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

Completed

• Conditions: Urinary Incontinence; Uterine Prolapse; Fecal Incontinence
• Interventions: Procedure: vaginal delivery; Procedure: cesarean section; Procedure: forceps extraction; Procedure: vacuum extraction

• Registration Number: NCT01766193
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-01-07
• Study First Submitted QC: 2013-01-09
• Study First Posted: 2013-01-11
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1641

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
vaginal birth	vaginal delivery	women whose first child was born by spontaneous vaginal delivery
cesarean section	cesarean section	women whose first child was born by cesarean section
forceps	forceps extraction	women whose first child was born by forceps extraction
vacuum	vacuum extraction	women whose first child was born by vacuum extraction

Primary Outcome Measures

Name	Time	Method
symptoms of urogenital prolapse	15-20 years after first delivery
surgery for urogenital prolapse	15-20 years after first delivery

Secondary Outcome Measures

Name	Time	Method
damage to pelvic floor musculature	15-20 years after first delivery
anal incontinence	15-20 years after first delivery
urinary incontinence	15-20 years after first delivery

Trial Locations

Locations (1)

St Olavs Hospital Trondheim University Hospital; 🇳🇴 Trondheim, Norway