Pelvic Floor Function Evaluation of Singleton Primiparae After Vaginal Delivery and Cesarean Section
January 22, 2016 updated by: Martin Huser, Brno University Hospital
Pelvic Floor Function Evaluation of Singleton Primiparae After Vaginal Delivery and Cesarean Section: Seven to Twelve-Year Long Observational Cohort Study
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).
Study Overview
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 Type
Observational
Enrollment (Actual)
865
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Primiparae delivered vaginally (VD group) or by cesarean section (CS group) during the years 2002-2007 in university-based large perinatology center
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
VD
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)
|
delivery either vaginal or by cesarean section
|
|
CS
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.
|
delivery either vaginal or by cesarean section
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pelvic organ prolapse symptoms score
Time Frame: seven years after delivery
|
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
Time Frame: seven years after delivery
|
calculated from validated questionnaire Pelvic Organ Prolapse Distress Inventory (POPDI-6)
|
seven years after delivery
|
|
Fecal incontinence symptoms score
Time Frame: seven years after delivery
|
calculated from validated questionnaire Wexner Fecal Incontinence Score (WS)
|
seven years after delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Huser M, Janku P, Hudecek R, Zbozinkova Z, Bursa M, Unzeitig V, Ventruba P. Pelvic floor dysfunction after vaginal and cesarean delivery among singleton primiparas. Int J Gynaecol Obstet. 2017 May;137(2):170-173. doi: 10.1002/ijgo.12116. Epub 2017 Mar 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2002
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
January 16, 2016
First Submitted That Met QC Criteria
January 22, 2016
First Posted (Estimate)
January 25, 2016
Study Record Updates
Last Update Posted (Estimate)
January 25, 2016
Last Update Submitted That Met QC Criteria
January 22, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Plure
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.