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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pelvic Floor Disorders

Intervention / Treatment
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* Behavioral: delivery


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VD<br>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) | Behavioral: delivery<br>* delivery either vaginal or by cesarean section<br>|
| CS<br>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. | Behavioral: delivery<br>* delivery either vaginal or by cesarean section<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic organ prolapse symptoms score | calculated from validated questionnaire International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) | seven years after delivery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Childbirth, Pelvic organ prolapse, Urinary incontinence, Fecal incontinence