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

Sponsor

Norwegian University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT01766193

Collaborator

St. Olavs Hospital (Other)

1,641

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Prolapse Urinary Incontinence Fecal Incontinence	Procedure: vaginal delivery Procedure: forceps extraction Procedure: vacuum extraction Procedure: cesarean section

Study Design

Study Type:

Observational

Actual Enrollment :

1641 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
vaginal birth women whose first child was born by spontaneous vaginal delivery	Procedure: vaginal delivery
cesarean section women whose first child was born by cesarean section	Procedure: cesarean section
forceps women whose first child was born by forceps extraction	Procedure: forceps extraction vaginal delivery by forceps extraction
vacuum women whose first child was born by vacuum extraction	Procedure: vacuum extraction vaginal delivery by vacuum extraction

Outcome Measures

Primary Outcome Measures

symptoms of urogenital prolapse [15-20 years after first delivery]
surgery for urogenital prolapse [15-20 years after first delivery]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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