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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02661867

Enrollment

865

Registered

2016-01-25

Start date

2002-01-31

Completion date

2014-12-31

Last updated

2016-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Floor Disorders

Keywords

Childbirth, Pelvic organ prolapse, Urinary incontinence, Fecal incontinence

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.

Interventions

BEHAVIORALdelivery

delivery either vaginal or by cesarean section

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026