Delivery Method and Risk for Urogenital Prolapse 15-20 Years Later
uropro
1 other identifier
observational
1,641
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
Started Aug 2012
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 7, 2013
CompletedFirst Posted
Study publicly available on registry
January 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFebruary 17, 2017
February 1, 2017
1.5 years
January 7, 2013
February 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
symptoms of urogenital prolapse
15-20 years after first delivery
surgery for urogenital prolapse
15-20 years after first delivery
Secondary Outcomes (3)
damage to pelvic floor musculature
15-20 years after first delivery
urinary incontinence
15-20 years after first delivery
anal incontinence
15-20 years after first delivery
Study Arms (4)
vaginal birth
women whose first child was born by spontaneous vaginal delivery
cesarean section
women whose first child was born by cesarean section
forceps
women whose first child was born by forceps extraction
vacuum
women whose first child was born by vacuum extraction
Interventions
Eligibility Criteria
Women who delivered their first child at St. Olavs Hospital, Trondheim (Norway) between 1990-1997
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- St. Olavs Hospitalcollaborator
Study Sites (1)
St Olavs Hospital Trondheim University Hospital
Trondheim, Norway
Related Publications (4)
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.
PMID: 25683873RESULTVolloyhaug 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.
PMID: 25920322RESULTVolloyhaug 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.
PMID: 26198007RESULTVolloyhaug 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.
PMID: 26300128RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kjell Å Salvesen, prof MD
Norwegian University of Science and Technology
- STUDY DIRECTOR
Siv Mørkved, PhD prof
St. Olavs Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2013
First Posted
January 11, 2013
Study Start
August 1, 2012
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
February 17, 2017
Record last verified: 2017-02