NCT01766193

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,641 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uterine Prolapse
• Urinary Incontinence
• Fecal Incontinence

Interventions

Type	Name	Description
PROCEDURE	vaginal delivery
PROCEDURE	forceps extraction	vaginal delivery by forceps extraction
PROCEDURE	vacuum extraction	vaginal delivery by vacuum extraction
PROCEDURE	cesarean section

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-01-11
• Last updated: 2017-02-17

Locations

1 site across 1 country: Norway