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

Study Overview
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Brief Summary
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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.

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

Conditions
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Uterine Prolapse, Urinary Incontinence, Fecal Incontinence

Intervention / Treatment
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* Procedure: vaginal delivery
* Procedure: forceps extraction
* Procedure: vacuum extraction
* Procedure: cesarean section


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| vaginal birth<br>women whose first child was born by spontaneous vaginal delivery | Procedure: vaginal delivery<br> <br> |
| cesarean section<br>women whose first child was born by cesarean section | Procedure: cesarean section<br> <br> |
| forceps<br>women whose first child was born by forceps extraction | Procedure: forceps extraction<br>* vaginal delivery by forceps extraction<br>|
| vacuum<br>women whose first child was born by vacuum extraction | Procedure: vacuum extraction<br>* vaginal delivery by vacuum extraction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms of urogenital prolapse |  | 15-20 years after first delivery | 
| surgery for urogenital prolapse |  | 15-20 years after first delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delivery, obstetric, Obstetric Surgical Procedures, Vacuum Extraction, Obstetrical, Cesarean Section, Obstetrical Forceps, Epidemiology, Norway