Changes of Pelvic Floor Functions in Women at Different Postpartum Time

• Conditions: Pelvic Floor Disorders

• Registration Number: NCT03921463
• Lead Sponsor: Peking University People's Hospital

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 available

Study Timeline

• Status Verified: 2019-04
• Study Start: 2019-04
• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-04-17
• Last Update Submitted: 2019-04-17
• Study First Posted: 2019-04-19
• Last Update Posted: 2019-04-19
• Primary Completion: 2020-04
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 130

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of pelvic floor muscle strength abnormality at different postpartum time	6 month

Trial Locations

Locations (1)

The Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China