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

February 16, 2017 updated by: Norwegian University of Science and Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1641

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • St Olavs Hospital Trondheim University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women who delivered their first child at St. Olavs Hospital, Trondheim (Norway) between 1990-1997

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
damage to pelvic floor musculature
Time Frame: 15-20 years after first delivery
15-20 years after first delivery
urinary incontinence
Time Frame: 15-20 years after first delivery
15-20 years after first delivery
anal incontinence
Time Frame: 15-20 years after first delivery
15-20 years after first delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

  • Study Director: Kjell Å Salvesen, prof MD, Norwegian University of Science and Technology
  • Study Director: Siv Mørkved, PhD prof, St. Olavs Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

January 7, 2013

First Submitted That Met QC Criteria

January 9, 2013

First Posted (Estimate)

January 11, 2013

Study Record Updates

Last Update Posted (Actual)

February 17, 2017

Last Update Submitted That Met QC Criteria

February 16, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/666

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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