysfunction, Postpartum, primipara
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,120 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Liuzhou Maternity and Child Healthcare Hospital, Maternity and Child Health Hospital of Dali, Zhongshan People's Hospital, Guangdong, China, The First Affiliated Hospital with Nanjing Medical University, Second Affiliated Hospital of Soochow University, Maternity and Child Health Hospital of Changsha, Henan Provincial People's Hospital, Huaian Maternal and Child Health Care Hospital, Hunan Provincial Maternal and Child Health Care Hospital, The Fourth Hospital of Shijiazhuang, Shenzhen Luohu District Maternity And Child Healthcare Hospital, Second Affiliated Hospital of Wenzhou Medical University, Hubei Shiyan People's Hospital, Changzhi Maternity & Child Health Hospital, Maternal and Child Health Care Hospital of Xinjiang Uygur Autonomous Region, The First Hospital of Hebei Medical University, Shen-Zhen City Maternity and Child Healthcare Hospital, Dalian Medical University, Maternity and Child Care Center of QinHuangDao City, Chengdu Women's and Children's Central Hospital, Beijing Children's Hospital, Shandong Provincial Maternal and Child Health Care Hospital, The People's Hospital of Leshan, Maternal and Child Health Hospital of Hubei Province
- Study start
- 10 May 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 24 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maximum vaginal contraction pressure
Time frame: 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.
7 secondary outcomes
Pelvic floor muscle strength
Time frame: change from baseline in a year after delivery
Pelvic floor muscle strength（repetition）
Time frame: change from baseline in a year after delivery
Pelvic floor muscle contraction edurance
Time frame: change from baseline in a year after delivery
the knack test
Time frame: change from baseline in a year after delivery
vaginal rest pressure
Time frame: change from baseline in a year after delivery
Condition of stress urinary incontinence
Time frame: change from baseline in a year after delivery
pelvic organ prolapse quantification(POP-Q)
Time frame: change from baseline in a year after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lan Zhu, MD contact
Lan Zhu, MD principal investigator
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Muscle Weakness and Postpartum, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhijing Sun, MD (13651314354, sunzhj2001@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum vaginal contraction pressure (time frame: Change from Baseline Maximum Vaginal Contraction Pressure in a year after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018; AzTrials last refreshed its copy on 31 Oct 2026.