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临床试验/NCT01321762
NCT01321762已完成不适用

Effect of Pregnancy and Childbirth on the Pelvic Floor

Croydon University Hospital1 个研究点 分布在 1 个国家目标入组 403 人开始时间: 2005年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
403
试验地点
1
主要终点
Objective assessment of Prolapse using Pelvic organ prolapse Quantification System

研究概览

简要总结

Pelvic organ prolapse (POP) is one of the most common indications for gynaecological surgery. In 1997, more than 225000 inpatient surgical procedures for POP were undertaken in USA (22.7 per 10000 women) at an estimated cost of more than one billion dollars. In the UK, the disorder accounts for 20% of the women on the waiting list for major gynaecological surgery. Vaginal birth, advancing age and increasing body mass are the most consistent risk factors. Furthermore a racial and congenital predisposition has been reported. The cause of this disorder is likely to be multifactorial and attributable to a combination of factors, varying from patient to patient.

Controversy exists as to whether the pregnancy per se rather than the mode of delivery alters the risk of POP. Caesarean section appears to protect against the development of prolapse. However, when a caesarean section is undertaken during the active stage of labour it may not be completely protective. Ideally prospective longitudinal studies are needed to study the impact of pregnancy and childbirth on pelvic organ prolapse. Unfortunately, studies to date, are small with poor follow-up and have only assessed objective outcome rendering it difficult to draw conclusions. The primary objective of our study was to objectively assess the impact of pregnancy and childbirth on pelvic organ support using the Pelvic Organ Prolapse Quantification (POPQ)System.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton Pregnancy

排除标准

  • Multiple pregnancies
  • Previous prolapse surgery
  • Medical disorders including diabetes mellitus
  • Inflammatory bowel disease
  • Collagen disorders

结局指标

主要结局

Objective assessment of Prolapse using Pelvic organ prolapse Quantification System

时间窗: 2nd trimester, 3rd trimester, 14 weeks, 12 months and 5 years after childbirth

Prospective evaluation of the impact of mode of delivery on pelvic organ support using the International Continence Society recommended Pelvic Organ Prolapse Quantification system (POPQ).

次要结局

未报告次要终点

研究者

发起方
Croydon University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ranee Thakar

Consultant

Croydon University Hospital

研究点 (1)

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