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

May 10, 2018 updated by: Peking Union Medical College Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline Maximum Vaginal Contraction Pressure in a year after delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pelvic floor muscle strength
Time Frame: change from baseline in a year after delivery
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）
Time Frame: change from baseline in a year after delivery
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
Time Frame: change from baseline in a year after delivery
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
Time Frame: change from baseline in a year after delivery
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
Time Frame: change from baseline in a year after delivery
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
Time Frame: change from baseline in a year after delivery
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)
Time Frame: change from baseline in a year after delivery
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pelvic Floor Muscle Weakness

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings