Delivery Method and Risk for Urogenital Prolapse 15-20 Years Later

Urinary Incontinence Clinical Trial

— uropro  

Official title:

Delivery Method and Risk for Urogenital Prolapse 15-20 Years Later

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766193
• Other study ID #: 2012/666
• Status: Completed
• Phase: N/A
• First received: January 7, 2013
• Last updated: February 16, 2017
• Start date: August 2012
• Est. completion date: February 2014

Study information

• Verified date: February 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1641
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Fecal Incontinence
• Pelvic Organ Prolapse
• Prolapse
• Urinary Incontinence
• Uterine Prolapse

Intervention

Procedure:
• vaginal delivery

• forceps extraction
vaginal delivery by forceps extraction
• vacuum extraction
vaginal delivery by vacuum extraction
• cesarean section

Locations

Country	Name	City	State
Norway	St Olavs Hospital Trondheim University Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (4)

Volløyhaug I, Mørkved S, Salvesen KÅ. 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. — View Citation

Volløyhaug I, Mørkved S, Salvesen Ø, 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. — View Citation

Volløyhaug I, Mørkved S, Salvesen Ø, Salvesen KÅ. 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. — View Citation

Volløyhaug I, Mørkved S, Salvesen Ø, Salvesen KÅ. 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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptoms of urogenital prolapse		15-20 years after first delivery
Primary	surgery for urogenital prolapse		15-20 years after first delivery
Secondary	damage to pelvic floor musculature		15-20 years after first delivery
Secondary	urinary incontinence		15-20 years after first delivery
Secondary	anal incontinence		15-20 years after first delivery