Uterine ProlapseuroproNCT01766193
Delivery Method and Risk for Urogenital Prolapse 15-20 Years Later
An observational study of Uterine Prolapse and Urinary Incontinence, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary incontinence is high. Previous studies have shown that pregnancy and childbirth are risk factors for developing prolapse. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Uterine Prolapse, Urinary Incontinence, Fecal Incontinence
- What is being tested?
- vaginal delivery, forceps extraction and vacuum extraction
- Type of treatment
- Surgery or procedure
- How many people
- 1,641 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2012to Feb 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Women who delivered their first child at St. Olavs Hospital, Trondheim (Norway) between 1990-1997
Who may be able to join
- first delivery in time period 1990-1997
- vaginal birth, spontaneous, forceps or vacuum extraction, or cesarean section
- residency in Klæbu, Malvik, Melhus, Midtre Gauldal, Rissa, Selbu, Trondheim, Tydal, Åfjord at the time of first delivery
Who cannot join
- stillbirth
- breech birth
- congenital Abnormalities
- residency outside the 9 selected communities
- forceps delivery following previous vacuum extraction delivery or spontaneous vaginal birth
- vacuum extraction delivery following previous forceps delivery or spontaneous vaginal birth
- Vaginal birth following previous cesarean section
Trial locations and contacts
1 site in 1 country.
About this study
The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary incontinence is high. Previous studies have shown that pregnancy and childbirth are risk factors for developing prolapse. There is a lack of studies that follow women several years after delivery aiming to find whether symptoms of prolapse are linked to delivery method, ie vacuum, forceps, normal vaginal delivery and cesarean section. The investigators plan this study is to get more knowledge about pathology of prolapse and incontinence, to enable development of preventive strategies for these conditions.
Aim of the study is to determine whether the prevalence of symptoms and performed surgery for urogenital prolapse differs among women delivered by vacuum, forceps, normal vaginal delivery and cesarean section 15-20 years after their first delivery.
The investigators identify women that delivered their first child at St. Olavs Hospital, Trondheim, Norway between 1990-1997. Questionnaires will be sent to 2500 women (PFIQ-7, PFDI-20, PISQ-12), 600 of whom will get a clinical examination, where pelvic floor musculature is examined by palpation and 4D ultrasound, and a POP-Q quantification of prolapse performed.
- Conditions
- Uterine Prolapse, Urinary Incontinence, Fecal Incontinence
- Being tested
- vaginal delivery, forceps extraction, vacuum extraction, cesarean section
- Keywords
- Delivery, obstetric, Obstetric Surgical Procedures, Vacuum Extraction, Obstetrical, Cesarean Section, Obstetrical Forceps, Epidemiology, Norway
- Medical subject headings
- Uterine Prolapse, Urinary Incontinence, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal deliveryProcedure or surgery
forceps extractionProcedure or surgery
vaginal delivery by forceps extraction
vacuum extractionProcedure or surgery
vaginal delivery by vacuum extraction
cesarean sectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| vaginal birth | women whose first child was born by spontaneous vaginal delivery Receives: Procedure: vaginal delivery | |
| cesarean section | women whose first child was born by cesarean section Receives: Procedure: cesarean section | |
| forceps | women whose first child was born by forceps extraction Receives: Procedure: forceps extraction | |
| vacuum | women whose first child was born by vacuum extraction Receives: Procedure: vacuum extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptoms of urogenital prolapse
Measured: 15-20 years after first delivery
surgery for urogenital prolapse
Measured: 15-20 years after first delivery
Secondary outcomes (3)
damage to pelvic floor musculature
Measured: 15-20 years after first delivery
urinary incontinence
Measured: 15-20 years after first delivery
anal incontinence
Measured: 15-20 years after first delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startAug 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Uterine ProlapseStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 1,641 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Kjell Å Salvesen, prof MD, Study director, Norwegian University of Science and TechnologySiv Mørkved, PhD prof, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766193
- Sponsor's protocol ID
- 2012/666
- Acronym
- uropro
- Status last verified
- Feb 2017
- First submitted
- 7 Jan 2013
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Volloyhaug I, Morkved S, Salvesen O, Salvesen K. Pelvic organ prolapse and incontinence 15-23 years after first delivery: a cross-sectional study. BJOG. 2015 Jun;122(7):964-71. doi: 10.1111/1471-0528.13322. Epub 2015 Feb 16.
PubMed 25683873Volloyhaug I, Morkved S, Salvesen O, Salvesen KA. Forceps delivery is associated with increased risk of pelvic organ prolapse and muscle trauma: a cross-sectional study 16-24 years after first delivery. Ultrasound Obstet Gynecol. 2015 Oct;46(4):487-95. doi: 10.1002/uog.14891. Epub 2015 Aug 25.
PubMed 25920322Volloyhaug I, Morkved S, Salvesen KA. Association between pelvic floor muscle trauma and pelvic organ prolapse 20 years after delivery. Int Urogynecol J. 2016 Jan;27(1):39-45. doi: 10.1007/s00192-015-2784-8. Epub 2015 Jul 22.
PubMed 26198007Volloyhaug I, Morkved S, Salvesen O, Salvesen KA. Assessment of pelvic floor muscle contraction with palpation, perineometry and transperineal ultrasound: a cross-sectional study. Ultrasound Obstet Gynecol. 2016 Jun;47(6):768-73. doi: 10.1002/uog.15731. Epub 2016 May 2.
PubMed 26300128
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivery Method and Risk for Urogenital Prolapse 15-20 Years Later
- ClinicalTrials.gov ID
- NCT01766193
- Acronym / sponsor ID
- uropro / 2012/666
- Conditions
- Uterine Prolapse, Urinary Incontinence, Fecal Incontinence
- Keywords
- Delivery, obstetric, Obstetric Surgical Procedures, Vacuum Extraction, Obstetrical, Cesarean Section, Obstetrical Forceps, Epidemiology, Norway
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,641 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Aug 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 11 Jan 2013 (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.
The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary incontinence is high. Previous studies have shown that pregnancy and childbirth are risk factors for developing prolapse. There is a lack of studies that follow women several years after delivery aiming to find whether symptoms of prolapse are linked to delivery method, ie vacuum, forceps, normal vaginal delivery and cesarean section. The investigators plan this study is to get more knowledge about pathology of prolapse and incontinence, to enable development of preventive strategies for these conditions.
Aim of the study is to determine whether the prevalence of symptoms and performed surgery for urogenital prolapse differs among women delivered by vacuum, forceps, normal vaginal delivery and cesarean section 15-20 years after their first delivery.
The investigators identify women that delivered their first child at St. Olavs Hospital, Trondheim, Norway between 1990-1997. Questionnaires will be sent to 2500 women (PFIQ-7, PFDI-20, PISQ-12), 600 of whom will get a clinical examination, where pelvic floor musculature is examined by palpation and 4D ultrasound, and a POP-Q quantification of prolapse performed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| vaginal birth | – | Procedure: vaginal deliverywomen whose first child was born by spontaneous vaginal delivery |
| cesarean section | – | Procedure: cesarean sectionwomen whose first child was born by cesarean section |
| forceps | – | Procedure: forceps extractionwomen whose first child was born by forceps extraction |
| vacuum | – | Procedure: vacuum extractionwomen whose first child was born by vacuum extraction |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who delivered their first child at St. Olavs Hospital, Trondheim (Norway) between 1990-1997
Key inclusion criteria (3 listed)
- first delivery in time period 1990-1997
- vaginal birth, spontaneous, forceps or vacuum extraction, or cesarean section
- residency in Klæbu, Malvik, Melhus, Midtre Gauldal, Rissa, Selbu, Trondheim, Tydal, Åfjord at the time of first delivery
Key exclusion criteria (7 listed)
- stillbirth
- breech birth
- congenital Abnormalities
- residency outside the 9 selected communities
- forceps delivery following previous vacuum extraction delivery or spontaneous vaginal birth
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 |
|---|---|---|
| vaginal delivery | Procedure or surgery | vaginal birth |
| forceps extractionvaginal delivery by forceps extraction | Procedure or surgery | forceps |
| vacuum extractionvaginal delivery by vacuum extraction | Procedure or surgery | vacuum |
| cesarean section | Procedure or surgery | cesarean section |
Primary outcome
symptoms of urogenital prolapse
Time frame: 15-20 years after first delivery
surgery for urogenital prolapse
Time frame: 15-20 years after first delivery
3 secondary outcomes
damage to pelvic floor musculature
Time frame: 15-20 years after first delivery
urinary incontinence
Time frame: 15-20 years after first delivery
anal incontinence
Time frame: 15-20 years after first 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 17 Feb 2017.
- Results publication: PubMed 25683873Volloyhaug I, Morkved S, Salvesen O, Salvesen K. Pelvic organ prolapse and incontinence 15-23 years after first delivery: a cross-sectional study. BJOG. 2015 Jun;122(7):964-71. doi: 10.1111/1471-0528.13322. Epub 2015 Feb 16.
- Results publication: PubMed 25920322Volloyhaug I, Morkved S, Salvesen O, Salvesen KA. Forceps delivery is associated with increased risk of pelvic organ prolapse and muscle trauma: a cross-sectional study 16-24 years after first delivery. Ultrasound Obstet Gynecol. 2015 Oct;46(4):487-95. doi: 10.1002/uog.14891. Epub 2015 Aug 25.
- Results publication: PubMed 26198007Volloyhaug I, Morkved S, Salvesen KA. Association between pelvic floor muscle trauma and pelvic organ prolapse 20 years after delivery. Int Urogynecol J. 2016 Jan;27(1):39-45. doi: 10.1007/s00192-015-2784-8. Epub 2015 Jul 22.
- Results publication: PubMed 26300128Volloyhaug I, Morkved S, Salvesen O, Salvesen KA. Assessment of pelvic floor muscle contraction with palpation, perineometry and transperineal ultrasound: a cross-sectional study. Ultrasound Obstet Gynecol. 2016 Jun;47(6):768-73. doi: 10.1002/uog.15731. Epub 2016 May 2.
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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.
Kjell Å Salvesen, prof MD study director
Norwegian University of Science and Technology
Siv Mørkved, PhD prof study director
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Prolapse and Urinary Incontinence, run by Norwegian University of Science and Technology at 1 site in Norway.
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 3 inclusion and 7 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 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
symptoms of urogenital prolapse (time frame: 15-20 years after first delivery). The study lists 2 primary outcomes in all. 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 NCT01766193, which also lists 4 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 17 Feb 2017.