Pelvic Floor DisordersNCT02661867
Pelvic Floor Function Evaluation of Singleton Primiparae After Vaginal Delivery and Cesarean Section
An observational study of Pelvic Floor Disorders, run by Brno University Hospital.
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- delivery
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 865 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primiparae delivered vaginally (VD group) or by cesarean section (CS group) during the years 2002-2007 in university-based large perinatology center
Who may be able to join
- singleton pregnancy
- cephalic presentation
- delivery in term (gestational week 38-42)
- no other childbirth during study period
Who cannot join
- operative vaginal delivery (vacuum extraction or forceps delivery)
About this study
Official title: 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).
Read the 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.
- Conditions
- Pelvic Floor Disorders
- Being tested
- delivery
- Keywords
- Childbirth, Pelvic organ prolapse, Urinary incontinence, Fecal incontinence
- Medical subject headings
- Pelvic Floor Disorders, Pelvic Organ Prolapse, Urinary Incontinence, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deliveryBehavioural
delivery either vaginal or by cesarean section
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: delivery | |
| 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. Receives: Behavioral: delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic organ prolapse symptoms score
calculated from validated questionnaire International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Measured: seven years after delivery
Secondary outcomes (2)
Urinary incontinence symptoms score
calculated from validated questionnaire Pelvic Organ Prolapse Distress Inventory (POPDI-6)
Measured: seven years after delivery
Fecal incontinence symptoms score
calculated from validated questionnaire Wexner Fecal Incontinence Score (WS)
Measured: seven years after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startJan 2002
- Primary completionDec 2007
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 865 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Huser, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661867
- Sponsor's protocol ID
- Plure
- Status last verified
- Jan 2016
- First submitted
- 16 Jan 2016
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 22907482Huser 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.
PubMed 28171703
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Function Evaluation of Singleton Primiparae After Vaginal Delivery and Cesarean Section: Seven to Twelve-Year Long Observational Cohort Study
- ClinicalTrials.gov ID
- NCT02661867
- Acronym / sponsor ID
- Plure
- Conditions
- Pelvic Floor Disorders
- Keywords
- Childbirth, Pelvic organ prolapse, Urinary incontinence, Fecal incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 865 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VD | – | Behavioral: deliveryVaginal 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 | – | Behavioral: deliveryCesarean 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primiparae delivered vaginally (VD group) or by cesarean section (CS group) during the years 2002-2007 in university-based large perinatology center
Key inclusion criteria (4 listed)
- singleton pregnancy
- cephalic presentation
- delivery in term (gestational week 38-42)
- no other childbirth during study period
Key exclusion criteria (1 listed)
- operative vaginal delivery (vacuum extraction or forceps delivery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deliverydelivery either vaginal or by cesarean section | Behavioural | CS, VD |
Primary outcome
Pelvic organ prolapse symptoms score
Time frame: seven years after delivery
calculated from validated questionnaire International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
2 secondary outcomes
Urinary incontinence symptoms score
Time frame: seven years after delivery
Fecal incontinence symptoms score
Time frame: seven years after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
- Background: PubMed 22907482Memon 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.
- Derived from this study: PubMed 28171703Huser 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Disorders, run by Brno University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic organ prolapse symptoms score (time frame: seven years after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02661867, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2016.