Skip to main content
OpenTrials
Completed

NCT Number: NCT01766193

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Uterine Prolapse Digestive System Diseases Fecal Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Genital Diseases Genital Diseases, Female Intestinal Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Rectal Diseases Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Uterine Diseases

Age range

40 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

St Olavs Hospital Trondheim University Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaginal delivery

Procedure

forceps extraction

Procedure

vaginal delivery by forceps extraction

vacuum extraction

Procedure

vaginal delivery by vacuum extraction

cesarean section

Procedure

Primary outcomes

  1. symptoms of urogenital prolapse

    Time frame: 15-20 years after first delivery

  2. surgery for urogenital prolapse

    Time frame: 15-20 years after first delivery

Secondary outcomes

  1. damage to pelvic floor musculature

    Time frame: 15-20 years after first delivery

  2. urinary incontinence

    Time frame: 15-20 years after first delivery

  3. anal incontinence

    Time frame: 15-20 years after first delivery

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Acronym: uropro

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 11, 2013
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.