Changes of Pelvic Floor Functions in Women at Different Postpartum Time

NCT03921463 | Unknown

• 1 other identifier: PKUPH4
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (1)

• Incidence of pelvic floor muscle strength abnormality at different postpartum time

  6 month

Study Arms (2)

caesarean section

vaginal delivery

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

healthy postpartum women

You may qualify if:

• )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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

The Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Central Study Contacts

Qing Wang

CONTACT

18811179067; 2283544885@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 19, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 19, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 6 month

Locations

CN (1)