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NCT03921463 Clinical Trial

Changes of Pelvic Floor Functions in Women at Different Postpartum Time

Pelvic Floor Disorders Clinical Trial

Official title:
the Key Laboratory of Female Pelvic Floor Disorders Diseases, Beijing, China

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03921463
Other study ID # PKUPH4
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2019
Est. completion date April 2020

Study information
Verified date April 2019
Source Peking University People's Hospital
Contact Qing Wang
Phone 18811179067
Email 2283544885@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 130
Est. completion date April 2020
Est. primary completion date April 2020
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 35 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China The Peking University People's Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of pelvic floor muscle strength abnormality at different postpartum time 6 month
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