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

Completed

• Conditions: Pelvic Floor Disorders
• Interventions: Behavioral: delivery

• Registration Number: NCT02661867
• Lead Sponsor: Brno University Hospital

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2007-12
• Study Completion: 2014-12
• Status Verified: 2016-01
• Study First Submitted: 2016-01-16
• Study First Submitted QC: 2016-01-22
• Last Update Submitted: 2016-01-22
• Study First Posted: 2016-01-25
• Last Update Posted: 2016-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 865

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VD	delivery	Vaginal delivery group - women who gave birth of offspring through the vagina without the use of special instruments such as forceps or a vacuum extractor (instrumental vaginal delivery)
CS	delivery	Cesarean section group - women delivered by surgical procedure in which one or more incisions are made through a mother's abdomen and uterus to deliver a baby. Cesarean section is performed when a vaginal delivery would put the baby's or mother's life or health at risk.

Primary Outcome Measures

Name	Time	Method
Pelvic organ prolapse symptoms score	seven years after delivery	calculated from validated questionnaire International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)

Secondary Outcome Measures

Name	Time	Method
Fecal incontinence symptoms score	seven years after delivery	calculated from validated questionnaire Wexner Fecal Incontinence Score (WS)
Urinary incontinence symptoms score	seven years after delivery	calculated from validated questionnaire Pelvic Organ Prolapse Distress Inventory (POPDI-6)