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NCT02661867 Clinical Trial

Pelvic Floor Function Evaluation of Singleton Primiparae After Vaginal Delivery and Cesarean Section

Pelvic Floor Disorders Clinical Trial

Official title:
Pelvic Floor Function Evaluation of Singleton Primiparae After Vaginal Delivery and Cesarean Section: Seven to Twelve-Year Long Observational Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02661867
Other study ID # Plure
Secondary ID
Status Completed
Phase N/A
First received January 16, 2016
Last updated January 22, 2016
Start date January 2002
Est. completion date December 2014

Study information
Verified date January 2016
Source Brno University Hospital
Contact n/a
Is FDA regulated No
Health authority Czech Republic: Ministry of Health
Study type Observational

Clinical Trial Summary

Objective of this longitudinal observational cohort study was to analyze incidence of pelvic floor dysfunction (PFD) symptoms, including pelvic organ prolapse (POP), urinary incontinence (UI), and fecal incontinence (FI), seven to twelve years after delivery, in two groups of singleton primiparae after vaginal delivery (VD) and cesarean section (CS).

Description:

Pelvic floor disorders (PFD) usually refers to three definable groups of symptoms that include pelvic organ prolapse (POP), urinary incontinence (UI), and fecal incontinence (FI). The prevalence of these conditions increases with age, but in general, PFD affect 20-50 % of women throughout their lives. Thus, PFD are common and have significant societal impact. Another important PFD risk factor is childbearing. Specifically, these disorders are more common among multiparas. Vaginal delivery (VD) has been considered the main contributing factor because of pelvic floor muscle, fascia, and nerves damage.

Recruitment information / eligibility
Status Completed
Enrollment 865
Est. completion date December 2014
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- singleton pregnancy

- cephalic presentation

- delivery in term (gestational week 38-42)

- no other childbirth during study period

Exclusion Criteria:

- operative vaginal delivery (vacuum extraction or forceps delivery)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Behavioral:
• delivery
delivery either vaginal or by cesarean section

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Brno University Hospital

References & Publications (1)

Memon H, Handa VL. Pelvic floor disorders following vaginal or cesarean delivery. Curr Opin Obstet Gynecol. 2012 Oct;24(5):349-54. doi: 10.1097/GCO.0b013e328357628b. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pelvic organ prolapse symptoms score calculated from validated questionnaire International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) seven years after delivery No
Secondary Urinary incontinence symptoms score calculated from validated questionnaire Pelvic Organ Prolapse Distress Inventory (POPDI-6) seven years after delivery No
Secondary Fecal incontinence symptoms score calculated from validated questionnaire Wexner Fecal Incontinence Score (WS) seven years after delivery No
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