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

NCT01766193 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1641

Last updated 2017-02-17

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

vaginal delivery

PROCEDURE

forceps extraction

vaginal delivery by forceps extraction

PROCEDURE

vacuum extraction

vaginal delivery by vacuum extraction

PROCEDURE

cesarean section

Sponsors & Collaborators

  • St. Olavs Hospital

    collaborator OTHER
  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Kjell Å Salvesen, prof MD · Norwegian University of Science and Technology

  • Siv Mørkved, PhD prof · St. Olavs Hospital

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Norway

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01766193 on ClinicalTrials.gov