跳至主要内容
临床试验/NCT01766193
NCT01766193已完成不适用

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

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 1,641 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,641
试验地点
1
主要终点
symptoms of urogenital prolapse

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

symptoms of urogenital prolapse

时间窗: 15-20 years after first delivery

surgery for urogenital prolapse

时间窗: 15-20 years after first delivery

次要结局

  • damage to pelvic floor musculature(15-20 years after first delivery)
  • anal incontinence(15-20 years after first delivery)
  • urinary incontinence(15-20 years after first delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验