Trial record 7 of 18 for:    Open Studies | "Uterine Prolapse"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Norwegian University of Science and Technology
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01766193
First received: January 7, 2013
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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 Intervention
Uterine Prolapse
Urinary Incontinence
Fecal Incontinence
Procedure: vaginal delivery
Procedure: forceps extraction
Procedure: vacuum extraction
Procedure: cesarean section

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Delivery Method and Risk for Urogenital Prolapse 15-20 Years Later

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • symptoms of urogenital prolapse [ Time Frame: 15-20 years after first delivery ] [ Designated as safety issue: No ]
  • surgery for urogenital prolapse [ Time Frame: 15-20 years after first delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • damage to pelvic floor musculature [ Time Frame: 15-20 years after first delivery ] [ Designated as safety issue: No ]
  • urinary incontinence [ Time Frame: 15-20 years after first delivery ] [ Designated as safety issue: No ]
  • anal incontinence [ Time Frame: 15-20 years after first delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 2200
Study Start Date: August 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766193

Contacts
Contact: Ingrid Volløyhaug ingrid.volloyhaug@ntnu.no

Locations
Norway
St Olavs Hospital Trondheim University Hospital Recruiting
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
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
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01766193     History of Changes
Other Study ID Numbers: 2012/666
Study First Received: January 7, 2013
Last Updated: April 16, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
Delivery, obstetric
Obstetric Surgical Procedures
Vacuum Extraction, Obstetrical
Cesarean Section
Obstetrical Forceps
Epidemiology
Norway

Additional relevant MeSH terms:
Uterine Prolapse
Fecal Incontinence
Prolapse
Urinary Incontinence
Pelvic Organ Prolapse
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 28, 2014