Prevalence and Risk Factors for Pelvic Floor Disorders

Pelvic Floor Disorders Clinical Trial

Official title:

Prevalence and Risk Factors for Pelvic Floor Disorders During Pregnancy in a Cohort of Egyptian Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04185376
• Other study ID #: fayoum
• Status: Completed
• Start date: December 15, 2019
• Est. completion date: December 10, 2020

Study information

• Verified date: February 2021
• Source: Fayoum University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pelvic floor disorders (PFD) can adversely affect the quality of life of a woman and they can occur during different stages of female life such as during pregnancy, early postpartum period or during menopause. It is well known that pregnancy and vaginal birth are significant risk factors in the etiology of PFD and predicting models like UR-CHOICE score were developed for this reason to provide mothers-to-be with sufficient information regarding their subsequent risk of PFD. Pregnancy, childbirth and the immediate postpartum period, where the demands on the pelvic floor and the incidence of pelvic floor trauma are particularly high, offers an optimal opportunity for such counseling and prevention.

Description:

Pelvic floor disorders (PFDs) can adversely affect the quality of life (QoL) of a woman and they can occur during different stages of female life such as during pregnancy, early postpartum period or during menopause. The reported prevalence of PFDs varies widely both during and after pregnancy and reported up to 30-50%. Besides, the term PFD includes a broad spectrum of conditions such as urinary incontinence (UI), pelvic organ prolapse (POP) or anal incontinence (AI). Many risk factors seem to be involved like the pregnancy itself, mode of delivery, parity, the use of episiotomy, obesity, increased age and so on. It is well known that pregnancy and vaginal birth are significant risk factors in the etiology of PFDs and predicting models like UR-CHOICE score were developed for this reason to provide mothers-to-be with sufficient information regarding their subsequent risk of PFD. The identification of women during their pregnancy who are at higher risk for PFD remains a key element in targeting of prevention and planning health of resource allocation strategies. Pregnancy, childbirth and the immediate postpartum period, where the demands on the pelvic floor and the incidence of pelvic floor trauma are particularly high, offers an optimal opportunity for such counseling and prevention. The validated German pelvic floor questionnaire modified for pregnancy and postpartum period is thus an important tool identifying such symptoms and helping clinicians assess patient's quality of life. The aim of the present study was to evaluate the prevalence of PFDs in a cohort of Egyptian women during pregnancy. Furthermore, we searched for clinical risk factors that correlate with the occurrence of PFDs during pregnancy in the investigator's population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 10, 2020
• Est. primary completion date: November 30, 2020
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• age over 18 years

• any trimester of pregnancy

• planned delivery at our institution.

Exclusion Criteria:

• Women with the inability to complete the questionnaire

Related Conditions & MeSH terms

• Pelvic Floor Disorders

Intervention

Other:
• Questionnaire
a self-administered questionnaire for the assessment of pelvic floor disorders, their risk factors and their impact of quality of life during pregnancy and postpartum period which integrates bladder, bowel and sexual function, pelvic organ prolapse, severity, bothersomeness and conditions specific quality of life in women with urinary incontinence (UI) and/or POP. The questionnaire is divided into four main domains (bladder, bowel, pelvic organ prolapse, sexual function) and each question is scored from zero to three. The additive scores are divided by the maximum reachable score and multiplied by ten, giving a value between zero (0 = no symptoms) and ten (10 = maximum symptoms) for each of the domains.

Locations

Country	Name	City	State
Egypt	sahar M.Y elbaradie	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	subjective pelvic floor-related quality of life symptoms.	the prevalence of pelvic floor disorders during pregnancy and the clinical risk factors which correlate with pelvic floor symptoms during pregnancy.	one year