Changes of Pelvic Floor Functions in Women at Different Postpartum Time

• ClinicalTrials.gov Identifier: NCT03921463
• Recruitment Status: Unknown
• First Posted: April 19, 2019
• Last Update Posted: April 19, 2019
• Sponsor: Peking University People's Hospital
• Information provided by (Responsible Party): Peking University People's Hospital

Tracking Information

• First Submitted Date: April 17, 2019
• First Posted Date: April 19, 2019
• Last Update Posted Date: April 19, 2019
• Estimated Study Start Date: April 2019
• Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 17, 2019): Incidence of pelvic floor muscle strength abnormality at different postpartum time [ Time Frame: 6 month ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Changes of Pelvic Floor Functions in Women at Different Postpartum Time
• Official Title: the Key Laboratory of Female Pelvic Floor Disorders Diseases, Beijing, China
• Brief Summary: The main purpose of this study was to observe the pelvic floor muscle strength abnormalities of cesarean section and vaginal delivery at different time points within six months after delivery without any intervention. It was a prospective observational study, and the main study population was healthy postpartum women. Regular follow-up was conducted at 6 weeks, 9 weeks, 3 months, 4 months, 5 months and 6 months postpartum. The follow-ups included gynecological examination, pelvic floor electrophysiological indexes (category I and II muscle fiber strength and fatigue), questionnaire (ICI- Q-SF, OABSS, UDI-6), and pelvic floor ultrasound. The incidence of pelvic floor muscle strength abnormality at different postpartum time points was statistically analyzed, the high-risk factors of postpartum pelvic floor function abnormality caused by pregnancy and delivery were analyzed, and the general rules of the natural development of pelvic floor function were observed.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: healthy postpartum women
• Condition: Pelvic Floor Disorders
• Intervention: Not Provided

Study Groups/Cohorts

• caesarean section
• vaginal delivery

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 17, 2019): 130
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2020
• Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 1)Age: 20 ~35 years old; 2) first parturients registered in the obstetrics department of our hospital; 3) no medical complications before pregnancy, no UI and POP (according to the standard of POP-Q stage); 4) no obstetric complications; 5) the patients agreed to conduct the study and signed the informed consent.

Exclusion Criteria:

• 1) patients with uncontrolled epilepsy, central nervous system diseases or mental disorders, whose clinical severity shall be determined by the researcher to affect clinical research compliance; 2) follow up the patients with difficulty.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 20 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03921463
• Other Study ID Numbers: PKUPH4
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: 6 month

• Responsible Party: Peking University People's Hospital
• Study Sponsor: Peking University People's Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Peking University People's Hospital
• Verification Date: April 2019