Clinical trial NCT01766193: Delivery Method and Risk for Urogenital Prolapse 15-20 Years Later
Official title: Delivery Method and Risk for Urogenital Prolapse 15-20 Years Later
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Prolapse
Urinary Incontinence
Fecal Incontinence
Keywords: Delivery, obstetric
Obstetric Surgical Procedures
Vacuum Extraction, Obstetrical
Cesarean Section
Obstetrical Forceps
Epidemiology
Norway
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2013-01-11
Enrollment: 1641
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who delivered their first child at St. Olavs Hospital, Trondheim (Norway) between 1990-1997

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: symptoms of urogenital prolapse
timeFrame: 15-20 years after first delivery
measure: surgery for urogenital prolapse
timeFrame: 15-20 years after first delivery
Secondary outcomes:
measure: damage to pelvic floor musculature
timeFrame: 15-20 years after first delivery
measure: urinary incontinence
timeFrame: 15-20 years after first delivery
measure: anal incontinence
timeFrame: 15-20 years after first delivery
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital Trondheim University Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Kjell Å Salvesen, prof MD
role: STUDY_DIRECTOR
affiliation: St. Olavs Hospital
name: Siv Mørkved, PhD prof
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Volloyhaug 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.
citation: Volloyhaug 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.
citation: Volloyhaug 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.